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CompletedNCT01953328AMG145Updated Dec 23, 2015Results posted

Study of Low-Density Lipoprotein Cholesterol (LDL-C) Reduction Using Evolocumab (AMG 145) in Japanese Patients With Advanced Cardiovascular Risk

A Phase 3 interventional study of Atorvastatin and Evolocumab in Hyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular Events, sponsored by Amgen. Completed at 54 sites in Japan. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-12-23.

Sponsored by Amgen · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
409
Allocation
Randomized
Ages
20 Years to 85 Years
Sex
All
01

Study summary

The primary objective of the study was to evaluate the effect of 12 weeks of subcutaneous evolocumab administered every 2 weeks and once a month, compared with placebo, on percent change from baseline in LDL-C when used in combination with statin therapy in adults with high cardiovascular risk and with hyperlipidemia or mixed dyslipidemia.

Read the detailed description

After a screening and placebo run-in period, eligible patients were randomized in a 1:1 ratio to 1 of 2 open-label background statin treatments (atorvastatin 5 mg or 20 mg daily [QD]) and entered a 4-week lipid stabilization period. After the lipid stabilization period, eligible patients were randomized in a 1:1:1:1 ratio to investigational product (evolocumab or placebo) for the 12-week treatment period.

Both randomizations were stratified by subject diagnosis and lipid-lowering therapy as follows:

  • current or prior diagnosis of heterozygous familial hypercholesterolemia (HeFH)
  • no diagnosis of HeFH and receiving intensive lipid-lowering therapy
  • no diagnosis of HeFH and receiving non-intensive lipid-lowering therapy. A participant was considered randomized into the study after successfully completing the screening period, meeting all inclusion/exclusion criteria including meeting final laboratory safety criteria, and undergoing both randomization procedures.
02

Conditions studied

  • Hyperlipidemia or Mixed Dyslipidemia at High Risk for Cardiovascular Events

Keywords

  • Japanese, high cholesterol, LDL-C, High Cardiovascular Risk
03

In context

Hyperlipidemias

839 studies on the registry are indexed under Hyperlipidemias; 107 are open to participants now.

This study's enrollment of 409 is above the median of 88 across 707 interventional studies indexed under Hyperlipidemias.

Browse Hyperlipidemias studies →

Lead sponsor

Amgen is the lead sponsor of 1,044 studies on the registry; 51 are open to participants now.

Of its 246 completed or terminated interventional studies of FDA-regulated products, 164 (67%) have results posted.

Browse Amgen studies →

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

04

Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: Male or female, Japanese adult, 20-85 years of age; Subjects on stable dose of statin for greater than equal to 4 weeks; Fasting LDL-C greater than equal to 100 mg/dL; Fasting triglycerides less than equal to 400 mg/dL; Subject is at high risk for cardiovascular events. Exclusion Criteria: New York heart Association (NYHA) III or IV - heart failure; Uncontrolled cardiac arrhythmia; Uncontrolled hypertension; Type 1 diabetes, poorly controlled type 2 diabetes; Uncontrolled hypothyroidism or hyperthyroidism

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
409 participants (actual)

Study arms

  • Placebo comparator
    A5 Placebo Q2W

    Participants received atorvastatin 5 mg (A5) once daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.

    Drug: Atorvastatin · Other: Placebo to Evolocumab

  • Placebo comparator
    A5 Placebo QM

    Participants received atorvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.

    Drug: Atorvastatin · Other: Placebo to Evolocumab

  • Experimental
    A5 Evolocumab Q2W

    Participants received atorvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.

    Drug: Atorvastatin · Biological: Evolocumab

  • Experimental
    A5 Evolocumab QM

    Participants received atorvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.

    Drug: Atorvastatin · Biological: Evolocumab

  • Placebo comparator
    A20 Placebo Q2W

    Participants received atorvastatin 20 mg (A20) once daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.

    Drug: Atorvastatin · Other: Placebo to Evolocumab

  • Other
    A20 Placebo QM

    Participants received atorvastatin 20 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.

    Drug: Atorvastatin · Other: Placebo to Evolocumab

  • Experimental
    A20 Evolocumab Q2W

    Participants received atorvastatin 20 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.

    Drug: Atorvastatin · Biological: Evolocumab

  • Experimental
    A20 Evolocumab QM

    Participants received atorvastatin 20 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.

