CompletedNCT03175367Updated Feb 10, 2023Results posted

Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia

A Phase 2 interventional study of Evinacumab and Matching placebo in Hypercholesterolemia, sponsored by Regeneron Pharmaceuticals. Completed at 95 sites in 20 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-10.

Sponsored by Regeneron Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 272
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study summary

The primary objective of the study is to evaluate the reduction of LDL-C by evinacumab in comparison to placebo after 16 weeks in patients with primary hypercholesterolemia (HeFH, or non-HeFH with a history of clinical ASCVD) with persistent hypercholesterolemia despite receiving maximally-tolerated LMT. Persistent hypercholesterolemia is defined as LDL-C ≥70 mg/dL (1.81 mmol/L) for those patients with clinical ASCVD and LDL-C ≥100 mg/dL (2.59 mmol/L) for those patients without clinical ASCVD.

Conditions studied

Hypercholesterolemia

Browse trials for

Hypercholesterolemia 1,238

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 272 is above the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.

Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) 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

Eligibility criteria

The inclusion/ exclusion criteria below, include, but are not limited to, the following:

Key Inclusion Criteria:

Men and women, ages 18 through 80 at the screening visit
Diagnosis of primary hypercholesterolemia, either HeFH or non-HeFH with clinical ASCVD
A history of clinical ASCVD, for those patients who are non-HeFH.
Receiving a stable maximally tolerated statin (± ezetimibe) for at least 4 weeks at screening
For those patients with HeFH who are not receiving a statin at screening, documentation of inability to tolerate at least 2 statins.
Receiving alirocumab 150 mg SC Q2W, OR evolocumab 140 mg SC Q2W or 420 mg SC Q4W for at least 8 weeks prior to the screening visit
For those patients with a history of clinical ASCVD, serum LDL-C ≥ 70 mg/dL at screening (1 repeat lab is allowed)
For those patients without a history of clinical ASCVD, serum LDL-C ≥ 100 mg/dL at screening (1 repeat lab is allowed)
Provide signed informed consent

Key Exclusion Criteria:

Known history of homozygous FH (clinically, or by previous genotyping)
Presence of any clinically significant uncontrolled endocrine disease known to influence serum lipids or lipoproteins
Newly diagnosed diabetes (within 3 months prior to screening)
Use of thyroid medications (except for replacement therapy which has been stable for at least 12 weeks before screening)
Laboratory findings during screening period (not including randomization labs):
1. Triglycerides > 400 mg/dL (> 4.52 mmol/L) for patients without a known history of diabetes mellitus; OR Triglycerides > 300 mg/dL (> 3.39 mmol/L) for patients with a known history of diabetes mellitus
2. Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody (associated with a positive HCV ribonucleic acid [RNA] polymerase chain reaction)
3. Positive serum beta-human chorionic gonadotropin or urine pregnancy test in women of childbearing potential
4. Estimated glomerular filtration rate \< 30 mL/min/1.73 m\^2
5. TSH > 1.5 x ULN
6. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 x ULN
Systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg at screening visit or time of randomization
History of heart failure (New York Heart Association [NYHA] Class III-IV) within 12 months before screening
History of MI, unstable angina leading to hospitalization, CABG surgery, PCI, uncontrolled cardiac arrhythmia, carotid surgery or stenting, stroke, TIA, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease within 3 months prior screening
History of cancer within the past 5 years (except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer)
Having received LDL apheresis within 2 months before screening
Pregnant or breast-feeding women
Women of childbearing potential who are unwilling to practice a highly effective birth control method
Men who are sexually active with women of childbearing potential (WOCBP) and are unwilling to consistently use condoms during the study drug treatment period regardless of vasectomy status.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 272 participants (actual)

Study arms

Experimental
Group A: dosing regimen 1
SC Evinacumab QW for 16 weeks
Drug: Evinacumab · Other: Background Lipid Modifying Therapy (LMT)
Experimental
Group A: dosing regimen 2
SC Evinacumab Q2W for 16 weeks (alternating with matching placebo on opposite weeks)
Drug: Evinacumab · Other: Background Lipid Modifying Therapy (LMT)
Experimental
Group A: dosing regimen 3
SC Evinacumab QW for 16 weeks
Drug: Evinacumab · Other: Background Lipid Modifying Therapy (LMT)
Experimental
Group A: matching placebo
Placebo SC QW for 16 weeks
Drug: Matching placebo · Other: Background Lipid Modifying Therapy (LMT)
Experimental
Group B: dosing regimen 1
Intravenous (IV) Evinacumab Q4W for 24 weeks
Drug: Evinacumab · Other: Background Lipid Modifying Therapy (LMT)
Experimental
Group B: dosing regimen 2
IV Evinacumab Q4W for 24 weeks
Drug: Evinacumab · Other: Background Lipid Modifying Therapy (LMT)
Experimental
Group B: matching placebo
Placebo IV Q4W for 24 weeks
Drug: Matching placebo · Other: Background Lipid Modifying Therapy (LMT)

Interventions

DrugEvinacumab
SC or IV administration
Also known as: REGN1500
DrugMatching placebo
SC or IV administration
OtherBackground Lipid Modifying Therapy (LMT)
All participants should be on a stable, maximally tolerated statin throughout the duration of the study. The dose of statin and of PCSK9 inhibitor, such as alirocumab or evolocumab, as well as other LMT (if applicable), should remain stable throughout the study duration, from screening through the end of study (EOS) visit.

