CompletedNCT01763866LAPLACE-2Updated Nov 8, 2022Results posted

LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2

A Phase 3 interventional study of Evolocumab and Ezetimibe in Hyperlipidemia, sponsored by Amgen. Completed at 244 sites in 21 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-11-08.

Sponsored by Amgen · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 2,067
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study summary

The primary objective was to evaluate the effect of 12 weeks of evolocumab administered subcutaneously every 2 weeks (Q2W) and monthly (QM) when used in combination with a statin, compared with placebo, on percent change from baseline in low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia and mixed dyslipidemia.

Read the detailed description

Prior to the first randomization, participants entered a screening period to determine eligibility. During screening, all participants received subcutaneous placebo corresponding to the once monthly dose volume. Participants who completed the screening period and met eligibility criteria were randomized to 1 of 5 open-label statin cohorts (atorvastatin 10 mg or 80 mg, rosuvastatin 5 mg or 40 mg, or simvastatin 40 mg) for a 4 week lipid stabilization period based on statin therapy at the time of study entry (no statin use vs non-intensive statin use vs intensive statin use).

After the 4-week lipid-stabilization period, eligible patients taking rosuvastatin or simvastatin during the lipid-stabilization phase were then randomized to 1 of 4 treatment groups: evolocumab (140 mg, subcutaneous, every 2 weeks) or matching placebo (subcutaneous, every 2 weeks), or evolocumab (420 mg, subcutaneous, monthly) or matching placebo (subcutaneous, monthly). Patients taking atorvastatin during the lipid-stabilization phase were then randomized to 1 of 6 treatment groups: evolocumab (140 mg, subcutaneous, every 2 weeks) and placebo (oral, daily), evolocumab (420 mg, subcutaneous, monthly) and placebo (oral, daily), placebo (subcutaneous, every 2 weeks) and placebo (oral, daily) or ezetimibe (10 mg, oral, daily), or placebo (subcutaneous, monthly) and placebo (oral, daily) or ezetimibe (10 mg, oral, daily).

A participant was considered randomized into the study after successfully completing the screening period, meeting all inclusion/exclusion criteria, and undergoing both randomization procedures.

Participants randomized to simvastatin who were taking verapamil or diltiazem prior to randomization received simvastatin 10 mg once daily (QD) while participants who were taking amlodipine, amiodarone or ranolazine prior to randomization received simvastatin 20 mg QD. All other participants randomized to simvastatin received simvastatin 40 mg QD.

Conditions studied

Hyperlipidemia

Browse trials for

Hyperlipidemias 821

Keywords

High cholesterol, Treatment for high cholesterol, Lowering cholesterol, Lowering high cholesterol, Hypercholesterolemia

In context

Hyperlipidemias

821 studies on the registry are indexed under Hyperlipidemias; 105 are open to participants now.

This study's enrollment of 2,067 is above the median of 87 across 691 interventional studies indexed under Hyperlipidemias.

Browse Hyperlipidemias studies →

Lead sponsor

Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.

Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Male or female ≥ 18 to ≤ 80 years of age
Subjects not taking a statin must have fasting LDL-C of at least 150 mg/dL (4.0 mmol/L)
Subjects already on a non-intensive statin must have fasting LDL-C at screening ≥ 100 mg/dL (2.6 mmol/L)
Subjects already on a intensive statin must have fasting LDL-C at screening ≥ 80 mg/dL (2.1 mmol/L)
Fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L)

Exclusion criteria

Exclusion Criteria:

Statin intolerance
New York Heart association (NYHA) III or IV heart failure
Uncontrolled hypertension
Uncontrolled cardiac arrhythmia
Type 1 diabetes, poorly controlled type 2 diabetes
Uncontrolled hypothyroidism or hyperthyroidism

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 2,067 participants (actual)

Study arms

Placebo comparator
A10 PBO Q2W
Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
Drug: Placebo to Evolocumab · Drug: Placebo to Ezetimibe · Drug: Atorvastatin
Placebo comparator
A10 PBO QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
Drug: Placebo to Evolocumab · Drug: Placebo to Ezetimibe · Drug: Atorvastatin
Active comparator
A10 EZE (Q2W)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once a day for up to 12 weeks.
Drug: Ezetimibe · Drug: Placebo to Evolocumab · Drug: Atorvastatin
Active comparator
A10 EZE (QM)
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
Drug: Ezetimibe · Drug: Placebo to Evolocumab · Drug: Atorvastatin
Experimental
A10 EvoMab Q2W
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
Biological: Evolocumab · Drug: Placebo to Ezetimibe · Drug: Atorvastatin
Experimental
A10 EvoMab QM
Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks
Biological: Evolocumab · Drug: Placebo to Ezetimibe · Drug: Atorvastatin
Placebo comparator
A80 PBO Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
Drug: Placebo to Evolocumab · Drug: Placebo to Ezetimibe · Drug: Atorvastatin
Placebo comparator
A80 PBO QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month and placebo tablets once a day for up to 12 weeks.
Drug: Placebo to Evolocumab · Drug: Placebo to Ezetimibe · Drug: Atorvastatin
Active comparator
A80 EZE (Q2W)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
Drug: Ezetimibe · Drug: Placebo to Evolocumab · Drug: Atorvastatin
Active comparator
A80 EZE (QM)
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
Drug: Ezetimibe · Drug: Placebo to Evolocumab · Drug: Atorvastatin
Experimental
A80 EvoMab Q2W
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
Biological: Evolocumab · Drug: Placebo to Ezetimibe · Drug: Atorvastatin
Experimental
A80 EvoMab QM
Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
Biological: Evolocumab · Drug: Placebo to Ezetimibe · Drug: Atorvastatin
Placebo comparator
R5 PBO Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
Drug: Placebo to Evolocumab · Drug: Rosuvastatin
Placebo comparator
R5 PBO QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month for up to 12 weeks.
Drug: Placebo to Evolocumab · Drug: Rosuvastatin
Experimental
R5 EvoMab Q2W
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
Biological: Evolocumab · Drug: Rosuvastatin
Experimental
R5 EvoMab QM
Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Biological: Evolocumab · Drug: Rosuvastatin
Placebo comparator
R40 PBO Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
Drug: Placebo to Evolocumab · Drug: Rosuvastatin
Placebo comparator
R40 PBO QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month for up to 12 weeks.
Drug: Placebo to Evolocumab · Drug: Rosuvastatin
Experimental
R40 EvoMab Q2W
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
Biological: Evolocumab · Drug: Rosuvastatin
Experimental
R40 EvoMab QM
Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Biological: Evolocumab · Drug: Rosuvastatin
Placebo comparator
S40 PBO Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
Drug: Placebo to Evolocumab · Drug: Simvastatin
Placebo comparator
S40 PBO QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then with placebo subcutaneous injection once every month for up to 12 weeks.
Drug: Placebo to Evolocumab · Drug: Simvastatin
Experimental
S40 EvoMab Q2W
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
Biological: Evolocumab · Drug: Simvastatin
Experimental
S40 EvoMab QM
Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
Biological: Evolocumab · Drug: Simvastatin

Interventions

BiologicalEvolocumab
Administered by subcutaneous injection
Also known as: AMG 145, Repatha
DrugEzetimibe
Administered orally once a day
Also known as: Zetia
DrugPlacebo to Evolocumab
Administered by subcutaneous injection
DrugPlacebo to Ezetimibe
Administered orally once a day
DrugAtorvastatin
Administered orally once a day
Also known as: Lipitor
DrugRosuvastatin
Administered orally once a day
Also known as: Crestor
DrugSimvastatin
Administered orally once a day
Also known as: Zocor

What researchers measure

Primary outcomes

Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12

Secondary outcomes

Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Change From Baseline in LDL-C at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Percent Change From Baseline in Non-HDL-C at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
Time frame: Baseline and Week 12
Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL
Time frame: Weeks 10 and 12
Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12
Time frame: Week 12
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Percent Change From Baseline in Lipoprotein(a) at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Percent Change From Baseline in Triglycerides at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12
Time frame: Baseline and Week 12
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
Time frame: Baseline and Weeks 10 and 12
Percent Change From Baseline in HDL-C at Week 12
Time frame: Baseline and Week 12

Results

Posted Dec 22, 2015

Participant flow

Adults aged 18 to 80 years with screening low-density lipoprotein cholesterol (LDL-C) ≥ 150 mg/dL (no statin at screening), ≥ 100 mg/dL (non-intensive statin at screening), or ≥ 80 mg/dL (intensive statin at screening) and fasting triglycerides ≤ 400 mg/dL. First patient enrolled on 15 January 2013; Last patient enrolled on 10 July 2013.

Participant flow — Overall Study
Milestone	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Started	56	55	56	55	110	110	55	55	56	54	110	110	58	57	114	115	56	56	111	112	56	55	112	115
Received treatment	56	55	56	55	110	110	55	55	56	54	109	110	58	57	113	115	56	55	111	112	56	55	112	115
Completed	54	54	51	55	108	107	48	55	53	53	102	108	54	57	102	112	55	55	105	110	52	54	109	113
Not completed	2	1	5	0	2	3	7	0	3	1	8	2	4	0	12	3	1	1	6	2	4	1	3	2
Withdrew: Withdrawal by subject	2	1	4	0	0	3	4	0	1	1	2	2	2	0	6	3	0	1	1	1	2	1	2	1
Withdrew: Decision by sponsor	0	0	1	0	2	0	2	0	2	0	6	0	1	0	5	0	0	0	4	0	2	0	1	0
Withdrew: Lost to follow-up	0	0	0	0	0	0	1	0	0	0	0	0	1	0	1	0	0	0	1	1	0	0	0	1
Withdrew: Death	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0

Outcome measures

PrimaryPercent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12

Time frame:: Baseline and Week 12
Reported as:: Least squares mean · percent change

Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
percent change	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12	9.86 ± 2.53	0.97 ± 2.82	-21.96 ± 2.63	-17.08 ± 2.78	-61.56 ± 1.81	-58.19 ± 1.99	14.49 ± 4.42	11.83 ± 3.85	-14.60 ± 4.29	-19.80 ± 3.85	-61.80 ± 3.04	-58.68 ± 2.74	8.12 ± 2.68	5.10 ± 2.62	-60.09 ± 1.94	-59.40 ± 1.87	9.42 ± 3.60	2.59 ± 4.30	-58.89 ± 2.58	-52.40 ± 2.98	4.70 ± 3.61	3.40 ± 4.94	-65.86 ± 3.05	-57.02 ± 3.93

