Regeneron 1331 Kinetics Sub-Study HoFH

Not Applicable

Completed

• Conditions: Hypercholesterolemia, Familial

• Registration Number: NCT04722068
• Lead Sponsor: University of Pennsylvania

Brief Summary

To evaluate the lipoprotein kinetics of subjects enrolled in the R1500-CL-1331 clinical trial (NCT02265952) to assess the mechanism by which the evinacumab may affect lipid levels in HoFH subjects.

Detailed Description

Subjects enrolled in the R1500-CL-1331 clinical trial (NCT0226595) will participate in a study visit before and after administration of the ANGPTL3 inhibitor REGN1500, evinacumab) for the evaluation of its effect on lipoprotein kinetics.

Study Timeline

• Study Start: 2016-10-07
• Primary Completion: 2016-11-30
• Study Completion: 2021-01-01
• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-19
• Study First Posted: 2021-01-25
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-14
• Last Update Posted: 2021-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Production rate (PR) of lipoproteins mg/kg/day	completion of study, average of 8 weeks	First visit to be performed prior to first evinacumab administration; second visit to be performed approximately 4-6 weeks after evinacumab i.v. administration. About 8 weeks between the 2 visits.
Fractional catabolic rate (FCR) pools/day	completion of study, average of 8 weeks	First visit to be performed prior to first evinacumab administration; second visit to be performed approximately 4-6 weeks after evinacumab i.v. administration. About 8 weeks between the 2 visits.

Trial Locations

Locations (2)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Department of Vascular Medicine Amsterdam UMC; 🇳🇱 Amsterdam, AZ, Netherlands