Completed
PHASE2
INTERVENTIONAL
NCT03175367
Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief 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.
Interventions
Name:
Evinacumab
Type:
DRUG
Description:
SC or IV administration
Name:
Matching placebo
Type:
DRUG
Description:
SC or IV administration
Name:
Background Lipid Modifying Therapy (LMT)
Type:
OTHER
Description:
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.
Primary Outcomes
Measure:
Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 16 (Intent-to-Treat [ITT] Estimand)
TimeFrame:
Baseline and Week 16
Description:
Trial Information
NCT ID
NCT03175367
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2
Sponsor
Regeneron Pharmaceuticals
Last Updated
December 15, 2025