    Drug: Atorvastatin · Biological: Evolocumab

Interventions

  • DrugAtorvastatin

    Administered orally once a day

    Also known as: Lipitor

  • BiologicalEvolocumab

    Administered by subcutaneous injection

    Also known as: AMG 145, Repatha

  • OtherPlacebo to Evolocumab

    Administered by subcutaneous injection

06

What researchers measure

Primary outcomes

  1. Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

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

    Time frame: Baseline and Week 12

Secondary outcomes

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

    Time frame: Baseline and Weeks 10 and 12

  2. Change From Baseline in LDL-C at Week 12

    Time frame: Baseline and Week 12

  3. Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  4. Percent Change From Baseline in Non-HDL-C at Week 12

    Time frame: Baseline and Week 12

  5. Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  6. Percent Change From Baseline in Apolipoprotein B at Week 12

    Time frame: Baseline and Week 12

  7. Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  8. Percent Change From Baseline in Total Cholesterol at Week 12

    Time frame: Baseline and Week 12

  9. 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

  10. Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 12

    Time frame: Baseline and Week 12

  11. Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  12. Percent Change From Baseline in the Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12

    Time frame: Baseline and Week 12

  13. 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

  14. Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 12

    Time frame: Week 12

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

    Time frame: Baseline and Weeks 10 and 12

  16. Percent Change From Baseline in Lipoprotein(a) at Week 12

    Time frame: Baseline and Week 12

  17. Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  18. Percent Change From Baseline in Triglycerides at Week 12

    Time frame: Baseline and Week 12

  19. Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  20. Percent Change From Baseline in HDL-C at Week 12

    Time frame: Baseline and Week 12

  21. Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 12

    Time frame: Baseline and Weeks 10 and 12

  22. Percent Change From Baseline in VLDL-C at Week 12

    Time frame: Baseline and Week 12

07

Results

Posted Dec 23, 2015

Participant flow

Japanese men and women ≥ 20 to ≤ 85 years of age, with fasting low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL (2.6 mmol/L), fasting triglycerides ≤ 400 mg/dL (4.5 mmol/L), and at high risk for cardiovascular events were eligible to participate. First patient enrolled on 07 October 2013 and last patient enrolled on 17 February 2014.

Participant flow — Overall Study
MilestoneA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Started4950505052515151
Received treatment4950505052515151
Completed4950505050515151
Not completed00002000
Withdrew: Withdrawal by subject00001000
Withdrew: Lost to follow-up00001000

