MedTrace Logo

Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia

NCT03175367 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2023-02-10

Study results available
· View outcomes & findings →

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-10
Primary Completion
2020-05-22
Completion
2020-12-14
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03175367 on ClinicalTrials.gov