Statistical analysis

A10 PBO Q2W vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -71.42 · 95% CI -77.55 to -65.29The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 PBO QM vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -59.16 · 95% CI -65.94 to -52.38The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (Q2W) vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -39.60 · 95% CI -45.81 to -33.40The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (QM) vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -41.10 · 95% CI -47.83 to -34.37The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO Q2W vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -76.29 · 95% CI -86.87 to -65.72The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO QM vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -70.51 · 95% CI -79.81 to -61.20The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (Q2W) vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -47.20 · 95% CI -57.54 to -36.86The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (QM) vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -38.88 · 95% CI -48.21 to -29.56The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO Q2W vs R5 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -68.21 · 95% CI -74.72 to -61.70The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO QM vs R5 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -64.49 · 95% CI -70.84 to -58.14The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO Q2W vs R40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -68.31 · 95% CI -77.04 to -59.57The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO QM vs R40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -54.98 · 95% CI -65.31 to -44.65The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO Q2W vs S40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -70.56 · 95% CI -76.72 to -64.41The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO QM vs S40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -60.41 · 95% CI -69.11 to -51.72The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit

PrimaryPercent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12

Time frame:: Baseline and Weeks 10 and 12
Reported as:: Least squares mean · percent change

Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
percent change	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Percent Change From Baseline in LDL-C at the Mean of Weeks 10 and 12	8.54 ± 2.24	0.35 ± 2.60	-23.88 ± 2.34	-18.98 ± 2.57	-61.41 ± 1.61	-62.47 ± 1.83	13.12 ± 3.99	9.76 ± 3.39	-16.85 ± 3.88	-21.25 ± 3.42	-61.80 ± 2.77	-65.05 ± 2.42	7.55 ± 2.39	2.79 ± 2.50	-59.33 ± 1.74	-63.79 ± 1.76	6.57 ± 3.11	-0.02 ± 3.51	-59.08 ± 2.23	-62.94 ± 2.44	3.26 ± 3.40	6.00 ± 4.80	-66.17 ± 2.93	-62.45 ± 3.85

Statistical analysis

A10 PBO Q2W vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -69.95 · 95% CI -75.38 to -64.51The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 PBO QM vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -62.82 · 95% CI -69.06 to -56.57The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (Q2W) vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -37.53 · 95% CI -43.03 to -32.03The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (QM) vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -43.49 · 95% CI -49.70 to -37.28The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO Q2W vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -74.92 · 95% CI -84.49 to -65.35The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO QM vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -74.81 · 95% CI -83.00 to -66.62The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (Q2W) vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -44.95 · 95% CI -54.32 to -35.57The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (QM) vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -43.81 · 95% CI -52.06 to -35.55The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO Q2W vs R5 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -66.88 · 95% CI -72.67 to -61.08The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO QM vs R5 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -66.58 · 95% CI -72.60 to -60.56The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO Q2W vs R40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -65.66 · 95% CI -73.19 to -58.12The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO QM vs R40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -62.91 · 95% CI -71.37 to -54.46The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO Q2W vs S40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -69.43 · 95% CI -74.86 to -64.01The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO QM vs S40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -68.45 · 95% CI -76.68 to -60.22The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit

SecondaryChange From Baseline in LDL-C at at the Mean of Weeks 10 and 12

Time frame:: Baseline and Weeks 10 and 12
Reported as:: Least squares mean · mg/dL

Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12
mg/dL	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Change From Baseline in LDL-C at at the Mean of Weeks 10 and 12	6.8 ± 3.7	-0.4 ± 4.4	-32.4 ± 3.8	-25.1 ± 4.3	-76.8 ± 2.7	-80.1 ± 3.1	11.0 ± 5.0	5.5 ± 3.7	-13.0 ± 4.9	-21.3 ± 3.7	-58.8 ± 3.5	-60.1 ± 2.6	6.5 ± 3.5	0.1 ± 4.2	-68.9 ± 2.5	-77.8 ± 3.0	3.4 ± 3.0	-4.8 ± 4.2	-52.3 ± 2.2	-55.3 ± 2.9	-5.7 ± 5.2	1.7 ± 6.5	-83.8 ± 4.5	-78.4 ± 5.1

Statistical analysis

A10 PBO Q2W vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -83.6 · 95% CI -92.6 to -74.6The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 PBO QM vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -79.7 · 95% CI -90.2 to -69.2The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (Q2W) vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -44.4 · 95% CI -53.4 to -35.3The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (QM) vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -55.0 · 95% CI -65.4 to -44.6The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO Q2W vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -69.9 · 95% CI -81.9 to -57.8The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO QM vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -65.6 · 95% CI -74.5 to -56.7The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (Q2W) vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -45.8 · 95% CI -57.7 to -33.9The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (QM) vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -38.8 · 95% CI -47.8 to -29.9The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO Q2W vs R5 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -75.4 · 95% CI -83.9 to -67.0The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO QM vs R5 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -77.9 · 95% CI -88.0 to -67.8The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO Q2W vs R40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -55.8 · 95% CI -63.1 to -48.4The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO QM vs R40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -50.6 · 95% CI -60.6 to -40.6The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO Q2W vs S40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -78.1 · 95% CI -86.2 to -70.0The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO QM vs S40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -80.1 · 95% CI -91.7 to -68.6The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit

SecondaryChange From Baseline in LDL-C at Week 12

Time frame:: Baseline and Week 12
Reported as:: Least squares mean · mg/dL

Change From Baseline in LDL-C at Week 12
mg/dL	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Change From Baseline in LDL-C at Week 12	8.6 ± 4.0	0.8 ± 4.5	-30.1 ± 4.1	-23.3 ± 4.5	-77.0 ± 2.9	-75.1 ± 3.2	12.7 ± 5.3	7.0 ± 4.1	-9.9 ± 5.2	-19.5 ± 4.1	-59.0 ± 3.7	-54.8 ± 2.9	7.8 ± 3.8	2.4 ± 4.4	-69.2 ± 2.7	-73.3 ± 3.1	5.1 ± 3.2	-2.0 ± 4.7	-52.1 ± 2.3	-46.7 ± 3.3	-4.5 ± 5.3	-0.6 ± 6.6	-83.5 ± 4.6	-72.5 ± 5.2

Statistical analysis

A10 PBO Q2W vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -85.5 · 95% CI -95.2 to -75.9The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 PBO QM vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -75.8 · 95% CI -86.8 to -64.9The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (Q2W) vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -46.8 · 95% CI -56.6 to -37.1The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (QM) vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -51.7 · 95% CI -62.6 to -40.9The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO Q2W vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -71.7 · 95% CI -84.4 to -59.0The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO QM vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -61.8 · 95% CI -71.6 to -52.0The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (Q2W) vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -49.0 · 95% CI -61.5 to -36.6The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (QM) vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -35.3 · 95% CI -45.2 to -25.5The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO Q2W vs R5 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -77.1 · 95% CI -86.2 to -67.9The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO QM vs R5 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -75.8 · 95% CI -86.3 to -65.3The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO Q2W vs R40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -57.2 · 95% CI -65.1 to -49.4The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO QM vs R40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -44.6 · 95% CI -55.9 to -33.4The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO Q2W vs S40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -79.0 · 95% CI -87.5 to -70.4The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO QM vs S40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -71.9 · 95% CI -83.8 to -60.0The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit

SecondaryPercent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12

Time frame:: Baseline and Weeks 10 and 12
Reported as:: Least squares mean · percent change

Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12
percent change	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Percent Change From Baseline in Non-High-Density Lipoprotein Cholesterol (Non-HDL-C) at the Mean of Weeks 10 and 12	6.80 ± 2.07	1.28 ± 2.44	-20.71 ± 2.15	-16.56 ± 2.41	-53.48 ± 1.48	-56.09 ± 1.71	10.74 ± 3.59	8.45 ± 3.13	-16.19 ± 3.49	-18.79 ± 3.16	-54.44 ± 2.49	-56.31 ± 2.23	7.02 ± 2.11	3.73 ± 2.32	-52.59 ± 1.54	-55.47 ± 1.64	6.19 ± 2.61	1.58 ± 2.90	-52.08 ± 1.88	-55.72 ± 2.01	0.74 ± 3.23	6.81 ± 4.35	-59.33 ± 2.79	-56.01 ± 3.49

Statistical analysis

A10 PBO Q2W vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -60.28 · 95% CI -65.29 to -55.27The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 PBO QM vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -57.37 · 95% CI -63.23 to -51.51The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (Q2W) vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -32.77 · 95% CI -37.84 to -27.70The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (QM) vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -39.53 · 95% CI -45.34 to -33.71The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO Q2W vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -65.17 · 95% CI -73.78 to -56.56The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO QM vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -64.76 · 95% CI -72.32 to -57.19The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (Q2W) vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -38.25 · 95% CI -46.68 to -29.81The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (QM) vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -37.52 · 95% CI -45.15 to -29.90The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO Q2W vs R5 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -59.61 · 95% CI -64.73 to -54.48The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO QM vs R5 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -59.20 · 95% CI -64.80 to -53.60The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO Q2W vs R40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -58.27 · 95% CI -64.60 to -51.94The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO QM vs R40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -57.31 · 95% CI -64.29 to -50.32The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO Q2W vs S40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -60.06 · 95% CI -65.18 to -54.94The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO QM vs S40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -62.82 · 95% CI -70.22 to -55.42The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit

SecondaryPercent Change From Baseline in Non-HDL-C at Week 12

Time frame:: Baseline and Week 12
Reported as:: Least squares mean · percent change

Percent Change From Baseline in Non-HDL-C at Week 12
percent change	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Percent Change From Baseline in Non-HDL-C at Week 12	8.25 ± 2.32	2.43 ± 2.69	-18.27 ± 2.40	-14.78 ± 2.65	-53.39 ± 1.66	-52.20 ± 1.90	11.79 ± 3.87	9.95 ± 3.51	-14.34 ± 3.75	-17.26 ± 3.52	-54.84 ± 2.66	-50.05 ± 2.50	7.92 ± 2.40	5.85 ± 2.42	-52.04 ± 1.74	-51.57 ± 1.72	8.61 ± 3.04	3.35 ± 3.53	-50.97 ± 2.18	-46.42 ± 2.45	1.89 ± 3.38	5.66 ± 4.53	-59.02 ± 2.87	-50.96 ± 3.60