Outcome measures

PrimaryPercent Change From Baseline in Low-Density Lipoprotein Cholesterol (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 Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 12
percent changeA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at the Mean of Weeks 10 and 120.27 ± 2.213.91 ± 2.09-73.70 ± 2.26-69.98 ± 2.02-0.42 ± 3.26-2.67 ± 2.31-74.82 ± 3.26-76.93 ± 2.24
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: -73.97 · 95% CI -78.54 to -69.41Placebo is the reference
  • A5 Placebo QM vs A5 Evolocumab 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: -72.89 · 95% CI -77.22 to -68.57Placebo is the reference
  • A20 Placebo Q2W vs A20 Evolocumab 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: -74.41 · 95% CI -81.21 to -67.61Placebo is the reference
  • A20 Placebo QM vs A20 Evolocumab 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: -74.27 · 95% CI -78.93 to -69.60Placebo is the reference
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 changeA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 121.28 ± 2.435.29 ± 2.19-73.57 ± 2.48-64.62 ± 2.121.39 ± 3.51-3.49 ± 2.67-74.46 ± 3.50-70.36 ± 2.61
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: -74.85 · 95% CI -80.22 to -69.47Placebo is the reference
  • A5 Placebo QM vs A5 Evolocumab 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: -69.91 · 95% CI -74.60 to -65.23Placebo is the reference
  • A20 Placebo Q2W vs A20 Evolocumab 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: -78.85 · 95% CI -83.55 to -68.15Placebo is the reference
  • A20 Placebo QM vs A20 Evolocumab 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: -66.87 · 95% CI -72.88 to -60.87Placebo is the reference
SecondaryChange 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 · mg/dL
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12
mg/dLA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Change From Baseline in LDL-C at the Mean of Weeks 10 and 12-14.8 ± 4.3-2.6 ± 4.3-104.1 ± 4.4-88.9 ± 4.1-8.9 ± 3.2-5.7 ± 3.7-77.6 ± 3.2-77.7 ± 3.6
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: -89.3 · 95% CI -98.4 to -80.2Placebo is the reference
  • A5 Placebo QM vs A5 Evolocumab 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: -86.3 · 95% CI -95.1 to -77.5Placebo is the reference
  • A20 Placebo Q2W vs A20 Evolocumab 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: -68.7 · 95% CI -75.3 to -62.1Placebo is the reference
  • A20 Placebo QM vs A20 Evolocumab 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: -72.0 · 95% CI -79.5 to -64.6Placebo is the reference
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/dLA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Change From Baseline in LDL-C at Week 12-13.7 ± 4.6-0.4 ± 4.3-104.5 ± 4.6-84.0 ± 4.2-7.7 ± 3.3-6.2 ± 4.0-77.2 ± 3.3-71.7 ± 3.9
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: -90.8 · 95% CI -100.9 to -80.7Placebo is the reference
  • A5 Placebo QM vs A5 Evolocumab 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: -83.6 · 95% CI -92.5 to -74.8Placebo is the reference
  • A20 Placebo Q2W vs A20 Evolocumab 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: -69.6 · 95% CI -76.5 to -62.6Placebo is the reference
  • A20 Placebo QM vs A20 Evolocumab 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: -65.5 · 95% CI -73.8 to -57.1Placebo is the reference
SecondaryPercent Change From Baseline in 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-HDL-C at the Mean of Weeks 10 and 12
percent changeA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Percent Change From Baseline in Non-HDL-C at the Mean of Weeks 10 and 120.18 ± 2.134.26 ± 1.86-68.48 ± 2.18-61.69 ± 1.80-1.57 ± 2.45-1.79 ± 1.94-69.72 ± 2.45-69.07 ± 1.88
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: -68.67 · 95% CI -73.06 to -64.27Placebo is the reference
  • A5 Placebo QM vs A5 Evolocumab 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: -65.95 · 95% CI -69.74 to -62.16Placebo is the reference
  • A20 Placebo Q2W vs A20 Evolocumab 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: -68.14 · 95% CI -73.30 to -62.99Placebo is the reference
  • A20 Placebo QM vs A20 Evolocumab 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: -67.28 · 95% CI -71.14 to -63.42Placebo is the reference
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 changeA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Percent Change From Baseline in Non-HDL-C at Week 121.12 ± 2.305.55 ± 2.02-67.81 ± 2.35-58.03 ± 1.96-0.07 ± 2.68-2.38 ± 2.22-68.89 ± 2.67-63.27 ± 2.16
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: -68.93 · 95% CI -73.96 to -63.89Placebo is the reference
  • A5 Placebo QM vs A5 Evolocumab 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: -63.58 · 95% CI -67.96 to -59.21Placebo is the reference
  • A20 Placebo Q2W vs A20 Evolocumab 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: -68.82 · 95% CI -74.79 to -62.86Placebo is the reference
  • A20 Placebo QM vs A20 Evolocumab 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: -60.89 · 95% CI -65.78 to -55.99Placebo is the reference
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 changeA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Percent Change From Baseline in Apolipoprotein B at the Mean of Weeks 10 and 12-0.32 ± 1.980.76 ± 2.06-64.76 ± 2.03-58.47 ± 1.99-4.32 ± 2.27-0.85 ± 1.90-64.38 ± 2.27-64.24 ± 1.84
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: -64.44 · 95% CI -68.49 to -60.39Placebo is the reference
  • A5 Placebo QM vs A5 Evolocumab 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 -63.30 to -55.17Placebo is the reference
  • A20 Placebo Q2W vs A20 Evolocumab 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 -64.87 to -55.25Placebo is the reference
  • A20 Placebo QM vs A20 Evolocumab 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: -63.39 · 95% CI -67.15 to -59.62Placebo is the reference
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 changeA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Percent Change From Baseline in Apolipoprotein B at Week 120.74 ± 2.172.42 ± 2.26-64.83 ± 2.22-54.80 ± 2.19-2.47 ± 2.48-1.89 ± 2.17-62.83 ± 2.47-58.04 ± 2.11
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: -65.56 · 95% CI -70.34 to -60.79Placebo is the reference
  • A5 Placebo QM vs A5 Evolocumab 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: -57.23 · 95% CI -62.05 to -52.40Placebo is the reference
  • A20 Placebo Q2W vs A20 Evolocumab 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: -60.37 · 95% CI -65.91 to -54.83Placebo is the reference
  • A20 Placebo QM vs A20 Evolocumab 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: -56.15 · 95% CI -60.92 to -51.39Placebo is the reference
SecondaryPercent Change From Baseline in Total Cholesterol 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 Total Cholesterol at the Mean of Weeks 10 and 12
percent changeA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Percent Change From Baseline in Total Cholesterol at the Mean of Weeks 10 and 12-2.49 ± 1.811.09 ± 1.63-48.03 ± 1.85-42.34 ± 1.58-4.21 ± 1.86-2.35 ± 1.68-45.19 ± 1.86-45.49 ± 1.63