What researchers measure

Primary outcomes

Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand)
Time frame: Baseline and Week 16

Secondary outcomes

Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 (ITT Estimand)
Time frame: Baseline and Week 16
Percent Change From Baseline in Apo B at Week 24 (ITT Estimand)
Time frame: Baseline and Week 24
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16 (ITT Estimand)
Time frame: Baseline and Week 16
Percent Change From Baseline in Non-HDL-C at Week 24 (ITT Estimand)
Time frame: Baseline and Week 24
Percentage of Participants With >= 30% Reduction in Calculated LDL-C at Week 16 (ITT Estimand)
Time frame: Week 16
Percentage of Participants With >= 50% Reduction in Calculated LDL-C at Week 16 (ITT Estimand)
Time frame: Week 16
Percentage of Participants With Calculated LDL-C < 50 mg/dL (1.30 mmol/L) at Week 16 (ITT Estimand)
Percentage of Participants with Calculated LDL-C \< 50 milligrams/deciliter (mg/dL) \[1.30 Millimoles per liter (mmol/L)\] at Week 16 (ITT Estimand)
Time frame: Week 16
Percent Change From Baseline in Calculated LDL-C at Week 24 (ITT Estimand)
Time frame: Baseline and Week 24
Percent Change From Baseline in Total Cholesterol (TC) at Week 16 (ITT Estimand)
Time frame: Baseline and Week 16
Percent Change From Baseline in Total Cholesterol at Week 24 (ITT Estimand)
Time frame: Baseline and Week 24
Percent Change From Baseline in Fasting Triglycerides at Week 16 (ITT Estimand)
Time frame: Baseline and Week 16
Percent Change From Baseline in Fasting Triglycerides at Week 24 (ITT Estimand)
Time frame: Baseline and Week 24
Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 16 (ITT Estimand)
Time frame: Baseline and Week 16
Percent Change From Baseline in Lipoprotein (a) [Lp(a)] at Week 24 (ITT Estimand)
Time frame: Baseline and Week 24

Results

Posted Feb 10, 2023

Participant flow

Double-blind Treatment Period (DBTP)

Participant flow — Double-blind Treatment Period (DBTP)
Milestone	Group A: Placebo SC QW (DBTP)	Group A: Evinacumab 300 mg SC Q2W (DBTP)	Group A: Evinacumab 300 mg SC QW (DBTP)	Group A: Evinacumab 450 mg SC QW (DBTP)	Group B: Placebo IV Q4W (DBTP to OLTP)	Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)	Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Started	39	39	42	40	33	35	38
Completed	30	31	30	30	31	32	34
Not completed	9	8	12	10	2	3	4
Withdrew: Protocol violation	0	0	1	2	0	0	2
Withdrew: Adverse event	2	2	0	0	1	2	2
Withdrew: Withdrawal by subject	1	1	2	2	0	1	0
Withdrew: Physician decision	6	5	8	6	0	0	0
Withdrew: Lost to follow-up	0	0	1	0	1	0	0

Open-Label Treatment Period (OLTP)

Participant flow — Open-Label Treatment Period (OLTP)
Milestone	Group B: Placebo IV Q4W (DBTP to OLTP)	Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)	Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Started	31	32	33
Completed	31	30	31
Not completed	0	2	2
Withdrew: Noncompliance with protocol	0	0	1
Withdrew: Withdrawal by subject	0	2	1

Outcome measures

PrimaryPercent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand)

Time frame:: Baseline and Week 16
Reported as:: Least squares mean · Percent Change

Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand)
Percent Change	Group A: Placebo SC QW (DBTP)	Group A: Evinacumab 300 mg SC Q2W (DBTP)	Group A: Evinacumab 300 mg SC QW (DBTP)	Group A: Evinacumab 450 mg SC QW (DBTP)	Group B: Placebo IV Q4W (DBTP to OLTP)	Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)	Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand)	8.8 ± 6.4	-29.7 ± 6.4	-44.0 ± 6.3	-47.2 ± 6.2	0.6 ± 6.6	-23.5 ± 6.6	-49.9 ± 6.1

Statistical analysis

Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 300 mg SC Q2W (DBTP) · Mixed Models Analysis · p = < .0001 · Least squares mean difference: -38.5 · 95% CI -56.5 to -20.6
Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 300 mg SC QW (DBTP) · Mixed Models Analysis · p = < .0001 · Least squares mean difference: -52.9 · 95% CI -70.7 to -35.1
Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 450 mg SC QW (DBTP) · Mixed Models Analysis · p = < .0001 · Least squares mean difference: -56.0 · 95% CI -73.7 to -38.3
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP) · Mixed Models Analysis · p = = 0.0109 (P-Value is not adjusted for multiplicity) · Least squares mean difference: -24.2 · 95% CI -42.6 to -5.7
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP) · Mixed Models Analysis · p = < .0001 · Least squares mean difference: -50.5 · 95% CI -68.4 to -32.6

SecondaryPercent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 (ITT Estimand)

Time frame:: Baseline and Week 16
Reported as:: Least squares mean · Percent Change

Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 (ITT Estimand)
Percent Change	Group A: Placebo SC QW (DBTP)	Group A: Evinacumab 300 mg SC Q2W (DBTP)	Group A: Evinacumab 300 mg SC QW (DBTP)	Group A: Evinacumab 450 mg SC QW (DBTP)	Group B: Placebo IV Q4W (DBTP to OLTP)	Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)	Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Percent Change From Baseline in Apolipoprotein B (Apo B) at Week 16 (ITT Estimand)	6.7 ± 5.1	-19.9 ± 5.1	-35.2 ± 5.1	-38.8 ± 4.9	-3.8 ± 4.7	-20.4 ± 4.6	-43.2 ± 4.3

Statistical analysis

Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 300 mg SC Q2W (DBTP) · Mixed Models Analysis · p = = 0.0003 · Least squares mean difference: -26.6 · 95% CI -40.9 to -12.4
Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 300 mg SC QW (DBTP) · Mixed Models Analysis · p = < 0.0001 · Least squares mean difference: -42.0 · 95% CI -56.1 to -27.9
Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 450 mg SC QW (DBTP) · Mixed Models Analysis · p = < 0.0001 · Least squares mean difference: -45.5 · 95% CI -59.5 to -31.5
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP) · Mixed Models Analysis · p = = 0.0132 · Least squares mean difference: -16.6 · 95% CI -29.7 to -3.5
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP) · Mixed Models Analysis · p = < 0.0001 · Least squares mean difference: -39.4 · 95% CI -52.0 to -26.8