Statistical analysis

A10 PBO Q2W vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -61.64 · 95% CI -67.25 to -56.03The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 PBO QM vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -54.93 · 95% CI -61.40 to -48.46The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (Q2W) vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -35.11 · 95% CI -40.79 to -29.44The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (QM) vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -37.72 · 95% CI -44.15 to -31.30The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO Q2W vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -66.64 · 95% CI -75.88 to -57.39The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO QM vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -60.01 · 95% CI -68.49 to -51.52The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (Q2W) vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -40.51 · 95% CI -49.55 to -31.47The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (QM) vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -32.79 · 95% CI -41.30 to -24.28The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO Q2W vs R5 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -59.96 · 95% CI -65.78 to -54.13The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO QM vs R5 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -57.42 · 95% CI -63.27 to -51.57The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO Q2W vs R40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -59.58 · 95% CI -66.95 to -52.21The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO QM vs R40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -49.76 · 95% CI -58.26 to -41.27The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO Q2W vs S40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -60.91 · 95% CI -66.57 to -55.24The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO QM vs S40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -56.63 · 95% CI -64.63 to -48.62The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit

SecondaryPercent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12

Time frame:: Baseline and Weeks 10 and 12
Reported as:: Least squares mean · percent change

Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12
percent change	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12	7.55 ± 1.89	0.81 ± 2.19	-17.29 ± 2.00	-11.43 ± 2.20	-50.95 ± 1.38	-51.44 ± 1.52	10.20 ± 3.02	5.48 ± 2.83	-14.22 ± 2.98	-13.62 ± 2.87	-49.14 ± 2.13	-53.26 ± 2.02	5.07 ± 1.97	2.54 ± 1.89	-49.79 ± 1.46	-53.59 ± 1.32	3.71 ± 2.46	1.98 ± 2.57	-47.07 ± 1.76	-52.95 ± 1.76	-0.31 ± 3.02	2.49 ± 4.67	-55.65 ± 2.63	-54.37 ± 3.93

Statistical analysis

A10 PBO Q2W vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -58.49 · 95% CI -63.10 to -53.89The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 PBO QM vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -52.25 · 95% CI -57.49 to -47.01The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (Q2W) vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -33.66 · 95% CI -38.33 to -28.98The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (QM) vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -40.01 · 95% CI -45.27 to -34.74The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO Q2W vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -59.34 · 95% CI -66.61 to -52.07The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO QM vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -58.74 · 95% CI -65.56 to -51.93The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (Q2W) vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -34.92 · 95% CI -42.09 to -27.75The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (QM) vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -39.64 · 95% CI -46.57 to -32.71The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO Q2W vs R5 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -54.86 · 95% CI -59.66 to -50.05The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO QM vs R5 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -56.14 · 95% CI -60.66 to -51.61The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO Q2W vs R40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -50.78 · 95% CI -56.72 to -44.83The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO QM vs R40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -54.94 · 95% CI -61.11 to -48.76The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO Q2W vs S40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -55.34 · 95% CI -59.94 to -50.74The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO QM vs S40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -56.87 · 95% CI -63.27 to -50.46The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit

SecondaryPercent Change From Baseline in Apolipoprotein B at Week 12

Time frame:: Baseline and Week 12
Reported as:: Least squares mean · percent change

Percent Change From Baseline in Apolipoprotein B at Week 12
percent change	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Percent Change From Baseline in Apolipoprotein B at Week 12	7.89 ± 2.16	0.21 ± 2.43	-15.98 ± 2.26	-10.95 ± 2.44	-50.90 ± 1.56	-47.15 ± 1.70	11.64 ± 3.28	6.54 ± 3.22	-12.31 ± 3.20	-12.16 ± 3.24	-49.77 ± 2.28	-46.47 ± 2.31	6.35 ± 2.10	4.63 ± 2.11	-50.15 ± 1.54	-48.58 ± 1.49	4.91 ± 2.71	3.24 ± 3.13	-45.61 ± 1.93	-43.71 ± 2.13	0.35 ± 3.17	3.57 ± 4.74	-55.95 ± 2.72	-49.16 ± 3.97

Statistical analysis

A10 PBO Q2W vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -58.79 · 95% CI -64.03 to -53.55The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 PBO QM vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -47.36 · 95% CI -53.20 to -41.52The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (Q2W) vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -34.92 · 95% CI -40.23 to -29.60The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (QM) vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -36.21 · 95% CI -42.06 to -30.35The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO Q2W vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -61.40 · 95% CI -69.27 to -53.54The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO QM vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -53.01 · 95% CI -60.77 to -45.25The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (Q2W) vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -37.45 · 95% CI -45.17 to -29.74The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (QM) vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -34.31 · 95% CI -42.15 to -26.47The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO Q2W vs R5 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -56.50 · 95% CI -61.60 to -51.40The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO QM vs R5 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -53.21 · 95% CI -58.29 to -48.13The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO Q2W vs R40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -50.52 · 95% CI -57.06 to -43.99The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO QM vs R40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -46.95 · 95% CI -54.43 to -39.47The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO Q2W vs S40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -56.30 · 95% CI -61.47 to -51.14The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO QM vs S40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -52.73 · 95% CI -59.40 to -46.06The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit

SecondaryPercent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12

Time frame:: Baseline and Weeks 10 and 12
Reported as:: Least squares mean · percent change

Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12
percent change	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 12	5.96 ± 1.76	2.24 ± 2.11	-14.39 ± 1.83	-10.86 ± 2.08	-40.44 ± 1.26	-42.45 ± 1.48	4.26 ± 2.59	6.42 ± 2.34	-11.92 ± 2.52	-12.25 ± 2.35	-40.22 ± 1.80	-40.43 ± 1.66	5.41 ± 1.96	5.02 ± 2.25	-39.33 ± 1.43	-42.00 ± 1.59	4.55 ± 1.98	1.71 ± 2.36	-36.04 ± 1.42	-38.62 ± 1.64	-0.14 ± 2.79	5.45 ± 3.50	-47.20 ± 2.37	-43.17 ± 2.85

Statistical analysis

A10 PBO Q2W vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -46.41 · 95% CI -50.66 to -42.15The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 PBO QM vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -44.69 · 95% CI -49.75 to -39.63The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (Q2W) vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -26.06 · 95% CI -30.36 to -21.75The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (QM) vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -31.59 · 95% CI -36.61 to -26.57The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO Q2W vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -44.48 · 95% CI -50.69 to -38.27The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO QM vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -46.85 · 95% CI -52.48 to -41.21The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (Q2W) vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -28.30 · 95% CI -34.39 to -22.21The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (QM) vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -28.18 · 95% CI -33.86 to -22.50The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO Q2W vs R5 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -44.73 · 95% CI -49.50 to -39.97The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO QM vs R5 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -47.01 · 95% CI -52.46 to -41.57The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO Q2W vs R40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -40.59 · 95% CI -45.38 to -35.79The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO QM vs R40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -40.33 · 95% CI -46.00 to -34.66The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO Q2W vs S40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -47.05 · 95% CI -51.76 to -42.35The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO QM vs S40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -48.62 · 95% CI -54.27 to -42.98The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit

SecondaryPercent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12

Time frame:: Baseline and Week 12
Reported as:: Least squares mean · percent change

Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12
percent change	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12	6.09 ± 2.02	2.80 ± 2.31	-12.14 ± 2.10	-9.85 ± 2.28	-40.74 ± 1.45	-40.07 ± 1.63	4.31 ± 2.75	6.18 ± 2.73	-10.53 ± 2.66	-11.06 ± 2.73	-40.79 ± 1.89	-36.25 ± 1.94	4.68 ± 2.28	6.07 ± 2.36	-38.57 ± 1.64	-39.26 ± 1.68	5.96 ± 2.28	2.69 ± 2.80	-35.17 ± 1.63	-32.30 ± 1.94	-0.20 ± 2.81	5.13 ± 3.62	-47.24 ± 2.38	-39.47 ± 2.92

Statistical analysis

A10 PBO Q2W vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -46.83 · 95% CI -51.73 to -41.94The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 PBO QM vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -42.86 · 95% CI -48.43 to -37.30The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (Q2W) vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -28.60 · 95% CI -33.56 to -23.65The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (QM) vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -30.22 · 95% CI -35.74 to -24.70The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO Q2W vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -45.10 · 95% CI -51.66 to -38.54The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO QM vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -42.43 · 95% CI -49.01 to -35.85The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (Q2W) vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -30.26 · 95% CI -36.68 to -23.84The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (QM) vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -25.19 · 95% CI -31.79 to -18.59The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO Q2W vs R5 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -43.25 · 95% CI -48.77 to -37.74The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO QM vs R5 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -45.33 · 95% CI -51.04 to -39.61The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO Q2W vs R40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -41.13 · 95% CI -46.65 to -35.61The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO QM vs R40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -34.99 · 95% CI -41.72 to -28.25The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO Q2W vs S40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -47.04 · 95% CI -51.83 to -42.25The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO QM vs S40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -44.60 · 95% CI -50.67 to -38.54The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit

SecondaryPercent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12

Time frame:: Baseline and Weeks 10 and 12
Reported as:: Least squares mean · percent change

Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12
percent change	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at the Mean of Weeks 10 and 12	6.41 ± 2.03	0.78 ± 2.29	-15.77 ± 2.14	-11.47 ± 2.29	-53.56 ± 1.48	-53.33 ± 1.58	4.48 ± 3.04	5.79 ± 2.79	-15.17 ± 2.99	-12.91 ± 2.80	-52.43 ± 2.14	-56.20 ± 1.98	2.82 ± 2.26	2.58 ± 2.05	-52.46 ± 1.67	-56.66 ± 1.43	2.17 ± 2.56	2.60 ± 2.97	-48.47 ± 1.83	-54.17 ± 2.04	-1.00 ± 3.12	-1.42 ± 4.22	-58.76 ± 2.73	-57.47 ± 3.55

Statistical analysis

A10 PBO Q2W vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -59.97 · 95% CI -64.91 to -55.03The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 PBO QM vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -54.11 · 95% CI -59.57 to -48.64The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (Q2W) vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -37.79 · 95% CI -42.80 to -32.77The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (QM) vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -41.86 · 95% CI -47.34 to -36.67The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO Q2W vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -56.90 · 95% CI -64.22 to -49.59The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO QM vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -61.99 · 95% CI -68.68 to -55.29The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (Q2W) vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -37.26 · 95% CI -44.48 to -30.04The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (QM) vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -43.29 · 95% CI -50.07 to -36.51The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO Q2W vs R5 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -55.29 · 95% CI -60.79 to -49.79The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO QM vs R5 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -59.24 · 95% CI -64.16 to -54.32The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO Q2W vs R40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -50.63 · 95% CI -56.82 to -44.45The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO QM vs R40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -56.78 · 95% CI -63.91 to -49.64The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO Q2W vs S40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -57.75 · 95% CI -62.51 to -52.99The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO QM vs S40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -56.06 · 95% CI -61.85 to -50.27The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit

