Study of REGN1500 in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

Completed · Phase 2

Conditions studied: Homozygous Familial Hypercholesterolemia

In brief

This is an open-label, single-arm study to assess the reduction of low-density lipoprotein cholesterol (LDL-C) by REGN1500 in patients with homozygous familial hypercholesterolemia (HoFH).

Key facts

Study ID

NCT02265952

Run by

Regeneron Pharmaceuticals

People needed

9

Starts

2015-02-04

Expected to finish

2018-07-23

Last updated by the study team

2019-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women ≥18 years of age at the time of the screening visit
• Diagnosis of homozygous familial hypercholesterolemia (HoFH)
• Willing to consistently maintain usual diet for the duration of the study

You may not qualify if…

• Background medical lipid modifying therapy that has not been stable for at least 4 weeks (6 weeks for fibrates) prior to the screening visit
• Having undergone lipid apheresis within 4 weeks prior to the screening visit
• Use of another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer) prior to the screening visit
• Previous participation in any clinical trial of REGN1500
• Note: The information listed above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial therefore not all inclusion/ exclusion criteria are listed.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Dallas, Texas, United States
• Study site — Chicoutimi, Quebec, Canada
• Study site — Amsterdam, Netherlands

Full record on ClinicalTrials.gov

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