SecondaryPercent Change From Baseline in Apo B at Week 24 (ITT Estimand)

Time frame:: Baseline and Week 24
Reported as:: Least squares mean · Percent Change

Percent Change From Baseline in Apo B at Week 24 (ITT Estimand)
Percent Change	Group B: Placebo IV Q4W (DBTP to OLTP)	Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)	Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Percent Change From Baseline in Apo B at Week 24 (ITT Estimand)	5.9 ± 6.0	-15.9 ± 5.9	-34.5 ± 5.6

Statistical analysis

Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP) · Mixed Models Analysis · p = = 0.0111 · Least squares mean difference: -21.8 · 95% CI -38.4 to -5.1
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP) · Mixed Models Analysis · p = < 0.0001 · Least squares mean difference: -40.4 · 95% CI -56.7 to -24.0

SecondaryPercent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16 (ITT Estimand)

Time frame:: Baseline and Week 16
Reported as:: Least squares mean · Percent Change

Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16 (ITT Estimand)
Percent Change	Group A: Placebo SC QW (DBTP)	Group A: Evinacumab 300 mg SC Q2W (DBTP)	Group A: Evinacumab 300 mg SC QW (DBTP)	Group A: Evinacumab 450 mg SC QW (DBTP)	Group B: Placebo IV Q4W (DBTP to OLTP)	Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)	Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Percent Change From Baseline in Non High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 16 (ITT Estimand)	8.0 ± 5.4	-31.3 ± 5.4	-45.8 ± 5.3	-50.6 ± 5.2	-1.1 ± 5.8	-24.8 ± 5.7	-52.0 ± 5.3

Statistical analysis

Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 300 mg SC Q2W (DBTP) · Mixed Models Analysis · p = < 0.0001 · Least squares mean difference: -39.3 · 95% CI -54.4 to -24.3
Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 300 mg SC QW (DBTP) · Mixed Models Analysis · p = < 0.0001 · Least squares mean difference: -53.8 · 95% CI -68.8 to -38.9
Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 450 mg SC QW (DBTP) · Mixed Models Analysis · p = < 0.0001 · Least squares mean difference: -58.5 · 95% CI -73.4 to -43.7
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP) · Mixed Models Analysis · p = = 0.0042 · Least squares mean difference: -23.7 · 95% CI -39.7 to -7.7
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP) · Mixed Models Analysis · p = < 0.0001 · Least squares mean difference: -50.9 · 95% CI -66.4 to -35.4

SecondaryPercent Change From Baseline in Non-HDL-C at Week 24 (ITT Estimand)

Time frame:: Baseline and Week 24
Reported as:: Least squares mean · Percent Change

Percent Change From Baseline in Non-HDL-C at Week 24 (ITT Estimand)
Percent Change	Group B: Placebo IV Q4W (DBTP to OLTP)	Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)	Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Percent Change From Baseline in Non-HDL-C at Week 24 (ITT Estimand)	10.4 ± 7.0	-20.2 ± 6.7	-44.3 ± 6.4

Statistical analysis

Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP) · Mixed Models Analysis · p = = 0.0021 · Least squares mean difference: -30.6 · 95% CI -49.8 to -11.4
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP) · Mixed Models Analysis · p = < 0.0001 · Least squares mean difference: -54.6 · 95% CI -73.4 to -35.8

SecondaryPercentage of Participants With >= 30% Reduction in Calculated LDL-C at Week 16 (ITT Estimand)

Time frame:: Week 16
Reported as:: Number · Percentage of Participants

Percentage of Participants With >= 30% Reduction in Calculated LDL-C at Week 16 (ITT Estimand)
Percentage of Participants	Group A: Placebo SC QW (DBTP)	Group A: Evinacumab 300 mg SC Q2W (DBTP)	Group A: Evinacumab 300 mg SC QW (DBTP)	Group A: Evinacumab 450 mg SC QW (DBTP)	Group B: Placebo IV Q4W (DBTP to OLTP)	Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)	Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Percentage of Participants With >= 30% Reduction in Calculated LDL-C at Week 16 (ITT Estimand)	11.3	68.1	73.9	71.4	15.5	57.9	86.8

Statistical analysis

Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 300 mg SC Q2W (DBTP) · Regression, Logistic · p = < 0.0001 · Odds ratio, log: 19.4 · 95% CI 5.1 to 72.8
Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 300 mg SC QW (DBTP) · Regression, Logistic · p = < 0.0001 · Odds ratio, log: 23.9 · 95% CI 6.4 to 89.2
Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 450 mg SC QW (DBTP) · Regression, Logistic · p = < 0.0001 · Odds ratio, log: 22.1 · 95% CI 6.0 to 80.5
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP) · Regression, Logistic · p = = 0.0007 · Odds ratio, log: 8.5 · 95% CI 2.5 to 29.2
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP) · Regression, Logistic · p = < 0.0001 · Odds ratio, log: 42.3 · 95% CI 10.4 to 172.3

SecondaryPercentage of Participants With >= 50% Reduction in Calculated LDL-C at Week 16 (ITT Estimand)