SecondaryPercent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12

Time frame:: Baseline and Week 12
Reported as:: Least squares mean · percent change

Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12
percent change	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A1 Ratio at Week 12	6.13 ± 2.20	-1.21 ± 2.41	-14.51 ± 2.31	-12.33 ± 2.41	-54.17 ± 1.59	-49.65 ± 1.69	4.19 ± 3.25	6.50 ± 3.18	-13.69 ± 3.17	-12.19 ± 3.17	-53.59 ± 2.26	-50.76 ± 2.26	1.44 ± 2.30	4.00 ± 2.27	-52.97 ± 1.69	-52.13 ± 1.60	1.64 ± 2.75	3.16 ± 3.51	-47.53 ± 1.96	-45.65 ± 2.39	-1.80 ± 3.21	-0.52 ± 4.29	-59.53 ± 2.77	-52.56 ± 3.59

Statistical analysis

A10 PBO Q2W vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -60.29 · 95% CI -65.65 to -54.94The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 PBO QM vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -48.44 · 95% CI -54.23 to -42.65The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (Q2W) vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -39.66 · 95% CI -45.09 to -34.23The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (QM) vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -37.32 · 95% CI -43.12 to -31.52The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO Q2W vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -57.77 · 95% CI -65.55 to -49.99The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO QM vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -57.26 · 95% CI -64.91 to -49.60The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (Q2W) vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -39.90 · 95% CI -47.53 to -32.26The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (QM) vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -38.57 · 95% CI -46.26 to -30.88The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO Q2W vs R5 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -54.41 · 95% CI -59.99 to -48.82The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO QM vs R5 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -56.13 · 95% CI -61.58 to -50.68The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO Q2W vs R40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -49.17 · 95% CI -55.80 to -42.53The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO QM vs R40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -48.81 · 95% CI -57.21 to -40.40The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO Q2W vs S40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -57.73 · 95% CI -62.82 to -52.65The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO QM vs S40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -52.04 · 95% CI -58.10 to -45.98The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit

SecondaryPercentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL

Time frame:: Weeks 10 and 12
Reported as:: Number · percentage of participants

Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL
percentage of participants	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL	5.7 (1.9 to 15.4)	5.6 (1.9 to 15.1)	20.0 (11.2 to 33.0)	16.7 (9.0 to 28.7)	88.1 (80.7 to 92.9)	85.8 (78.0 to 91.2)	13.7 (6.8 to 25.7)	9.3 (4.0 to 19.9)	50.9 (38.1 to 63.6)	62.3 (48.8 to 74.1)	94.4 (88.4 to 97.4)	92.5 (85.9 to 96.2)	7.0 (2.8 to 16.7)	5.3 (1.8 to 14.4)	88.7 (81.2 to 93.4)	89.9 (82.8 to 94.3)	38.9 (27.0 to 52.2)	28.8 (18.3 to 42.3)	93.5 (87.1 to 96.8)	94.5 (88.6 to 97.5)	1.9 (0.3 to 9.8)	3.9 (1.1 to 13.2)	93.6 (87.3 to 96.9)	88.5 (81.3 to 93.2)

Statistical analysis

A10 PBO Q2W vs A10 EvoMab Q2W · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 82.4 · 95% CI 70.2 to 88.5Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)
A10 PBO QM vs A10 EvoMab QM · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 80.3 · 95% CI 67.9 to 86.8Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
A10 EZE (Q2W) vs A10 EvoMab Q2W · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 68.1 · 95% CI 53.1 to 78.1Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
A10 EZE (QM) vs A10 EvoMab QM · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 69.2 · 95% CI 54.8 to 78.5Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)
A80 PBO Q2W vs A80 EvoMab Q2W · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 80.7 · 95% CI 67.3 to 88.3Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
A80 PBO QM vs A80 EvoMab QM · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 83.3 · 95% CI 70.7 to 89.6Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)
A80 EZE (Q2W) vs A80 EvoMab Q2W · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 43.5 · 95% CI 29.5 to 56.7Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
A80 EZE (QM) vs A80 EvoMab QM · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 30.3 · 95% CI 16.7 to 44.2Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
R5 PBO Q2W vs R5 EvoMab Q2W · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 81.7 · 95% CI 69.5 to 88.0Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
R5 PBO QM vs R5 EvoMab QM · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 84.6 · 95% CI 73.1 to 90.2Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
R40 PBO Q2W vs R40 EvoMab Q2W · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 54.6 · 95% CI 39.8 to 66.9Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
R40 PBO QM vs R40 EvoMab QM · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 65.7 · 95% CI 51.0 to 76.6Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
S40 PBO Q2W vs S40 EvoMab Q2W · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 91.7 · 95% CI 81.6 to 95.3Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
S40 PBO QM vs S40 EvoMab QM · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 84.6 · 95% CI 72.8 to 90.0Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).

SecondaryPercentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12

Time frame:: Week 12
Reported as:: Number · percentage of participants

Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12
percentage of participants	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12	2.0 (0.3 to 10.3)	5.9 (2.0 to 15.9)	22.4 (13.0 to 35.9)	19.2 (10.8 to 31.9)	85.4 (77.4 to 91.0)	84.2 (75.8 to 90.0)	13.0 (6.1 to 25.7)	9.8 (4.3 to 21.0)	52.0 (38.5 to 65.2)	55.8 (42.3 to 68.4)	93.1 (86.5 to 96.6)	91.0 (83.8 to 95.2)	7.7 (3.0 to 18.2)	5.5 (1.9 to 14.9)	85.0 (76.7 to 90.7)	86.5 (78.7 to 91.8)	39.6 (27.6 to 53.1)	28.0 (17.5 to 41.7)	92.3 (85.6 to 96.1)	92.3 (85.6 to 96.1)	1.9 (0.3 to 10.1)	6.4 (2.2 to 17.2)	94.4 (88.4 to 97.4)	84.8 (76.7 to 90.4)

Statistical analysis

A10 PBO Q2W vs A10 EvoMab Q2W · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 83.5 · 95% CI 71.9 to 89.2Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)
A10 PBO QM vs A10 EvoMab QM · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 78.3 · 95% CI 65.2 to 85.3Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
A10 EZE (Q2W) vs A10 EvoMab Q2W · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 63.0 · 95% CI 47.3 to 73.9Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
A10 EZE (QM) vs A10 EvoMab QM · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 64.9 · 95% CI 49.8 to 75.2Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)
A80 PBO Q2W vs A80 EvoMab Q2W · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 80.1 · 95% CI 65.8 to 87.9Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
A80 PBO QM vs A80 EvoMab QM · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 81.2 · 95% CI 67.9 to 88.1Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage)
A80 EZE (Q2W) vs A80 EvoMab Q2W · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 41.1 · 95% CI 26.4 to 55.1Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
A80 EZE (QM) vs A80 EvoMab QM · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 35.2 · 95% CI 20.7 to 49.3Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
R5 PBO Q2W vs R5 EvoMab Q2W · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 77.3 · 95% CI 63.9 to 84.7Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
R5 PBO QM vs R5 EvoMab QM · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 81.1 · 95% CI 68.8 to 87.5Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
R40 PBO Q2W vs R40 EvoMab Q2W · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 52.7 · 95% CI 37.6 to 65.3Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
R40 PBO QM vs R40 EvoMab QM · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 64.3 · 95% CI 49.1 to 75.5Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
S40 PBO Q2W vs S40 EvoMab Q2W · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 92.5 · 95% CI 82.3 to 95.9Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).
S40 PBO QM vs S40 EvoMab QM · Cochran-Mantel-Haenszel · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Treatment difference: 78.4 · 95% CI 64.9 to 85.4Based on Cochran-Mantel Haenszel test stratified by the stratification factors (entry statin therapy and simvastatin contraindicated therapy usage).

SecondaryPercent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12

Time frame:: Baseline and Weeks 10 and 12
Reported as:: Least squares mean · percent change

Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12
percent change	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 12	6.07 ± 2.86	-0.77 ± 3.28	1.44 ± 3.02	6.85 ± 3.29	-26.01 ± 2.08	-22.64 ± 2.27	-3.45 ± 2.99	1.51 ± 3.35	8.05 ± 2.94	9.96 ± 3.40	-23.97 ± 2.10	-27.46 ± 2.39	11.41 ± 3.00	3.65 ± 3.56	-24.26 ± 2.21	-23.16 ± 2.50	8.59 ± 2.98	6.26 ± 3.59	-24.96 ± 2.12	-25.93 ± 2.46	-10.57 ± 4.49	-4.99 ± 5.37	-38.64 ± 3.92	-32.16 ± 4.50

Statistical analysis

A10 PBO Q2W vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -32.08 · 95% CI -39.06 to -25.11The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 PBO QM vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -21.86 · 95% CI -29.70 to -14.03The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (Q2W) vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -27.45 · 95% CI -34.53 to -20.38The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (QM) vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -29.49 · 95% CI -37.36 to -21.62The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO Q2W vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -20.52 · 95% CI -27.71 to -13.33The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO QM vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -28.96 · 95% CI -37.01 to -20.92The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (Q2W) vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -32.02 · 95% CI -39.11 to -24.93The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (QM) vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -37.42 · 95% CI -45.61 to -29.23The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO Q2W vs R5 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -35.66 · 95% CI -42.94 to -28.38The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO QM vs R5 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -26.81 · 95% CI -35.36 to -18.27The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO Q2W vs R40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -33.56 · 95% CI -40.74 to -26.37The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO QM vs R40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -32.19 · 95% CI -40.80 to -23.58The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO Q2W vs S40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -28.07 · 95% CI -34.91 to -21.23The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO QM vs S40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -27.16 · 95% CI -34.59 to -19.73The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit

SecondaryPercent Change From Baseline in Lipoprotein(a) at Week 12

Time frame:: Baseline and Week 12
Reported as:: Least squares mean · percent change