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: -45.54 · 95% CI -49.35 to -41.73Placebo is the reference
  • A5 Placebo QM vs A5 Evolocumab 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: -43.43 · 95% CI -46.78 to -40.08Placebo is the reference
  • A20 Placebo Q2W vs A20 Evolocumab 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: -40.98 · 95% CI -44.88 to -37.08Placebo is the reference
  • A20 Placebo QM vs A20 Evolocumab 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: -43.14 · 95% CI -46.48 to -39.80Placebo is the reference
SecondaryPercent Change From Baseline in Total Cholesterol at Week 12
Time frame:
Baseline and Week 12
Reported as:
Least squares mean · percent change
Percent Change From Baseline in Total Cholesterol at Week 12
percent changeA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Percent Change From Baseline in Total Cholesterol at Week 12-1.70 ± 1.972.29 ± 1.67-47.14 ± 2.01-39.06 ± 1.62-3.08 ± 2.00-2.44 ± 1.81-44.04 ± 1.99-40.88 ± 1.76
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: -45.44 · 95% CI -49.83 to -41.05Placebo is the reference
  • A5 Placebo QM vs A5 Evolocumab 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: -41.34 · 95% CI -44.84 to -37.85Placebo is the reference
  • A20 Placebo Q2W vs A20 Evolocumab 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: -40.96 · 95% CI -45.35 to -36.57Placebo is the reference
  • A20 Placebo QM vs A20 Evolocumab 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: -38.44 · 95% CI -42.26 to -34.62Placebo is the reference
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 changeA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at the Mean of Weeks 10 and 123.77 ± 2.113.94 ± 2.16-51.00 ± 2.16-48.71 ± 2.091.04 ± 1.821.58 ± 2.04-49.79 ± 1.81-48.11 ± 1.98
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: -54.77 · 95% CI -59.37 to -50.17Placebo is the reference
  • A5 Placebo QM vs A5 Evolocumab 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: -52.66 · 95% CI -56.95 to -48.36Placebo is the reference
  • A20 Placebo Q2W vs A20 Evolocumab 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: -50.83 · 95% CI -54.72 to -46.93Placebo is the reference
  • A20 Placebo QM vs A20 Evolocumab 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: -49.69 · 95% CI -53.74 to -45.64Placebo is the reference
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 changeA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Percent Change From Baseline in the Total Cholesterol/HDL-C Ratio at Week 124.73 ± 2.364.33 ± 2.33-50.72 ± 2.40-46.62 ± 2.261.84 ± 2.010.83 ± 2.20-49.52 ± 2.00-44.61 ± 2.13
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: -55.45 · 95% CI -60.93 to -49.98Placebo is the reference
  • A5 Placebo QM vs A5 Evolocumab 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: -50.95 · 95% CI -55.91 to -46.00Placebo is the reference
  • A20 Placebo Q2W vs A20 Evolocumab 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: -51.36 · 95% CI -55.93 to -46.80Placebo is the reference
  • A20 Placebo QM vs A20 Evolocumab 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: -45.44 · 95% CI -50.08 to -40.81Placebo is the reference
SecondaryPercent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 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 A-1 Ratio at the Mean of Weeks 10 and 12
percent changeA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at the Mean of Weeks 10 and 120.06 ± 2.022.79 ± 2.37-66.41 ± 2.07-61.55 ± 2.29-1.92 ± 2.301.54 ± 2.09-65.97 ± 2.30-65.72 ± 2.02
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: -66.47 · 95% CI -70.58 to -62.36Placebo is the reference
  • A5 Placebo QM vs A5 Evolocumab 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: -64.33 · 95% CI -69.01 to -59.66Placebo is the reference
  • A20 Placebo Q2W vs A20 Evolocumab 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: -64.05 · 95% CI -68.90 to -59.20Placebo is the reference
  • A20 Placebo QM vs A20 Evolocumab 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: -67.26 · 95% CI -71.36 to -63.15Placebo is the reference
SecondaryPercent Change From Baseline in the Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12
Time frame:
Baseline and Week 12
Reported as:
Least squares mean · percent change
Percent Change From Baseline in the Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12
percent changeA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Percent Change From Baseline in the Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 120.71 ± 2.114.08 ± 2.62-67.59 ± 2.16-58.45 ± 2.53-1.15 ± 2.470.06 ± 2.30-65.11 ± 2.46-60.56 ± 2.23
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: -68.29 · 95% CI -72.75 to -63.84Placebo is the reference
  • A5 Placebo QM vs A5 Evolocumab 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: -62.53 · 95% CI -68.11 to -56.94Placebo is the reference
  • A20 Placebo Q2W vs A20 Evolocumab 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: -63.97 · 95% CI -69.44 to -58.50Placebo is the reference
  • A20 Placebo QM vs A20 Evolocumab 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: -60.62 · 95% CI -65.51 to -55.72Placebo is the reference
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 participantsA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Percentage of Participants Who Achieved a Mean LDL-C at Weeks 10 and 12 of Less Than 70 mg/dL0.0 ± 2.020.0 ± 2.3798.0 ± 2.0796.0 ± 2.2922.4 ± 2.3015.7 ± 2.0996.0 ± 2.3098.0 ± 2.02
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: 98.0 · 95% CI 86.8 to 99.6Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).
  • A5 Placebo QM vs A5 Evolocumab 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: 96.0 · 95% CI 84.1 to 98.9Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).
  • A20 Placebo Q2W vs A20 Evolocumab 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: 73.6 · 95% CI 57.1 to 83.4Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).
  • A20 Placebo QM vs A20 Evolocumab 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: 82.4 · 95% CI 67.5 to 90.0Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).
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 participantsA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Percentage of Participants Who Achieved LDL-C < 70 mg/dL at Week 120.0 ± 2.024.2 ± 2.3798.0 ± 2.0796.0 ± 2.2920.4 ± 2.3020.0 ± 2.0996.0 ± 2.3098.0 ± 2.02
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: 98.0 · 95% CI 86.7 to 99.6Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).
  • A5 Placebo QM vs A5 Evolocumab 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: 91.8 · 95% CI 78.2 to 96.0Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).
  • A20 Placebo Q2W vs A20 Evolocumab 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: 75.6 · 95% CI 59.3 to 85.0Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).