Time frame:: Week 16
Reported as:: Number · Percentage of Participants

Percentage of Participants With >= 50% Reduction in Calculated LDL-C at Week 16 (ITT Estimand)
Percentage of Participants	Group A: Placebo SC QW (DBTP)	Group A: Evinacumab 300 mg SC Q2W (DBTP)	Group A: Evinacumab 300 mg SC QW (DBTP)	Group A: Evinacumab 450 mg SC QW (DBTP)	Group B: Placebo IV Q4W (DBTP to OLTP)	Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)	Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Percentage of Participants With >= 50% Reduction in Calculated LDL-C at Week 16 (ITT Estimand)	5.2	28.6	53.7	60.6	12.3	24.6	63.2

Statistical analysis

Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 300 mg SC Q2W (DBTP) · Regression, Logistic · p = = 0.0100 · Odds ratio (or): 9.6 · 95% CI 1.7 to 53.5
Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 300 mg SC QW (DBTP) · Regression, Logistic · p = = 0.0001 · Odds ratio (or): 24.8 · 95% CI 4.7 to 129.9
Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 450 mg SC QW (DBTP) · Regression, Logistic · p = < 0.0001 · Odds ratio (or): 36.1 · 95% CI 6.7 to 194.7
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP) · Regression, Logistic · p = = 0.3185 · Odds ratio (or): 2.0 · 95% CI 0.5 to 8.2
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP) · Regression, Logistic · p = < 0.0001 · Odds ratio (or): 14.5 · 95% CI 3.9 to 54.2

SecondaryPercentage of Participants With Calculated LDL-C < 50 mg/dL (1.30 mmol/L) at Week 16 (ITT Estimand)

Percentage of Participants with Calculated LDL-C \< 50 milligrams/deciliter (mg/dL) \[1.30 Millimoles per liter (mmol/L)\] at Week 16 (ITT Estimand)

Time frame:: Week 16
Reported as:: Number · Percentage of Participants

Percentage of Participants With Calculated LDL-C < 50 mg/dL (1.30 mmol/L) at Week 16 (ITT Estimand)
Percentage of Participants	Group A: Placebo SC QW (DBTP)	Group A: Evinacumab 300 mg SC Q2W (DBTP)	Group A: Evinacumab 300 mg SC QW (DBTP)	Group A: Evinacumab 450 mg SC QW (DBTP)	Group B: Placebo IV Q4W (DBTP to OLTP)	Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)	Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Percentage of Participants With Calculated LDL-C < 50 mg/dL (1.30 mmol/L) at Week 16 (ITT Estimand)	5.1	22.8	29.7	40.8	9.3	13.2	39.5

Statistical analysis

Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 300 mg SC Q2W (DBTP) · Regression, Logistic · p = = 0.0718 · Odds ratio (or): 4.8 · 95% CI 0.9 to 26.5
Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 300 mg SC QW (DBTP) · Regression, Logistic · p = = 0.0048 · Odds ratio (or): 11.4 · 95% CI 2.1 to 62.1
Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 450 mg SC QW (DBTP) · Regression, Logistic · p = = 0.0015 · Odds ratio (or): 14.7 · 95% CI 2.8 to 76.8
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP) · Regression, Logistic · p = = 0.5270 · Odds ratio (or): 1.7 · 95% CI 0.3 to 8.4
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP) · Regression, Logistic · p = = 0.0047 · Odds ratio (or): 7.7 · 95% CI 1.9 to 31.7

SecondaryPercent Change From Baseline in Calculated LDL-C at Week 24 (ITT Estimand)

Time frame:: Baseline and Week 24
Reported as:: Least squares mean · Percent Change

Percent Change From Baseline in Calculated LDL-C at Week 24 (ITT Estimand)
Percent Change	Group B: Placebo IV Q4W (DBTP to OLTP)	Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)	Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Percent Change From Baseline in Calculated LDL-C at Week 24 (ITT Estimand)	14.8 ± 8.3	-17.7 ± 8.0	-39.7 ± 7.7

Statistical analysis

Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP) · Mixed Models Analysis · p = = 0.0059 · Least squares mean difference: -32.5 · 95% CI -55.5 to -9.6
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP) · Mixed Models Analysis · p = < 0.0001 · Least squares mean difference: -54.5 · 95% CI -77.0 to -32.0

SecondaryPercent Change From Baseline in Total Cholesterol (TC) at Week 16 (ITT Estimand)

Time frame:: Baseline and Week 16
Reported as:: Least squares mean · Percent Change

Percent Change From Baseline in Total Cholesterol (TC) at Week 16 (ITT Estimand)
Percent Change	Group A: Placebo SC QW (DBTP)	Group A: Evinacumab 300 mg SC Q2W (DBTP)	Group A: Evinacumab 300 mg SC QW (DBTP)	Group A: Evinacumab 450 mg SC QW (DBTP)	Group B: Placebo IV Q4W (DBTP to OLTP)	Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)	Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Percent Change From Baseline in Total Cholesterol (TC) at Week 16 (ITT Estimand)	6.1 ± 4.0	-31.0 ± 4.0	-40.3 ± 4.0	-45.4 ± 3.9	-0.4 ± 4.5	-22.6 ± 4.4	-46.8 ± 4.1

Statistical analysis

Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 300 mg SC Q2W (DBTP) · Mixed Models Analysis · p = < .0001 · Least squares mean difference: -37.1 · 95% CI -48.4 to -25.8
Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 300 mg SC QW (DBTP) · Mixed Models Analysis · p = < .0001 · Least squares mean difference: -46.4 · 95% CI -57.5 to -35.2
Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 450 mg SC QW (DBTP) · Mixed Models Analysis · p = < .0001 · Least squares mean difference: -51.5 · 95% CI -62.5 to -40.4
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP) · Mixed Models Analysis · p = = 0.0006 · Least squares mean difference: -22.2 · 95% CI -34.6 to -9.8
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP) · Mixed Models Analysis · p = < .0001 · Least squares mean difference: -46.4 · 95% CI -58.4 to -34.4

SecondaryPercent Change From Baseline in Total Cholesterol at Week 24 (ITT Estimand)

