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

• Status: Completed
• Trial end date: 2018-07-23
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals

Criteria

Inclusion Criteria:

1. Men and women ≥18 years of age at the time of the screening visit

2. Diagnosis of homozygous familial hypercholesterolemia (HoFH)

3. Willing to consistently maintain usual diet for the duration of the study

Exclusion Criteria:

1. Background medical lipid modifying therapy that has not been stable for at least 4 weeks (6 weeks for fibrates) prior to the screening visit

2. Having undergone lipid apheresis within 4 weeks prior to the screening visit

3. Use of another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer) prior to the screening visit

4. 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.