  • A20 Placebo QM vs A20 Evolocumab 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: 78.0 · 95% CI 62.6 to 86.9Based on Cochran-Mantel Haenszel test stratified by the stratification factor (HeFH diagnosis and lipid-lowering therapy).
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 changeA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Percent Change From Baseline in Lipoprotein(a) at the Mean of Weeks 10 and 125.23 ± 6.184.07 ± 4.95-45.97 ± 6.27-45.01 ± 4.786.52 ± 4.81-5.62 ± 5.00-43.03 ± 4.81-49.55 ± 4.85
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: -51.20 · 95% CI -63.88 to -38.52Placebo is the reference
  • A5 Placebo QM vs A5 Evolocumab 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: -49.08 · 95% CI -58.89 to -39.27Placebo is the reference
  • A20 Placebo Q2W vs A20 Evolocumab 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: -49.55 · 95% CI -59.74 to -39.35Placebo is the reference
  • A20 Placebo QM vs A20 Evolocumab 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: -43.93 · 95% CI -53.75 to -34.12Placebo is the reference
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 changeA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Percent Change From Baseline in Lipoprotein(a) at Week 124.35 ± 6.867.03 ± 5.47-45.72 ± 6.93-41.74 ± 5.2910.75 ± 5.15-5.73 ± 5.18-41.93 ± 5.13-45.70 ± 5.02
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: -50.07 · 95% CI -65.25 to -34.90Placebo is the reference
  • A5 Placebo QM vs A5 Evolocumab 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: -48.77 · 95% CI -60.49 to -37.05Placebo is the reference
  • A20 Placebo Q2W vs A20 Evolocumab 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: -52.68 · 95% CI -64.06 to -41.30Placebo is the reference
  • A20 Placebo QM vs A20 Evolocumab 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: -39.97 · 95% CI -50.46 to -29.48Placebo is the reference
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 changeA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Percent Change From Baseline in Triglycerides at the Mean of Weeks 10 and 124.69 ± 6.044.54 ± 5.31-23.23 ± 6.15-17.41 ± 5.14-2.11 ± 4.458.06 ± 6.16-22.12 ± 4.44-12.66 ± 6.01
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: -27.93 · 95% CI -41.27 to -14.59Placebo is the reference
  • A5 Placebo QM vs A5 Evolocumab 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: -21.94 · 95% CI -32.54 to -11.35Placebo is the reference
  • A20 Placebo Q2W vs A20 Evolocumab 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: -20.01 · 95% CI -29.59 to -10.43Placebo is the reference
  • A20 Placebo QM vs A20 Evolocumab 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: -20.72 · 95% CI -34.18 to -7.26Placebo is the reference
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 changeA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Percent Change From Baseline in Triglycerides at Week 127.84 ± 7.654.34 ± 5.61-19.73 ± 7.74-15.63 ± 5.43-3.88 ± 4.857.30 ± 6.42-21.05 ± 4.82-9.63 ± 6.26
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: -27.57 · 95% CI -46.33 to -8.81Placebo is the reference
  • A5 Placebo QM vs A5 Evolocumab 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: -19.97 · 95% CI -31.68 to -8.25Placebo is the reference
  • A20 Placebo Q2W vs A20 Evolocumab 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: -17.17 · 95% CI -28.15 to -6.19Placebo is the reference
  • A20 Placebo QM vs A20 Evolocumab 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: -16.92 · 95% CI -31.29 to -2.56Placebo is the reference
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 changeA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Percent Change From Baseline in HDL-C at the Mean of Weeks 10 and 12-4.83 ± 2.25-1.57 ± 2.297.50 ± 2.3013.05 ± 2.22-4.03 ± 2.34-3.06 ± 2.1311.34 ± 2.336.09 ± 2.07
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: 12.33 · 95% CI 7.39 to 17.27Placebo is the reference
  • A5 Placebo QM vs A5 Evolocumab 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: 14.61 · 95% CI 9.93 to 19.30Placebo is the reference
  • A20 Placebo Q2W vs A20 Evolocumab 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: 15.36 · 95% CI 10.12 to 20.60Placebo is the reference
  • A20 Placebo QM vs A20 Evolocumab 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: 9.15 · 95% CI 4.67 to 13.62Placebo is the reference
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 changeA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Percent Change From Baseline in HDL-C at Week 12-4.59 ± 2.58-0.40 ± 2.478.88 ± 2.6214.80 ± 2.39-3.57 ± 2.59-2.36 ± 2.3813.28 ± 2.587.84 ± 2.32
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: 13.46 · 95% CI 7.40 to 19.53Placebo is the reference
  • A5 Placebo QM vs A5 Evolocumab 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: 15.20 · 95% CI 9.87 to 20.52Placebo is the reference
  • A20 Placebo Q2W vs A20 Evolocumab 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: 16.85 · 95% CI 10.74 to 22.95Placebo is the reference
  • A20 Placebo QM vs A20 Evolocumab 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: 10.20 · 95% CI 4.85 to 15.55Placebo is the reference
SecondaryPercent Change From Baseline in 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 VLDL-C at the Mean of Weeks 10 and 12
percent changeA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Percent Change From Baseline in VLDL-C at the Mean of Weeks 10 and 122.57 ± 5.523.10 ± 5.12-25.29 ± 5.65-19.55 ± 4.95-1.32 ± 4.329.96 ± 5.57-19.41 ± 4.31-17.20 ± 5.46
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: -27.85 · 95% CI -39.37 to -16.34Placebo is the reference
  • A5 Placebo QM vs A5 Evolocumab 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: -22.65 · 95% CI -32.91 to -12.39Placebo is the reference
  • A20 Placebo Q2W vs A20 Evolocumab 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: -18.09 · 95% CI -27.40 to -8.77Placebo is the reference
  • A20 Placebo QM vs A20 Evolocumab 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 -39.31 to -15.01Placebo is the reference
SecondaryPercent Change From Baseline in VLDL-C at Week 12
Time frame:
Baseline and Week 12
Reported as:
Least squares mean · percent change
Percent Change From Baseline in VLDL-C at Week 12
percent changeA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
Percent Change From Baseline in VLDL-C at Week 124.09 ± 6.222.92 ± 5.45-24.33 ± 6.34-17.89 ± 5.27-3.03 ± 4.709.17 ± 5.63-18.08 ± 4.68-15.18 ± 5.52
Statistical analysis
  • A5 Placebo Q2W vs A5 Evolocumab 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: -28.42 · 95% CI -42.48 to -14.36Placebo is the reference
  • A5 Placebo QM vs A5 Evolocumab 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: -20.81 · 95% CI -32.29 to -9.33Placebo is the reference
  • A20 Placebo Q2W vs A20 Evolocumab 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: -15.05 · 95% CI -25.72 to -4.39Placebo is the reference
  • A20 Placebo QM vs A20 Evolocumab 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: -24.35 · 95% CI -36.70 to -11.99Placebo is the reference

