NCT03175367

Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia

A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Varying Doses and Dose Regimens of Evinacumab in Patients With Persistent Hypercholesterolemia Despite Maximally Tolerated Lipid Modifying Therapy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 272 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Evinacumab	SC or IV administration
DRUG	Matching placebo	SC or IV administration
OTHER	Background 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.

Timeline

• Start date: 2017-11-10
• Primary completion: 2020-05-22
• Completion: 2020-12-14
• First posted: 2017-06-05
• Last updated: 2023-02-10
• Results posted: 2023-02-10

Locations

95 sites across 20 countries: United States, Australia, Austria, Canada, Czechia, Denmark, France, Israel, Italy, Japan, Jordan, Netherlands, New Zealand, Norway, Poland, Russia, South Africa, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study