Time frame:: Baseline and Week 24
Reported as:: Least squares mean · Percent Change

Percent Change From Baseline in Total Cholesterol at Week 24 (ITT Estimand)
Percent Change	Group B: Placebo IV Q4W (DBTP to OLTP)	Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)	Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Percent Change From Baseline in Total Cholesterol at Week 24 (ITT Estimand)	8.5 ± 5.1	-19.9 ± 4.9	-40.8 ± 4.7

Statistical analysis

Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP) · Mixed Models Analysis · p = = 0.0001 · Least squares mean difference: -28.4 · 95% CI -42.6 to -14.3
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP) · Mixed Models Analysis · p = < .0001 · Least squares mean difference: -49.3 · 95% CI -63.2 to -35.4

SecondaryPercent Change From Baseline in Fasting Triglycerides at Week 16 (ITT Estimand)

Time frame:: Baseline and Week 16
Reported as:: Least squares mean · Percent Change

Percent Change From Baseline in Fasting Triglycerides at Week 16 (ITT Estimand)
Percent Change	Group A: Placebo SC QW (DBTP)	Group A: Evinacumab 300 mg SC Q2W (DBTP)	Group A: Evinacumab 300 mg SC QW (DBTP)	Group A: Evinacumab 450 mg SC QW (DBTP)	Group B: Placebo IV Q4W (DBTP to OLTP)	Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)	Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Percent Change From Baseline in Fasting Triglycerides at Week 16 (ITT Estimand)	8.1 ± 4.5	-38.0 ± 4.2	-47.7 ± 4.0	-53.4 ± 3.9	-6.9 ± 4.7	-32.1 ± 4.5	-52.8 ± 4.1

Statistical analysis

Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 300 mg SC Q2W (DBTP) · Regression, Linear · p = < .0001 · Adjusted mean difference: -46.1 · 95% CI -57.8 to -34.3
Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 300 mg SC QW (DBTP) · Regression, Linear · p = < .0001 · Adjusted mean difference: -55.8 · 95% CI -67.3 to -44.3
Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 450 mg SC QW (DBTP) · Regression, Linear · p = < .0001 · Adjusted mean difference: -61.5 · 95% CI -72.9 to -50.0
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP) · Regression, Linear · p = = 0.0001 · Adjusted mean difference: -25.2 · 95% CI -38.0 to -12.4
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP) · Regression, Linear · p = < .0001 · Adjusted mean difference: -45.9 · 95% CI -58.4 to -33.5

SecondaryPercent Change From Baseline in Fasting Triglycerides at Week 24 (ITT Estimand)

Time frame:: Baseline and Week 24
Reported as:: Least squares mean · Percent Change

Percent Change From Baseline in Fasting Triglycerides at Week 24 (ITT Estimand)
Percent Change	Group B: Placebo IV Q4W (DBTP to OLTP)	Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)	Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Percent Change From Baseline in Fasting Triglycerides at Week 24 (ITT Estimand)	-6.1 ± 5.4	-23.2 ± 5.1	-51.3 ± 4.8

Statistical analysis

Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP) · Regression, Linear · p = = 0.0228 · Adjusted mean difference: -17.1 · 95% CI -31.8 to -2.4
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP) · Regression, Linear · p = < .0001 · Adjusted mean difference: -45.3 · 95% CI -59.6 to -31.0

SecondaryPercent Change From Baseline in Lipoprotein a [Lp(a)] at Week 16 (ITT Estimand)

Time frame:: Baseline and Week 16
Reported as:: Least squares mean · Percent Change

Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 16 (ITT Estimand)
Percent Change	Group A: Placebo SC QW (DBTP)	Group A: Evinacumab 300 mg SC Q2W (DBTP)	Group A: Evinacumab 300 mg SC QW (DBTP)	Group A: Evinacumab 450 mg SC QW (DBTP)	Group B: Placebo IV Q4W (DBTP to OLTP)	Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)	Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Percent Change From Baseline in Lipoprotein a [Lp(a)] at Week 16 (ITT Estimand)	0.3 ± 3.9	-10.3 ± 4.1	-11.6 ± 4.0	-8.9 ± 4.0	0.8 ± 3.7	-15.7 ± 3.7	-15.7 ± 3.3

Statistical analysis

Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 300 mg SC Q2W (DBTP) · Regression, Linear · p = = 0.0635 · Adjusted mean difference: -10.6 · 95% CI -21.8 to 0.6
Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 300 mg SC QW (DBTP) · Regression, Linear · p = = 0.0314 · Adjusted mean difference: -11.9 · 95% CI -22.8 to -1.1
Group A: Placebo SC QW (DBTP) vs Group A: Evinacumab 450 mg SC QW (DBTP) · Regression, Linear · p = = 0.0923 · Adjusted mean difference: -9.2 · 95% CI -19.9 to 1.5
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP) · Regression, Linear · p = = 0.0017 · Adjusted mean difference: -16.5 · 95% CI -26.8 to -6.2
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP) · Regression, Linear · p = = 0.0009 · Adjusted mean difference: -16.5 · 95% CI -26.2 to -6.8

SecondaryPercent Change From Baseline in Lipoprotein (a) [Lp(a)] at Week 24 (ITT Estimand)

Time frame:: Baseline and Week 24
Reported as:: Least squares mean · Percent Change

Percent Change From Baseline in Lipoprotein (a) [Lp(a)] at Week 24 (ITT Estimand)
Percent Change	Group B: Placebo IV Q4W (DBTP to OLTP)	Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)	Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)
Percent Change From Baseline in Lipoprotein (a) [Lp(a)] at Week 24 (ITT Estimand)	-1.4 ± 4.1	-17.5 ± 4.0	-16.0 ± 3.7

