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

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Homozygous Familial Hypercholesterolemia

Treatments: Drug: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT02265952

R1500-CL-1331

2016-000411-32 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Open-label

Experimental group

Description:

Open-label REGN1500

Treatment:

Drug: REGN1500 250 mg SC/15 mg/kg IV/450 mg SC