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
GroupDeathsSeriousOther
A5 Placebo Q2W—1/49 (2%)11/49 (22.4%)
A5 Placebo QM—2/50 (4%)11/50 (22%)
A5 Evolocumab Q2W—0/50 (0%)13/50 (26%)
A5 Evolocumab QM—1/50 (2%)9/50 (18%)
A20 Placebo Q2W—1/52 (1.9%)6/52 (11.5%)
A20 Placebo QM—1/51 (2%)14/51 (27.5%)
A20 Evolocumab Q2W—0/51 (0%)7/51 (13.7%)
A20 Evolocumab QM—0/51 (0%)12/51 (23.5%)
Most frequent serious events
Most frequent serious events
EventA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
EpilepsyNervous system disorders1/490/500/500/500/520/510/510/51
Pneumonia bacterialInfections and infestations0/490/500/501/500/520/510/510/51
ContusionInjury, poisoning and procedural complications0/491/500/500/500/520/510/510/51
Endometrial cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)0/491/500/500/500/520/510/510/51
Rotator cuff syndromeMusculoskeletal and connective tissue disorders0/490/500/500/500/521/510/510/51
Brain stem infarctionNervous system disorders0/490/500/500/501/520/510/510/51
Most frequent other events
Most frequent other events
EventA5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QM
NasopharyngitisInfections and infestations10/4910/5012/507/505/5211/517/518/51
GastroenteritisInfections and infestations1/490/501/502/501/520/510/513/51
Diabetes mellitusMetabolism and nutrition disorders0/491/501/500/500/523/511/512/51