Percent Change From Baseline in Lipoprotein(a) at Week 12
percent change	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Percent Change From Baseline in Lipoprotein(a) at Week 12	7.34 ± 3.13	-0.43 ± 3.38	3.29 ± 3.28	7.18 ± 3.38	-25.87 ± 2.26	-20.25 ± 2.36	-2.23 ± 3.35	3.41 ± 3.54	8.01 ± 3.26	10.20 ± 3.57	-24.61 ± 2.31	-24.68 ± 2.53	11.40 ± 3.37	4.49 ± 3.68	-25.09 ± 2.47	-20.85 ± 2.59	10.38 ± 3.09	10.21 ± 4.36	-26.11 ± 2.21	-21.97 ± 2.97	-6.81 ± 4.57	-1.06 ± 5.67	-38.06 ± 3.96	-29.23 ± 4.68

Statistical analysis

A10 PBO Q2W vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -33.20 · 95% CI -40.81 to -25.60The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 PBO QM vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -19.82 · 95% CI -27.92 to -11.72The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (Q2W) vs A10 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -29.16 · 95% CI -36.87 to -21.44The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (QM) vs A10 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -27.44 · 95% CI -35.56 to -19.32The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO Q2W vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -22.38 · 95% CI -30.39 to -14.36The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO QM vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -28.10 · 95% CI -36.62 to -19.58The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (Q2W) vs A80 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -32.62 · 95% CI -40.46 to -24.78The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (QM) vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -34.88 · 95% CI -43.52 to -26.25The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO Q2W vs R5 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -36.50 · 95% CI -44.69 to -28.30The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO QM vs R5 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -25.34 · 95% CI -34.19 to -16.49The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO Q2W vs R40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -36.48 · 95% CI -43.95 to -29.02The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO QM vs R40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -32.17 · 95% CI -42.61 to -21.74The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO Q2W vs S40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -31.25 · 95% CI -38.40 to -24.10The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO QM vs S40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -28.17 · 95% CI -36.79 to -19.55The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit

SecondaryPercent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12

Time frame:: Baseline and Weeks 10 and 12
Reported as:: Least squares mean · percent change

Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12
percent change	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12	6.49 ± 3.94	9.17 ± 4.41	-3.16 ± 4.10	1.57 ± 4.35	-5.61 ± 2.81	-13.38 ± 3.08	6.16 ± 4.02	8.05 ± 4.35	-8.10 ± 3.92	-4.86 ± 4.39	-9.27 ± 2.80	-6.36 ± 3.11	12.43 ± 4.19	12.26 ± 4.67	-10.28 ± 3.04	-7.26 ± 3.29	8.44 ± 3.76	10.75 ± 3.98	-9.15 ± 2.70	-15.43 ± 2.77	9.29 ± 6.97	13.78 ± 7.44	-11.67 ± 5.97	-15.93 ± 6.15

Statistical analysis

A10 PBO Q2W vs A10 EvoMab Q2W · Repeated measures linear effects model · p = 0.20 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -12.10 · 95% CI -21.63 to -2.58The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 PBO QM vs A10 EvoMab QM · Repeated measures linear effects model · p = 0.003 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -22.55 · 95% CI -33.13 to -11.97The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (Q2W) vs A10 EvoMab Q2W · Repeated measures linear effects model · p = 1.00 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -2.45 · 95% CI -12.09 to 7.19The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (QM) vs A10 EvoMab QM · Repeated measures linear effects model · p = 0.053 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -14.95 · 95% CI -25.46 to -4.44The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO Q2W vs A80 EvoMab Q2W · Repeated measures linear effects model · p = 0.073 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -15.43 · 95% CI -25.06 to -5.79The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO QM vs A80 EvoMab QM · Repeated measures linear effects model · p = 0.027 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -14.41 · 95% CI -24.90 to -3.92The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (Q2W) vs A80 EvoMab Q2W · Repeated measures linear effects model · p = 1.00 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -1.17 · 95% CI -10.63 to 8.30The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (QM) vs A80 EvoMab QM · Repeated measures linear effects model · p = 0.63 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -1.51 · 95% CI -12.12 to 9.11The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO Q2W vs R5 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -22.72 · 95% CI -32.90 to -12.54The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO QM vs R5 EvoMab QM · Repeated measures linear effects model · p = 0.007 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -19.52 · 95% CI -30.76 to -8.28The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO Q2W vs R40 EvoMab Q2W · Repeated measures linear effects model · p = 0.002 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -17.59 · 95% CI -26.71 to -8.46The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO QM vs R40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -26.18 · 95% CI -35.76 to -16.59The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO Q2W vs S40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -20.97 · 95% CI -32.38 to -9.55The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO QM vs S40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -29.71 · 95% CI -40.84 to -18.57The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit

SecondaryPercent Change From Baseline in Triglycerides at Week 12

Time frame:: Baseline and Week 12
Reported as:: Least squares mean · percent change

Percent Change From Baseline in Triglycerides at Week 12
percent change	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Percent Change From Baseline in Triglycerides at Week 12	8.27 ± 5.23	14.35 ± 5.92	-0.43 ± 5.39	4.88 ± 5.84	-3.79 ± 3.72	-13.26 ± 4.17	6.65 ± 4.45	8.22 ± 5.22	-7.40 ± 4.32	-3.11 ± 5.23	-10.07 ± 3.05	-1.10 ± 3.74	13.57 ± 5.76	12.96 ± 5.32	-4.46 ± 4.16	-6.88 ± 3.80	10.97 ± 4.66	10.00 ± 4.38	-5.58 ± 3.34	-10.51 ± 3.04	8.07 ± 6.88	16.72 ± 7.88	-13.71 ± 5.91	-14.65 ± 6.39

Statistical analysis

A10 PBO Q2W vs A10 EvoMab Q2W · Repeated measures linear effects model · p = 0.20 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -12.06 · 95% CI -24.69 to 0.57The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 PBO QM vs A10 EvoMab QM · Repeated measures linear effects model · p = 0.003 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -27.60 · 95% CI -41.86 to -13.35The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (Q2W) vs A10 EvoMab Q2W · Repeated measures linear effects model · p = 1.00 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -3.37 · 95% CI -16.16 to 9.43The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (QM) vs A10 EvoMab QM · Repeated measures linear effects model · p = 0.053 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -18.13 · 95% CI -32.28 to -3.99The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO Q2W vs A80 EvoMab Q2W · Repeated measures linear effects model · p = 0.073 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -16.72 · 95% CI -27.34 to -6.10The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO QM vs A80 EvoMab QM · Repeated measures linear effects model · p = 0.027 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -9.31 · 95% CI -21.92 to 3.29The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (Q2W) vs A80 EvoMab Q2W · Repeated measures linear effects model · p = 1.00 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -2.67 · 95% CI -13.05 to 7.72The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (QM) vs A80 EvoMab QM · Repeated measures linear effects model · p = 0.63 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 2.02 · 95% CI -10.66 to 14.69The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO Q2W vs R5 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -18.03 · 95% CI -32.03 to -4.04The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO QM vs R5 EvoMab QM · Repeated measures linear effects model · p = 0.007 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -19.83 · 95% CI -32.71 to -6.96The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO Q2W vs R40 EvoMab Q2W · Repeated measures linear effects model · p = 0.002 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -16.55 · 95% CI -27.84 to -5.26The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO QM vs R40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -20.51 · 95% CI -31.04 to -9.98The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO Q2W vs S40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -21.78 · 95% CI -32.88 to -10.68The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO QM vs S40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -31.36 · 95% CI -44.10 to -18.62The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit

SecondaryPercent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12

Time frame:: Baseline and Weeks 10 and 12
Reported as:: Least squares mean · percent change

Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12
percent change	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at the Mean of Weeks 10 and 12	6.51 ± 3.56	9.53 ± 4.45	-5.35 ± 3.74	1.77 ± 4.41	-6.85 ± 2.56	-11.77 ± 3.11	6.24 ± 4.03	8.31 ± 4.26	-8.52 ± 3.93	-6.13 ± 4.31	-8.96 ± 2.82	-6.38 ± 3.05	12.86 ± 3.95	12.54 ± 4.58	-12.22 ± 2.86	-7.25 ± 3.23	7.06 ± 3.76	8.13 ± 3.72	-9.09 ± 2.71	-15.05 ± 2.58	8.64 ± 6.01	16.37 ± 7.15	-14.57 ± 5.17	-16.50 ± 5.87

Statistical analysis

A10 PBO Q2W vs A10 EvoMab Q2W · Repeated measures linear effects model · p = 0.088 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -13.36 · 95% CI -21.99 to -4.74The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 PBO QM vs A10 EvoMab QM · Repeated measures linear effects model · p = 0.005 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -21.31 · 95% CI -31.98 to -10.64The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (Q2W) vs A10 EvoMab Q2W · Repeated measures linear effects model · p = 1.00 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -1.50 · 95% CI -10.27 to 7.27The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (QM) vs A10 EvoMab QM · Repeated measures linear effects model · p = 0.056 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -13.54 · 95% CI -24.17 to -2.91The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO Q2W vs A80 EvoMab Q2W · Repeated measures linear effects model · p = 0.073 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -15.21 · 95% CI -24.88 to -5.54The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO QM vs A80 EvoMab QM · Repeated measures linear effects model · p = 0.027 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -14.69 · 95% CI -24.97 to -4.42The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (Q2W) vs A80 EvoMab Q2W · Repeated measures linear effects model · p = 1.00 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -0.44 · 95% CI -9.94 to 9.05The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (QM) vs A80 EvoMab QM · Repeated measures linear effects model · p = 0.62 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -0.25 · 95% CI -10.66 to 10.16The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO Q2W vs R5 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -25.07 · 95% CI -34.64 to -15.50The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO QM vs R5 EvoMab QM · Repeated measures linear effects model · p = 0.007 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -19.79 · 95% CI -30.81 to -8.77The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO Q2W vs R40 EvoMab Q2W · Repeated measures linear effects model · p = 0.005 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -16.15 · 95% CI -25.27 to -7.03The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO QM vs R40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -23.18 · 95% CI -32.11 to -14.25The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO Q2W vs S40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -23.21 · 95% CI -33.00 to -13.43The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO QM vs S40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -32.87 · 95% CI -43.60 to -22.14The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit

SecondaryPercent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12

Time frame:: Baseline and Week 12
Reported as:: Least squares mean · percent change

Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12
percent change	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Percent Change From Baseline in Very Low-Density Cholesterol (VLDL-C) at Week 12	8.32 ± 4.00	14.74 ± 5.91	-4.61 ± 4.19	3.45 ± 5.89	-6.16 ± 2.88	-11.73 ± 4.16	6.73 ± 4.45	8.54 ± 5.00	-7.92 ± 4.32	-6.00 ± 5.04	-9.69 ± 3.05	-1.06 ± 3.58	13.79 ± 5.05	12.47 ± 5.31	-8.20 ± 3.64	-6.28 ± 3.78	10.09 ± 4.65	8.59 ± 4.37	-6.10 ± 3.33	-9.95 ± 3.03	7.63 ± 6.26	20.97 ± 7.53	-14.83 ± 5.30	-15.86 ± 6.09

Statistical analysis

A10 PBO Q2W vs A10 EvoMab Q2W · Repeated measures linear effects model · p = 0.088 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -14.47 · 95% CI -24.16 to -4.78The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 PBO QM vs A10 EvoMab QM · Repeated measures linear effects model · p = 0.005 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -26.47 · 95% CI -40.71 to -12.24The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (Q2W) vs A10 EvoMab Q2W · Repeated measures linear effects model · p = 1.00 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -1.54 · 95% CI -11.41 to 8.32The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (QM) vs A10 EvoMab QM · Repeated measures linear effects model · p = 0.056 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -15.19 · 95% CI -29.40 to -0.97The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO Q2W vs A80 EvoMab Q2W · Repeated measures linear effects model · p = 0.073 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -16.42 · 95% CI -27.05 to -5.80The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO QM vs A80 EvoMab QM · Repeated measures linear effects model · p = 0.027 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -9.60 · 95% CI -21.68 to 2.48The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (Q2W) vs A80 EvoMab Q2W · Repeated measures linear effects model · p = 1.00 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -1.78 · 95% CI -12.16 to 8.61The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (QM) vs A80 EvoMab QM · Repeated measures linear effects model · p = 0.62 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 4.94 · 95% CI -7.25 to 17.14The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO Q2W vs R5 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -21.98 · 95% CI -34.24 to -9.73The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO QM vs R5 EvoMab QM · Repeated measures linear effects model · p = 0.007 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -18.75 · 95% CI -31.60 to -5.90The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO Q2W vs R40 EvoMab Q2W · Repeated measures linear effects model · p = 0.005 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -16.19 · 95% CI -27.46 to -4.92The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO QM vs R40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -18.54 · 95% CI -29.04 to -8.05The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO Q2W vs S40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -22.45 · 95% CI -33.09 to -11.81The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO QM vs S40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: -36.83 · 95% CI -48.96 to -24.70The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit

SecondaryPercent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12

Time frame:: Baseline and Weeks 10 and 12
Reported as:: Least squares mean · percent change

Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12
percent change	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12	-0.99 ± 1.50	-0.45 ± 1.94	-1.13 ± 1.56	-0.92 ± 1.92	5.54 ± 1.07	7.66 ± 1.37	4.48 ± 1.73	-1.37 ± 1.85	0.86 ± 1.68	-0.59 ± 1.86	8.44 ± 1.20	7.76 ± 1.31	0.87 ± 1.52	-0.94 ± 2.55	6.23 ± 1.10	7.72 ± 1.80	-0.60 ± 1.56	-0.40 ± 1.81	4.86 ± 1.12	6.35 ± 1.26	0.13 ± 2.75	-2.14 ± 2.72	10.35 ± 2.26	6.71 ± 2.25

Statistical analysis

A10 PBO Q2W vs A10 EvoMab Q2W · Repeated measures linear effects model · p = 0.034 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 6.53 · 95% CI 2.91 to 10.15The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 PBO QM vs A10 EvoMab QM · Repeated measures linear effects model · p = 0.017 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 8.11 · 95% CI 3.43 to 12.79The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (Q2W) vs A10 EvoMab Q2W · Repeated measures linear effects model · p = 0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 6.67 · 95% CI 3.00 to 10.34The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (QM) vs A10 EvoMab QM · Repeated measures linear effects model · p = 0.006 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 8.57 · 95% CI 3.93 to 13.22The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO Q2W vs A80 EvoMab Q2W · Repeated measures linear effects model · p = 0.85 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 3.95 · 95% CI -0.19 to 8.09The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO QM vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 9.13 · 95% CI 4.68 to 13.58The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (Q2W) vs A80 EvoMab Q2W · Repeated measures linear effects model · p = 0.003 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 7.57 · 95% CI 3.51 to 11.64The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (QM) vs A80 EvoMab QM · Repeated measures linear effects model · p = 0.003 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 8.35 · 95% CI 3.86 to 12.84The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO Q2W vs R5 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 5.36 · 95% CI 1.68 to 9.04The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO QM vs R5 EvoMab QM · Repeated measures linear effects model · p = 0.010 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 8.66 · 95% CI 2.51 to 14.80The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO Q2W vs R40 EvoMab Q2W · Repeated measures linear effects model · p = 0.013 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 5.46 · 95% CI 1.69 to 9.23The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO QM vs R40 EvoMab QM · Repeated measures linear effects model · p = 0.002 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 6.75 · 95% CI 2.40 to 11.10The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO Q2W vs S40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 10.23 · 95% CI 5.13 to 15.32The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO QM vs S40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 8.85 · 95% CI 4.73 to 12.97The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit

SecondaryPercent Change From Baseline in HDL-C at Week 12

Time frame:: Baseline and Week 12
Reported as:: Least squares mean · percent change

Percent Change From Baseline in HDL-C at Week 12
percent change	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Percent Change From Baseline in HDL-C at Week 12	0.22 ± 1.72	0.01 ± 2.02	-1.76 ± 1.78	-0.40 ± 1.99	7.04 ± 1.23	7.88 ± 1.42	5.02 ± 1.88	0.30 ± 2.01	0.62 ± 1.83	0.21 ± 2.01	9.09 ± 1.29	7.36 ± 1.43	2.87 ± 1.87	-0.16 ± 2.64	6.07 ± 1.35	7.18 ± 1.87	-0.39 ± 1.86	0.73 ± 1.98	4.65 ± 1.34	5.57 ± 1.37	1.14 ± 2.96	-2.65 ± 2.87	10.92 ± 2.38	6.41 ± 2.34

Statistical analysis

A10 PBO Q2W vs A10 EvoMab Q2W · Repeated measures linear effects model · p = 0.034 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 6.83 · 95% CI 2.66 to 10.99The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 PBO QM vs A10 EvoMab QM · Repeated measures linear effects model · p = 0.017 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 7.87 · 95% CI 3.01 to 12.73The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (Q2W) vs A10 EvoMab Q2W · Repeated measures linear effects model · p = 0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 8.81 · 95% CI 4.58 to 13.03The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A10 EZE (QM) vs A10 EvoMab QM · Repeated measures linear effects model · p = 0.006 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 8.28 · 95% CI 3.46 to 13.11The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO Q2W vs A80 EvoMab Q2W · Repeated measures linear effects model · p = 0.85 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 4.07 · 95% CI -0.42 to 8.57The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 PBO QM vs A80 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 7.05 · 95% CI 2.22 to 11.89The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (Q2W) vs A80 EvoMab Q2W · Repeated measures linear effects model · p = 0.003 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 8.47 · 95% CI 4.07 to 12.87The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
A80 EZE (QM) vs A80 EvoMab QM · Repeated measures linear effects model · p = 0.003 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 7.14 · 95% CI 2.29 to 11.99The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO Q2W vs R5 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 3.20 · 95% CI -1.33 to 7.73The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R5 PBO QM vs R5 EvoMab QM · Repeated measures linear effects model · p = 0.010 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 7.35 · 95% CI 0.97 to 13.72The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO Q2W vs R40 EvoMab Q2W · Repeated measures linear effects model · p = 0.013 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 5.04 · 95% CI 0.52 to 9.56The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
R40 PBO QM vs R40 EvoMab QM · Repeated measures linear effects model · p = 0.002 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 4.84 · 95% CI 0.07 to 9.60The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO Q2W vs S40 EvoMab Q2W · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 9.78 · 95% CI 4.05 to 15.51The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit.
S40 PBO QM vs S40 EvoMab QM · Repeated measures linear effects model · p = <0.001 (Multiplicity adjusted p-value is significant if less than the familywise error rate of 0.05.) · Ls mean treatment difference: 9.06 · 95% CI 4.40 to 13.72The model included treatment group, stratification factors, scheduled visit and the interaction of treatment with scheduled visit

Adverse events

Collected over From the first dose of blinded investigational product until the end of the study (up to 14 weeks).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
A10 PBO Q2W	—	1/56 (1.8%)	5/56 (8.9%)
A10 PBO QM	—	2/55 (3.6%)	3/55 (5.5%)
A10 EZE (Q2W)	—	0/56 (0%)	9/56 (16.1%)
A10 EZE (QM)	—	0/55 (0%)	6/55 (10.9%)
A10 EvoMab Q2W	—	4/110 (3.6%)	9/110 (8.2%)
A10 EvoMab QM	—	2/110 (1.8%)	7/110 (6.4%)
A80 PBO Q2W	—	2/55 (3.6%)	7/55 (12.7%)
A80 PBO QM	—	1/55 (1.8%)	13/55 (23.6%)
A80 EZE (Q2W)	—	1/56 (1.8%)	8/56 (14.3%)
A80 EZE (QM)	—	1/54 (1.9%)	2/54 (3.7%)
A80 EvoMab Q2W	—	3/109 (2.8%)	11/109 (10.1%)
A80 EvoMab QM	—	1/110 (0.9%)	9/110 (8.2%)
R5 PBO Q2W	—	1/58 (1.7%)	11/58 (19%)
R5 PBO QM	—	2/57 (3.5%)	1/57 (1.8%)
R5 EvoMab Q2W	—	3/113 (2.7%)	6/113 (5.3%)
R5 EvoMab QM	—	3/115 (2.6%)	9/115 (7.8%)
R40 PBO Q2W	—	2/56 (3.6%)	3/56 (5.4%)
R40 PBO QM	—	1/55 (1.8%)	8/55 (14.5%)
R40 EvoMab Q2W	—	1/111 (0.9%)	5/111 (4.5%)
R40 EvoMab QM	—	3/112 (2.7%)	8/112 (7.1%)
S40 PBO Q2W	—	0/56 (0%)	3/56 (5.4%)
S40 PBO QM	—	1/55 (1.8%)	5/55 (9.1%)
S40 EvoMab Q2W	—	2/112 (1.8%)	18/112 (16.1%)
S40 EvoMab QM	—	1/115 (0.9%)	11/115 (9.6%)

