Study of Evinacumab (REGN1500) in Participants With Persistent Hypercholesterolemia
Completed · Phase 2 · Has a placebo group
Conditions studied: Hypercholesterolemia
In brief
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.
Key facts
- Study ID
- NCT03175367
- Run by
- Regeneron Pharmaceuticals
- People needed
- 272
- Starts
- 2017-11-10
- Expected to finish
- 2020-12-14
- Last updated by the study team
- 2023-02-10
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Office of Dr. John D Homan MD — Newport Beach, California, United States
- Preventive Cardiology Inc — Boca Raton, Florida, United States
- Care Research Center Inc — Doral, Florida, United States
- Florida Lipid Institute — Winter Park, Florida, United States
- St. Vincent Medical Group, Inc — Indianapolis, Indiana, United States
- University of Kansas Medical Center — Kansas City, Kansas, United States
- EMMC Northeast Cardiology Assocites — Bangor, Maine, United States
- University of Maryland School of Medicine — Baltimore, Maryland, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Heart Health Cardiology — Grand Rapids, Michigan, United States
- Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
- University of Minnesota — Minneapolis, Minnesota, United States
- Washington University School of Medicine — St Louis, Missouri, United States
- Mt Sinai Ichan Medical Institute — New York, New York, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Rowan Diagnostic Clinic — Salisbury, North Carolina, United States
- Capital Area Research, LLC — Camp Hill, Pennsylvania, United States
- The University Of Texas Health Science Center Houston — Houston, Texas, United States
- San Antonio Premiere Internal Medicine — San Antonio, Texas, United States
- Clear Clinical Research, LLC — Schertz, Texas, United States
- PharmaTex Research — Tyler, Texas, United States
- Wasatch Clinical Research — Salt Lake City, Utah, United States
- Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
- Redcliffe Hospital — Redcliffe, Queensland, Australia
- Cedars-Sinai Medical Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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