Baseline characteristics

Full analysis set (all randomized participants who reveid at least 1 dose of blinded investigational product).

Age, Continuous
Age, Continuous(years)A5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QMTotal
Mean62.1 ± 9.960.6 ± 9.965.2 ± 7.860.1 ± 11.660.4 ± 10.460.4 ± 10.560.1 ± 9.961.8 ± 11.961.3 ± 10.3
Sex: Female, Male
Sex: Female, Male(Participants)A5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QMTotal
Female2215231824181624160
Male2735273228333527244
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)A5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QMTotal
American Indian or Alaska Native000000000
Asian4950505052515151404
Black or African American000000000
Native Hawaiian or Other Pacific Islander000000000
White000000000
Stratification Factor
Stratification Factor(participants)A5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QMTotal
Diagnosis of HeFH3223323321
Non-HeFH and Intensive Statin Use101011101111111185
Non-HeFH and Non-Intensive Statin Use3638373738383737298
LDL-C Concentration
LDL-C Concentration(mg/dL)A5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QMTotal
Mean115.7 ± 26.0114.0 ± 29.2121.9 ± 44.6118.8 ± 36.690.9 ± 25.590.7 ± 20.895.8 ± 23.698.0 ± 25.6105.5 ± 32.0
Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration
Non-High-Density Lipoprotein Cholesterol (non-HDL-C) Concentration(mg/dL)A5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QMTotal
Mean142.0 ± 30.4141.2 ± 31.8151.8 ± 48.8147.8 ± 39.6118.2 ± 28.6117.5 ± 25.1121.8 ± 29.8122.7 ± 29.5132.7 ± 35.9
Apolipoprotein B Concentration
Apolipoprotein B Concentration(mg/dL)A5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QMTotal
Mean99.0 ± 20.0100.6 ± 20.0105.1 ± 31.2102.2 ± 24.785.7 ± 18.482.7 ± 14.687.2 ± 19.187.7 ± 19.693.7 ± 22.8
Total Cholesterol Concentration
Total Cholesterol Concentration(mg/dL)A5 Placebo Q2WA5 Placebo QMA5 Evolocumab Q2WA5 Evolocumab QMA20 Placebo Q2WA20 Placebo QMA20 Evolocumab Q2WA20 Evolocumab QMTotal
Mean199.5 ± 30.7199.4 ± 33.2210.4 ± 47.9202.5 ± 38.4177.8 ± 33.0173.6 ± 29.2177.7 ± 26.2179.0 ± 29.4189.8 ± 36.3

6 further baseline measures are reported on the registry.