Statistical analysis

Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP) · Regression, Linear · p = = 0.0054 · Adjusted mean difference: -16.1 · 95% CI -27.4 to -4.7
Group B: Placebo IV Q4W (DBTP to OLTP) vs Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP) · Regression, Linear · p = = 0.0085 · Adjusted mean difference: -14.6 · 95% CI -25.4 to -3.7

Adverse events

Collected over Group A from day of first treatment up to 39 weeks, Group B from day of first treatment up to 92 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Group A: Placebo SC QW (DBTP)	0/39 (0%)	3/39 (7.7%)	20/39 (51.3%)
Group A: Evinacumab 300 mg SC Q2W (DBTP)	1/39 (2.6%)	2/39 (5.1%)	27/39 (69.2%)
Group A: Evinacumab 300 mg SC QW (DBTP)	1/42 (2.4%)	4/42 (9.5%)	26/42 (61.9%)
Group A: Evinacumab 450 mg SC QW (DBTP)	0/40 (0%)	4/40 (10%)	22/40 (55%)
Group B: Placebo IV Q4W (DBTP)	0/33 (0%)	1/33 (3%)	18/33 (54.5%)
Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)	0/36 (0%)	2/36 (5.6%)	23/36 (63.9%)
Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)	0/37 (0%)	6/37 (16.2%)	24/37 (64.9%)
Group B: Placebo IV Q4W (OLTP)	0/31 (0%)	4/31 (12.9%)	19/31 (61.3%)
Group B: Evinacumab 5 mg/kg IV Q4W (OLTP)	0/32 (0%)	3/32 (9.4%)	22/32 (68.8%)
Group B: Evinacumab 15 mg/kg IV Q4W (OLTP)	0/33 (0%)	2/33 (6.1%)	24/33 (72.7%)

Most frequent serious events

Showing 10 of 36

Most frequent serious events
Event	Group A: Placebo SC QW (DBTP)	Group A: Evinacumab 300 mg SC Q2W (DBTP)	Group A: Evinacumab 300 mg SC QW (DBTP)	Group A: Evinacumab 450 mg SC QW (DBTP)	Group B: Placebo IV Q4W (DBTP)	Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)	Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)	Group B: Placebo IV Q4W (OLTP)	Group B: Evinacumab 5 mg/kg IV Q4W (OLTP)	Group B: Evinacumab 15 mg/kg IV Q4W (OLTP)
Atrial fibrillationCardiac disorders	0/39	0/39	0/42	0/40	0/33	0/36	1/37	1/31	0/32	1/33
Gastrointestinal motility disorderGastrointestinal disorders	0/39	0/39	0/42	0/40	0/33	0/36	0/37	1/31	0/32	0/33
Corona virus infectionInfections and infestations	0/39	0/39	0/42	0/40	0/33	0/36	0/37	1/31	0/32	0/33
Transitional cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/39	0/39	0/42	0/40	0/33	0/36	0/37	1/31	0/32	0/33
Carotid artery stenosisNervous system disorders	0/39	0/39	0/42	0/40	0/33	0/36	0/37	1/31	0/32	0/33
Pulmonary embolismRespiratory, thoracic and mediastinal disorders	0/39	0/39	0/42	0/40	0/33	0/36	0/37	0/31	1/32	0/33
Gallbladder polypHepatobiliary disorders	0/39	0/39	0/42	0/40	0/33	0/36	0/37	0/31	1/32	0/33
Joint effusionMusculoskeletal and connective tissue disorders	0/39	0/39	0/42	0/40	0/33	0/36	0/37	0/31	1/32	0/33
Dyspnoea exertionalRespiratory, thoracic and mediastinal disorders	0/39	0/39	0/42	0/40	1/33	0/36	0/37	0/31	0/32	0/33
DyspnoeaRespiratory, thoracic and mediastinal disorders	0/39	0/39	0/42	0/40	0/33	0/36	0/37	0/31	0/32	1/33

Most frequent other events

Showing 10 of 58

Most frequent other events
Event	Group A: Placebo SC QW (DBTP)	Group A: Evinacumab 300 mg SC Q2W (DBTP)	Group A: Evinacumab 300 mg SC QW (DBTP)	Group A: Evinacumab 450 mg SC QW (DBTP)	Group B: Placebo IV Q4W (DBTP)	Group B: Evinacumab 5 mg/kg IV Q4W (DBTP)	Group B: Evinacumab 15 mg/kg IV Q4W (DBTP)	Group B: Placebo IV Q4W (OLTP)	Group B: Evinacumab 5 mg/kg IV Q4W (OLTP)	Group B: Evinacumab 15 mg/kg IV Q4W (OLTP)
Urinary tract infectionInfections and infestations	4/39	5/39	5/42	4/40	0/33	2/36	0/37	2/31	6/32	3/33
HeadacheNervous system disorders	4/39	2/39	3/42	4/40	6/33	2/36	5/37	4/31	2/32	4/33
NasopharyngitisInfections and infestations	6/39	4/39	4/42	4/40	2/33	3/36	6/37	5/31	4/32	3/33
MyalgiaMusculoskeletal and connective tissue disorders	0/39	4/39	1/42	2/40	4/33	5/36	2/37	2/31	1/32	0/33
Back painMusculoskeletal and connective tissue disorders	5/39	3/39	4/42	2/40	2/33	3/36	2/37	2/31	3/32	0/33
DizzinessNervous system disorders	5/39	1/39	2/42	1/40	0/33	2/36	3/37	0/31	1/32	0/33
Influenza like illnessGeneral disorders	0/39	2/39	0/42	3/40	3/33	3/36	1/37	1/31	3/32	4/33
FatigueGeneral disorders	3/39	0/39	2/42	4/40	2/33	4/36	1/37	3/31	2/32	0/33
Abdominal painGastrointestinal disorders	4/39	1/39	0/42	0/40	0/33	2/36	2/37	1/31	1/32	0/33
ConstipationGastrointestinal disorders	1/39	4/39	0/42	0/40	0/33	2/36	1/37	0/31	0/32	0/33

