AN OPEN-LABEL, SINGLE-ARM, PROOF-OF-CONCEPT STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SINGLE AND MULTIPLE DOSES OF REGN1500 IN PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
- Conditions
- hereditary abnormal high cholesterol levelhomozygous familial hypercholesterolemia1008362410013317
- Registration Number
- NL-OMON43236
- Lead Sponsor
- Regeneron Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2
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;
Please refer to the Protocl for a full list of Inclusion criteria.
1. Background medical lipid modifying therapy that has not been stable for at leat 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
Please refer to the Protocl for a full list of Exclusion criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint in the study is the percent change in LDL-C from baseline<br /><br>(week 0) to week 4.</p><br>
- Secondary Outcome Measures
Name Time Method