Most frequent serious events

Showing 10 of 43

Most frequent serious events
Event	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Troponin increasedInvestigations	0/56	0/55	0/56	0/55	0/110	0/110	0/55	0/55	0/56	1/54	0/109	0/110	0/58	0/57	0/113	0/115	0/56	0/55	0/111	0/112	0/56	0/55	0/112	0/115
Hypertensive crisisVascular disorders	0/56	0/55	0/56	0/55	0/110	0/110	0/55	0/55	0/56	1/54	0/109	0/110	0/58	0/57	0/113	0/115	0/56	0/55	0/111	0/112	0/56	0/55	0/112	0/115
Gastrointestinal haemorrhageGastrointestinal disorders	0/56	0/55	0/56	0/55	0/110	0/110	1/55	0/55	0/56	0/54	0/109	0/110	0/58	0/57	0/113	0/115	0/56	1/55	0/111	0/112	0/56	0/55	0/112	0/115
Drug-induced liver injuryHepatobiliary disorders	0/56	1/55	0/56	0/55	0/110	0/110	0/55	0/55	0/56	0/54	0/109	0/110	0/58	0/57	0/113	0/115	0/56	0/55	0/111	0/112	0/56	0/55	0/112	0/115
GastroenteritisInfections and infestations	0/56	0/55	0/56	0/55	0/110	0/110	1/55	0/55	0/56	0/54	0/109	0/110	0/58	0/57	0/113	0/115	0/56	0/55	0/111	0/112	0/56	0/55	0/112	0/115
Herpes simplex meningoencephalitisInfections and infestations	0/56	0/55	0/56	0/55	0/110	0/110	1/55	0/55	0/56	0/54	0/109	0/110	0/58	0/57	0/113	0/115	0/56	0/55	0/111	0/112	0/56	0/55	0/112	0/115
Pneumonia mycoplasmalInfections and infestations	0/56	1/55	0/56	0/55	0/110	0/110	0/55	0/55	0/56	0/54	0/109	0/110	0/58	0/57	0/113	0/115	0/56	0/55	0/111	0/112	0/56	0/55	0/112	0/115
MyalgiaMusculoskeletal and connective tissue disorders	0/56	0/55	0/56	0/55	0/110	0/110	0/55	1/55	0/56	0/54	0/109	0/110	0/58	0/57	0/113	0/115	0/56	0/55	0/111	0/112	0/56	0/55	0/112	0/115
Grand mal convulsionNervous system disorders	0/56	0/55	0/56	0/55	0/110	0/110	1/55	0/55	0/56	0/54	0/109	0/110	0/58	0/57	0/113	0/115	0/56	0/55	0/111	0/112	0/56	0/55	0/112	0/115
Peripheral artery stenosisVascular disorders	0/56	0/55	0/56	0/55	0/110	0/110	0/55	0/55	0/56	0/54	0/109	0/110	0/58	0/57	0/113	0/115	0/56	0/55	0/111	0/112	0/56	1/55	0/112	0/115

Most frequent other events

Most frequent other events
Event	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM
Back painMusculoskeletal and connective tissue disorders	0/56	0/55	3/56	1/55	2/110	1/110	2/55	2/55	2/56	1/54	3/109	0/110	4/58	0/57	1/113	2/115	0/56	5/55	2/111	1/112	0/56	1/55	6/112	2/115
DiarrhoeaGastrointestinal disorders	0/56	0/55	0/56	1/55	2/110	0/110	1/55	4/55	1/56	0/54	4/109	2/110	0/58	1/57	0/113	2/115	1/56	1/55	0/111	1/112	0/56	1/55	1/112	0/115
HeadacheNervous system disorders	1/56	1/55	1/56	4/55	1/110	0/110	2/55	2/55	0/56	0/54	1/109	3/110	3/58	0/57	1/113	1/115	2/56	1/55	2/111	3/112	2/56	1/55	2/112	5/115
MyalgiaMusculoskeletal and connective tissue disorders	2/56	2/55	2/56	0/55	0/110	1/110	0/55	3/55	1/56	1/54	1/109	2/110	1/58	0/57	0/113	2/115	0/56	1/55	1/111	1/112	0/56	1/55	1/112	3/115
ConstipationGastrointestinal disorders	3/56	0/55	0/56	0/55	0/110	0/110	1/55	0/55	1/56	0/54	0/109	0/110	0/58	0/57	1/113	0/115	0/56	0/55	0/111	0/112	0/56	0/55	2/112	0/115
Muscle spasmsMusculoskeletal and connective tissue disorders	0/56	0/55	1/56	2/55	3/110	4/110	1/55	2/55	3/56	0/54	2/109	1/110	1/58	0/57	2/113	0/115	0/56	1/55	0/111	1/112	0/56	1/55	3/112	1/115
DizzinessNervous system disorders	0/56	0/55	2/56	1/55	1/110	1/110	1/55	1/55	1/56	1/54	0/109	1/110	3/58	0/57	1/113	2/115	0/56	0/55	0/111	1/112	1/56	0/55	3/112	1/115

Baseline characteristics

Age, Continuous
Age, Continuous(years)	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM	Total
Mean	58.3 ± 10.5	62.2 ± 10.4	61.0 ± 9.0	60.6 ± 9.2	58.3 ± 8.4	59.6 ± 11.1	57.1 ± 9.9	58.8 ± 11.5	60.5 ± 10.2	61.1 ± 8.9	59.7 ± 10.2	60.1 ± 10.2	61.2 ± 9.1	59.6 ± 9.2	58.9 ± 11.2	59.3 ± 10.5	60.2 ± 8.7	58.3 ± 11.3	59.5 ± 9.2	59.6 ± 9.0	61.9 ± 9.7	61.5 ± 10.3	59.7 ± 9.2	61.5 ± 9.6	59.8 ± 9.9

Sex: Female, Male
Sex: Female, Male(Participants)	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM	Total
Female	24	28	29	28	56	44	22	24	24	28	44	48	35	27	52	51	21	27	43	52	32	28	45	59	871
Male	32	27	27	27	54	66	33	31	32	26	66	62	23	30	62	64	35	29	68	60	24	27	67	56	1028

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM	Total
Hispanic or Latino	3	2	2	1	5	2	5	5	4	4	5	7	2	4	6	3	2	3	6	5	1	2	3	5	87
Not Hispanic or Latino	53	53	54	54	105	108	50	50	52	50	105	103	56	53	108	112	54	53	105	107	55	53	109	110	1812

Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM	Total
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1
Asian	1	0	2	1	3	4	1	0	0	3	1	1	0	0	2	1	1	0	0	0	3	0	1	0	25
Black or African American	3	0	1	2	9	4	1	2	3	4	3	4	2	1	7	5	0	3	5	3	3	1	4	5	75
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	1	0	0	0	0	1	0	0	0	4
White	52	55	53	52	97	101	51	52	53	46	105	105	56	56	104	107	55	52	105	109	49	54	106	110	1785
Other	0	0	0	0	1	0	2	0	0	0	1	0	0	0	1	1	0	1	0	0	0	0	0	0	7
Mixed Race	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	2

Stratification Factor: Entry Statin Therapy
Stratification Factor: Entry Statin Therapy(participants)	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM	Total
Intensive statin use	18	19	10	14	28	35	15	12	21	11	34	35	13	13	33	38	13	13	33	37	19	13	31	34	542
Non-intensive statin use	20	25	30	21	52	40	22	27	22	21	47	46	25	28	49	42	23	22	50	44	21	26	45	48	796
No statin use	18	11	16	20	30	35	18	16	13	22	29	29	20	16	32	35	20	21	28	31	16	16	36	33	561

Low-Density Lipoprotein Cholesterol (LDL-C) Concentration
Low-Density Lipoprotein Cholesterol (LDL-C) Concentration(mg/dL)	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM	Total
Mean	123.0 ± 46.6	123.7 ± 47.9	126.8 ± 49.6	119.3 ± 28.1	124.2 ± 43.4	126.1 ± 50.4	100.3 ± 36.2	94.7 ± 31.9	98.7 ± 34.0	92.3 ± 19.3	94.2 ± 34.8	93.8 ± 32.3	115.6 ± 39.8	119.9 ± 39.1	118.7 ± 40.9	122.9 ± 42.0	77.4 ± 20.9	102.9 ± 49.3	88.5 ± 31.5	88.5 ± 31.3	110.3 ± 28.0	108.6 ± 30.9	114.9 ± 34.5	123.7 ± 48.5	109.1 ± 41.1

Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration
Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration(mg/dL)	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM	Total
Mean	149.1 ± 46.9	147.7 ± 51.4	153.8 ± 53.2	148.3 ± 36.8	152.3 ± 45.6	154.3 ± 53.1	124.2 ± 39.3	116.5 ± 35.7	124.8 ± 35.4	118.4 ± 25.5	120.2 ± 42.3	117.2 ± 36.3	141.1 ± 41.6	148.3 ± 43.3	146.6 ± 43.2	152.0 ± 46.4	103.9 ± 25.7	128.7 ± 53.4	113.5 ± 36.0	114.3 ± 34.7	138.4 ± 29.3	135.7 ± 38.4	146.8 ± 41.8	151.2 ± 51.5	150.3 ± 27.6

Apolipoprotein B Concentration
Apolipoprotein B Concentration(mg/dL)	A10 PBO Q2W	A10 PBO QM	A10 EZE (Q2W)	A10 EZE (QM)	A10 EvoMab Q2W	A10 EvoMab QM	A80 PBO Q2W	A80 PBO QM	A80 EZE (Q2W)	A80 EZE (QM)	A80 EvoMab Q2W	A80 EvoMab QM	R5 PBO Q2W	R5 PBO QM	R5 EvoMab Q2W	R5 EvoMab QM	R40 PBO Q2W	R40 PBO QM	R40 EvoMab Q2W	R40 EvoMab QM	S40 PBO Q2W	S40 PBO QM	S40 EvoMab Q2W	S40 EvoMab QM	Total
Mean	95.3 ± 26.0	95.3 ± 29.6	101.3 ± 31.2	94.6 ± 20.4	99.7 ± 26.4	97.3 ± 28.9	81.1 ± 22.1	80.1 ± 21.4	85.3 ± 23.1	78.7 ± 16.9	79.9 ± 25.1	77.9 ± 21.5	93.1 ± 27.3	95.9 ± 25.2	95.4 ± 27.0	97.2 ± 26.9	71.0 ± 16.6	84.8 ± 29.7	77.4 ± 22.3	78.7 ± 23.1	91.6 ± 18.4	89.8 ± 20.7	94.2 ± 24.0	96.5 ± 27.5	89.1 ± 26.1

6 further baseline measures are reported on the registry.