Baseline characteristics

Age, Customized
Age, Customized(Participants)	Group A: Placebo SC QW (DBTP)	Group A: Evinacumab 300 mg SC Q2W (DBTP)	Group A: Evinacumab 300 mg SC QW (DBTP)	Group A: Evinacumab 450 mg SC QW (DBTP)	Group B: Placebo IV Q4W (DBTP to OLTP)	Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)	Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)	Total
Adults (18-64 years)	34	29	34	30	26	28	33	214
From 65-84 years	5	10	8	10	7	7	5	52
85 years and over	0	0	0	0	0	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Group A: Placebo SC QW (DBTP)	Group A: Evinacumab 300 mg SC Q2W (DBTP)	Group A: Evinacumab 300 mg SC QW (DBTP)	Group A: Evinacumab 450 mg SC QW (DBTP)	Group B: Placebo IV Q4W (DBTP to OLTP)	Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)	Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)	Total
Female	27	21	23	29	18	22	19	159
Male	12	18	19	11	15	13	19	107

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Group A: Placebo SC QW (DBTP)	Group A: Evinacumab 300 mg SC Q2W (DBTP)	Group A: Evinacumab 300 mg SC QW (DBTP)	Group A: Evinacumab 450 mg SC QW (DBTP)	Group B: Placebo IV Q4W (DBTP to OLTP)	Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)	Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)	Total
Hispanic or Latino	2	5	2	2	3	7	2	23
Not Hispanic or Latino	36	31	38	38	30	28	36	237
Unknown or Not Reported	1	3	2	0	0	0	0	6

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Group A: Placebo SC QW (DBTP)	Group A: Evinacumab 300 mg SC Q2W (DBTP)	Group A: Evinacumab 300 mg SC QW (DBTP)	Group A: Evinacumab 450 mg SC QW (DBTP)	Group B: Placebo IV Q4W (DBTP to OLTP)	Group B: Evinacumab 5 mg/kg IV Q4W (DBTP to OLTP)	Group B: Evinacumab 15 mg/kg IV Q4W (DBTP to OLTP)	Total
American Indian or Alaska Native	0	0	0	0	0	0	0	0
Asian	1	2	0	0	1	1	0	5
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0
Black or African American	3	0	0	1	2	0	0	6
White	34	34	39	38	27	32	35	239
More than one race	0	0	0	0	0	0	0	0
Unknown or Not Reported	1	3	3	1	3	2	3	16