08

Study locations

54 sites
  • Research Site
    Akita, Akita 010-1423, Japan
  • Research Site
    Noda, Chiba 278-0004, Japan
  • Research Site
    Fukuoka, Fukuoka 810-0014, Japan
  • Research Site
    Fukuoka, Fukuoka 810-0066, Japan
  • Research Site
    Fukuoka, Fukuoka 819-8551, Japan
  • Research Site
    Kitakyusyu-shi, Fukuoka 807-0856, Japan
  • Research Site
    Koriyama-shi, Fukushima 963-0209, Japan
  • Research Site
    Koriyama-shi, Fukushima 963-8026, Japan
  • Research Site
    Koriyama-shi, Fukushima 963-8041, Japan
  • Research Site
    Koriyama-shi, Fukushima 963-8832, Japan
  • Research Site
    Koriyama-shi, Fukushima 963-8862, Japan
  • Research Site
    Maebashi, Gunma 371-0022, Japan
  • Research Site
    Takasaki-shi, Gunma 370-3524, Japan
  • Research Site
    Sapporo, Hokkaido 003-0026, Japan
  • Research Site
    Sapporo, Hokkaido 003-0825, Japan
  • Research Site
    Sapporo, Hokkaido 060-0063, Japan
  • Research Site
    Tsuchiura-shi, Ibaraki 300-0047, Japan
  • Research Site
    Hanamaki-shi, Iwate 025-0075, Japan
  • Research Site
    Morioka, Iwate 020-0066, Japan
  • Research Site
    Takamatsu, Kagawa-ken 760-0018, Japan
  • Research Site
    Takamatsu, Kagawa-ken 760-0076, Japan
  • Research Site
    Yokohama, Kanagawa 231-0023, Japan
  • Research Site
    Kyoto, Kyoto 615-8125, Japan
  • Research Site
    Sendai, Miyagi 983-0039, Japan
  • Research Site
    Sendai, Miyagi 983-0835, Japan
  • Research Site
    Sendai, Miyagi 989-3122, Japan
  • Research Site
    Tomigusuku-shi, Okinawa 901-0243, Japan
  • Research Site
    Urasoe-shi, Okinawa 901-2132, Japan
  • Research Site
    Ibaraki-shi, Osaka 567-0876, Japan
  • Research Site
    Osaka, Osaka 530-0001, Japan
  • Research Site
    Toyonaka-shi, Osaka 560-0082, Japan
  • Research Site
    Koshigaya-shi, Saitama 343-0826, Japan
  • Research Site
    Kumagaya-shi, Saitama 360-0816, Japan
  • Research Site
    Niiza-shi, Saitama 352-0014, Japan
  • Research Site
    Arakawa-ku, Tokyo 116-0002, Japan
  • Research Site
    Chiyoda-ku, Tokyo 101-0024, Japan
  • Research Site
    Chiyoda-ku, Tokyo 101-0041, Japan
  • Research Site
    Chofu-shi, Tokyo 182-0006, Japan
  • Research Site
    Chuo-ku, Tokyo 103-0027, Japan
  • Research Site
    Edogawa-ku, Tokyo 133-0061, Japan
  • Research Site
    Hachioji-shi, Tokyo 192-0046, Japan
  • Research Site
    Itabashi-ku, Tokyo 173-8610, Japan
  • Research Site
    Katsushika-ku, Tokyo 124-0024, Japan
  • Research Site
    Koto-ku, Tokyo 135-0011, Japan
  • Research Site
    Minato-ku, Tokyo 105-7390, Japan
  • Research Site
    Minato-ku, Tokyo 108-0075, Japan
  • Research Site
    Ōta-ku, Tokyo 144-0034, Japan
  • Research Site
    Setagaya-ku, Tokyo 155-0031, Japan
  • Research Site
    Shibuya-ku, Tokyo 150-0012, Japan
  • Research Site
    Shinagawa-ku, Tokyo 140-0011, Japan
  • Research Site
    Shinagawa-ku, Tokyo 141-0001, Japan
  • Research Site
    Shinagawa-ku, Tokyo 141-6003, Japan
  • Research Site
    Shinagawa-ku, Tokyo 142-0053, Japan
  • Research Site
    Toshima-ku, Tokyo 171-0021, Japan
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01953328
Lead sponsor
Amgen
Responsible party
Sponsor
First posted
Sep 30, 2013
Start date
Oct 2013
Primary completion
Jun 2014
Completion
Jun 2014
Results posted
Dec 23, 2015
Last update
Dec 23, 2015

Study contacts

MD
study director · Amgen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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