Study locations

244 sites

Research Site
Birmingham, Alabama 35294, United States
Research Site
Glendale, Arizona 85306, United States
Research Site
Tucson, Arizona 85710, United States
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Tucson, Arizona 85712, United States
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Carmichael, California 95608, United States
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Encino, California 91436, United States
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Long Beach, California 90822, United States
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Newport Beach, California 92663, United States
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San Diego, California 92123, United States
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Santa Ana, California 92705, United States
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Santa Rosa, California 95405, United States
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Thousand Oaks, California 91360, United States
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Torrance, California 90509, United States
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Tustin, California 92780, United States
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Westlake Village, California 91361, United States
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Littleton, Colorado 80120, United States
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Daytona Beach, Florida 32117, United States
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Jacksonville, Florida 32223, United States
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Melbourne, Florida 32901, United States
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Miami, Florida 33173, United States
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Port Charlotte, Florida 33952, United States
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Atlanta, Georgia 30328, United States
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Atlanta, Georgia 30342, United States
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Boise, Idaho 83704, United States
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Hammond, Indiana 46320, United States
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Indianapolis, Indiana 46237, United States
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Valparaiso, Indiana 46383, United States
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Iowa City, Iowa 52242, United States
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Crestview Hills, Kentucky 41017, United States
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Monroe, Louisiana 71203, United States
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Auburn, Maine 04210, United States
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Bangor, Maine 04401, United States
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Portland, Maine 04101, United States
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Baltimore, Maryland 21201, United States
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Ypsilanti, Michigan 48197, United States
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Tupelo, Mississippi 38801, United States
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Billings, Montana 59102, United States
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Voorhees, New Jersey 08043, United States
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Manlius, New York 13104, United States
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Rochester, New York 14609, United States
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Syracuse, New York 13210, United States
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Williamsville, New York 14221, United States
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Winston-Salem, North Carolina 27103, United States
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Cadiz, Ohio 43907, United States
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Canton, Ohio 44708, United States
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Cincinnati, Ohio 45219, United States
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Cincinnati, Ohio 45227, United States
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Dayton, Ohio 45414, United States
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Mansfield, Ohio 44906, United States
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Marion, Ohio 43302, United States
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Sandusky, Ohio 44870, United States
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Norman, Oklahoma 73069, United States
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Duncansville, Pennsylvania 16635, United States
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Pittsburgh, Pennsylvania 15216, United States
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York, Pennsylvania 17405, United States
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Florence, South Carolina 29501, United States
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Rapid City, South Dakota 57701, United States
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Jackson, Tennessee 38301, United States
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Jackson, Tennessee 38305, United States
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Dallas, Texas 75231, United States
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Houston, Texas 77074, United States
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San Antonio, Texas 78229, United States
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Suffolk, Virginia 23435, United States
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Winchester, Virginia 22601, United States
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Tacoma, Washington 98405, United States
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Sydney, New South Wales 2022, Australia
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Ashford, South Australia 5035, Australia
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Fullarton, South Australia 5063, Australia
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Fitzroy, Victoria 3065, Australia
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Heidelberg Heights, Victoria 3081, Australia
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Richmond, Victoria 3121, Australia
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Blankenberge, 8370, Belgium
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Hasselt, 3500, Belgium
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Oostende, 8400, Belgium
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Tremelo, 3120, Belgium
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Vilvoorde, 1800, Belgium
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Burnaby, British Columbia V5G 1T4, Canada
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Kelowna, British Columbia V1Y 1E4, Canada
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Kelowna, British Columbia V1Y 1V6, Canada
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Surrey, British Columbia V3V 1N1, Canada
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Saint Johnâ€™s, Newfoundland and Labrador A1A 3R5, Canada
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Cambridge, Ontario N1R 6V6, Canada
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Hamilton, Ontario L8L 2X2, Canada
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London, Ontario N5W 6A2, Canada
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Newmarket, Ontario L3Y 5G8, Canada
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Oshawa, Ontario L1J 2K1, Canada
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Sarnia, Ontario N7T 4X3, Canada
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Scarborough, Ontario M1P 2T7, Canada
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Toronto, Ontario M8V 3X8, Canada
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Toronto, Ontario M9V 4B4, Canada
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Woodstock, Ontario N4S 5P5, Canada
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Brossard, Quebec J4X 1S4, Canada
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Greenfield Park, Quebec J4V 2G8, Canada
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Lachine, Quebec H8S 2E4, Canada
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Longueuil, Quebec J4N 0C9, Canada
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Montreal, Quebec H4N 2W2, Canada
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Pointe-Claire, Quebec H9R 3J1, Canada
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Brno, 602 00, Czechia
Research Site
Brno, 603 00, Czechia

Showing the first 100 of 244 sites across 21 countries.

References and documents

Publications

Robinson JG, Nedergaard BS, Rogers WJ, Fialkow J, Neutel JM, Ramstad D, Somaratne R, Legg JC, Nelson P, Scott R, Wasserman SM, Weiss R; LAPLACE-2 Investigators. Effect of evolocumab or ezetimibe added to moderate- or high-intensity statin therapy on LDL-C lowering in patients with hypercholesterolemia: the LAPLACE-2 randomized clinical trial. JAMA. 2014 May 14;311(18):1870-82. doi: 10.1001/jama.2014.4030. PubMed 24825642 ↗
Robinson JG, Rogers WJ, Nedergaard BS, Fialkow J, Neutel JM, Ramstad D, Somaratne R, Legg JC, Nelson P, Scott R, Wasserman SM, Weiss R. Rationale and design of LAPLACE-2: a phase 3, randomized, double-blind, placebo- and ezetimibe-controlled trial evaluating the efficacy and safety of evolocumab in subjects with hypercholesterolemia on background statin therapy. Clin Cardiol. 2014 Apr;37(4):195-203. doi: 10.1002/clc.22252. Epub 2014 Jan 30. PubMed 24481874 ↗
Daviglus ML, Ferdinand KC, Lopez JAG, Wu Y, Monsalvo ML, Rodriguez CJ. Effects of Evolocumab on Low-Density Lipoprotein Cholesterol, Non-High Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a) by Race and Ethnicity: A Meta-Analysis of Individual Participant Data From Double-Blind and Open-Label Extension Studies. J Am Heart Assoc. 2021 Jan 5;10(1):e016839. doi: 10.1161/JAHA.120.016839. Epub 2020 Dec 16. PubMed 33325247 ↗
Koren MJ, Jones PH, Robinson JG, Sullivan D, Cho L, Hucko T, Lopez JAG, Fleishman AN, Somaratne R, Stroes E. A Comparison of Ezetimibe and Evolocumab for Atherogenic Lipid Reduction in Four Patient Populations: A Pooled Efficacy and Safety Analysis of Three Phase 3 Studies. Cardiol Ther. 2020 Dec;9(2):447-465. doi: 10.1007/s40119-020-00181-8. Epub 2020 Jun 20. PubMed 32564340 ↗
Kuchimanchi M, Grover A, Emery MG, Somaratne R, Wasserman SM, Gibbs JP, Doshi S. Population pharmacokinetics and exposure-response modeling and simulation for evolocumab in healthy volunteers and patients with hypercholesterolemia. J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):505-522. doi: 10.1007/s10928-018-9592-y. Epub 2018 May 7. PubMed 29736889 ↗
Kasichayanula S, Grover A, Emery MG, Gibbs MA, Somaratne R, Wasserman SM, Gibbs JP. Clinical Pharmacokinetics and Pharmacodynamics of Evolocumab, a PCSK9 Inhibitor. Clin Pharmacokinet. 2018 Jul;57(7):769-779. doi: 10.1007/s40262-017-0620-7. PubMed 29353350 ↗
Shapiro MD, Minnier J, Tavori H, Kassahun H, Flower A, Somaratne R, Fazio S. Relationship Between Low-Density Lipoprotein Cholesterol and Lipoprotein(a) Lowering in Response to PCSK9 Inhibition With Evolocumab. J Am Heart Assoc. 2019 Feb 19;8(4):e010932. doi: 10.1161/JAHA.118.010932. PubMed 30755061 ↗
Stroes E, Robinson JG, Raal FJ, Dufour R, Sullivan D, Kassahun H, Ma Y, Wasserman SM, Koren MJ. Consistent LDL-C response with evolocumab among patient subgroups in PROFICIO: A pooled analysis of 3146 patients from phase 3 studies. Clin Cardiol. 2018 Oct;41(10):1328-1335. doi: 10.1002/clc.23049. Epub 2018 Oct 21. PubMed 30120772 ↗
Toth PP, Descamps O, Genest J, Sattar N, Preiss D, Dent R, Djedjos C, Wu Y, Geller M, Uhart M, Somaratne R, Wasserman SM; PROFICIO Investigators. Pooled Safety Analysis of Evolocumab in Over 6000 Patients From Double-Blind and Open-Label Extension Studies. Circulation. 2017 May 9;135(19):1819-1831. doi: 10.1161/CIRCULATIONAHA.116.025233. Epub 2017 Mar 1. PubMed 28249876 ↗
Toth PP, Jones SR, Monsalvo ML, Elliott-Davey M, Lopez JAG, Banach M. Effect of Evolocumab on Non-High-Density Lipoprotein Cholesterol, Apolipoprotein B, and Lipoprotein(a): A Pooled Analysis of Phase 2 and Phase 3 Studies. J Am Heart Assoc. 2020 Mar 3;9(5):e014129. doi: 10.1161/JAHA.119.014129. Epub 2020 Mar 2. PubMed 32114889 ↗
Wasserman SM, Sabatine MS, Koren MJ, Giugliano RP, Legg JC, Emery MG, Doshi S, Liu T, Somaratne R, Gibbs JP. Comparison of LDL-C Reduction Using Different Evolocumab Doses and Intervals: Biological Insights and Treatment Implications. J Cardiovasc Pharmacol Ther. 2018 Sep;23(5):423-432. doi: 10.1177/1074248418774043. Epub 2018 May 16. PubMed 29768954 ↗
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Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01763866
Lead sponsor: Amgen
Responsible party: Sponsor
First posted: Jan 9, 2013
Start date: Jan 15, 2013
Primary completion: Nov 12, 2013
Completion: Dec 4, 2013
Results posted: Dec 22, 2015
Last update: Nov 8, 2022

Study contacts

study director · Amgen

Oversight

Data monitoring committee: Yes

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