Study locations

95 sites

Cedars-Sinai Medical Center
Los Angeles, California 90048, United States
Office of Dr. John D Homan MD
Newport Beach, California 92663-3668, United States
Preventive Cardiology Inc
Boca Raton, Florida 33434, United States
Care Research Center Inc
Doral, Florida 33166, United States
Florida Lipid Institute
Winter Park, Florida 32792, United States
St. Vincent Medical Group, Inc
Indianapolis, Indiana 46290, United States
University of Kansas Medical Center
Kansas City, Kansas 66160, United States
EMMC Northeast Cardiology Assocites
Bangor, Maine 04401, United States
University of Maryland School of Medicine
Baltimore, Maryland 21201, United States
Massachusetts General Hospital
Boston, Massachusetts 02114, United States
Heart Health Cardiology
Grand Rapids, Michigan 49546, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota 55407, United States
University of Minnesota
Minneapolis, Minnesota 55455, United States
Washington University School of Medicine
Saint Louis, Missouri 63110, United States
Mt Sinai Ichan Medical Institute
New York, New York 10029, United States
Duke University Medical Center
Durham, North Carolina 27710, United States
Rowan Diagnostic Clinic
Salisbury, North Carolina 28144, United States
Capital Area Research, LLC
Camp Hill, Pennsylvania 17011, United States
The University Of Texas Health Science Center Houston
Houston, Texas 77030, United States
San Antonio Premiere Internal Medicine
San Antonio, Texas 78220, United States
Clear Clinical Research, LLC
Schertz, Texas 78154, United States
PharmaTex Research
Tyler, Texas 75701, United States
Wasatch Clinical Research
Salt Lake City, Utah 84107, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales 2050, Australia
Redcliffe Hospital
Redcliffe, Queensland 1020, Australia
University Hospital Innsbruck - Tyrolean Hospital
Innsbruck, Tyrol 6020, Austria
Medizinische Universitaetsklinik Graz
Graz, A-8036, Austria
Robarts Research Institute
London, Ontario N6A 5B7, Canada
SKDS Research Inc.
Newmarket, Ontario L3Y 5G8, Canada
Centre Etudes Cliniques Econogene-21
Chicoutimi, Quebec G7H 7K9, Canada
Clinique des maladies lipidiques de Quebec
Québec, Quebec G1V 4W2, Canada
CCR Prague, S.R.O
Praha, Prague 3 13000, Czechia
Univerzita Karlova v Praze 1 Lekarska Fakulta
Karlov, Praha 2 121 08, Czechia
University Hospital, Charles University
Hradec Kralove, 50008, Czechia
Ikem Institut Klinicke A Experimentalni Mediciny
Prague, 14021, Czechia
Sydvestjysk Sygehus
Esbjerg, 6700, Denmark
Regionshospitalet Herning
Herning, 7400, Denmark
Hopital G Et R Laennec
Nantes, Cedex 44000, France
Houpital Du Bocage
Dijon, 21079, France
Edith Wolfson Medical Center
H̱olon, 58100, Israel
Galilee Medical Center
Nahariya, Israel
Sheba Mc
Ramat Gan, 5265601, Israel
Sourasky Medical Center, Cardiovascular Research Center
Tel Aviv, 64239, Israel
Azienda Ospedaliero Universitaria Federico II di Napoli
Napoli, 80131, Italy
Fondazione Toscana Gabriele Monasterio Per La Ricerca Medica E Di Sanita Pubblica
Pisa, 56126, Italy
Ausl Della Romagna-Ospedale Degli Infermi
Rimini, 47923, Italy
Dipartimento di Medicina Traslazionale e di Precisione dell'Università degli Studi di
Rome, 00185, Italy
Tokyo-Eki Center-building Clinic
Chuo-ku, 103-0027, Japan
Shonan Fujisawa Tokushukai Hospital
Fujisawa-shi, 251-0041, Japan
Minamino Cardiovascular Hospital
Hachioji, 192-0918, Japan
Saitama Medical University Hospital
Iruma-gun, 350-0495, Japan
Istishari Hospital
Amman, 11184, Jordan
King Abdullah University Hospital-1
Irbid, 22110, Jordan
King Abdullah University Hospital-2
Irbid, 22110, Jordan
King Abdullah University Hospital
Irbid, 22110, Jordan
VOC Hoorn
Hoorn, Hoorn Noord-Hollan 1624 NP, Netherlands
Admiraal de Ruyter Ziekenhuis
Goes, Zeeland 4462 RA, Netherlands
Academic Medical Center
Amsterdam, 1105 AZ, Netherlands
Universitair Medisch Centrum Utrech - Locatie AZU
Utrecht, Netherlands
Lipid and Diabetes Research Group
Christchurch, Canterbury 8011, New Zealand
Papamoa Pines Medical Centre
Papamoa, 3118, New Zealand
Clinical Horizons NZ Ltd
Tauranga, 3112, New Zealand
M3 Helse AS
Oslo, 0373, Norway
Halina Serafin NZOZ Centrum Medyczne SERAFIN-MED
Żarów, Dolnoslaskie 58-130, Poland
Nzoz Przychodnia Specjalistyczna
Ruda Slaska, Podlaskie 41709, Poland
Wojewodzki Szpital Specjalistyczny
Bytom, Poland
Slaskie Centrum Chorob Serca, III Katedra i Oddzial Kliniczny Kardiologii SUM- Oddzial Chorob Serca i Naczyn
Zabrze, 41-800, Poland
Federal State Budgetary Institution Research Institute for Complex Issues of Cardiovacsular Disease
Kemerovo, 65000, Russian Federation
National Research Center For Preventative Medicine of Federal Agency of High Technology Medical Aid
Moscow, 119990, Russian Federation
Federal State Budget Institution Out-patient Clinic 3
Moscow, 129090, Russian Federation
NII of Therapy and Preventive Medicine
Novosibirsk, 630089, Russian Federation
Municipal Medical and Prophylactic Institution - City Hospital for Emergency Care No.2
Rostov-on-Don, 34406, Russian Federation
Limmited Liability Company International Medical Centre SOGAZ
Saint Petersburg, 191186, Russian Federation
Federal State Institution of Healthcare Clinical Hospital #122 N.A.L.G Sokolov
Saint Petersburg, 194291, Russian Federation
LLC- Institute of Medical Research
Saint Petersburg, 196084, Russian Federation
Federal State Budgetary Institution Clinical-Diagnostic Center with Polyclinic
Saint Petersburg, 197110, Russian Federation
Samara Regional Clinical Cardiologic Dispensary
Samara, 443070, Russian Federation
Cardiology Research Institute
Tomsk, 34012, Russian Federation
The Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng 2000, South Africa
Jongaie Research
Pretoria, West Gauteng 182, South Africa
Dr JM Engelbrecht Trial Site
Cape Town, Western Cape 713, South Africa
University of Cape Town
Cape Town, 7925, South Africa
TREAD Research CC
Parow, 7500, South Africa
Hospital Universitario A Coruna
A Coruña, A Coruna 15001, Spain
Hospital Universitario Miguel Servet
Zaragoza, Aragon 50009, Spain
Hospital Universitario de Bellvitge
Barcelona, 08907, Spain
Hospital Universitario Reina Sofia
Córdoba, 14004, Spain
Hospital Universitario Virgen de las Nieves (HUVN)
Granada, 18014, Spain
Hospital Universitario Virgen del Rocio
Sevilla, 41013, Spain
Karolinska University Hospital
Malmö, Sweden
Akardo MedSite
Stockholm, 11446, Sweden
Karolinska Institutet
Stockholm, SE-182 88, Sweden
Akademiska sjukhuset
Uppsala, 75185, Sweden
Royal Free Hospital-Royal Free London NHS Foundation Trust
London, NW3 2QG, United Kingdom
Royal Victoria Infirmary - The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle Upon Tyne, NE1 4LP, United Kingdom

References and documents

Publications

Rosenson RS, Burgess LJ, Ebenbichler CF, Baum SJ, Stroes ESG, Ali S, Khilla N, Hamlin R, Pordy R, Dong Y, Son V, Gaudet D. Evinacumab in Patients with Refractory Hypercholesterolemia. N Engl J Med. 2020 Dec 10;383(24):2307-2319. doi: 10.1056/NEJMoa2031049. Epub 2020 Nov 15. PubMed 33196153 ↗

Study documents

Study protocol · Oct 11, 2019
Statistical analysis plan · Oct 18, 2019

Documents are hosted by the registry — open the source record to download them.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03175367
Lead sponsor: Regeneron Pharmaceuticals
Responsible party: Sponsor
First posted: Jun 5, 2017
Start date: Nov 10, 2017
Primary completion: May 22, 2020
Completion: Dec 14, 2020
Results posted: Feb 10, 2023
Last update: Feb 10, 2023

Study contacts

Clinical Trial Management

study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypercholesterolemia→

Other studies from this sponsor

Regeneron Pharmaceuticals

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