Regeneron 1331 Kinetics Sub-Study HoFH
- Conditions
- Hypercholesterolemia, Familial
- Interventions
- Other: Kinetics test
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Volunteers with known HoFH and particpated in R1500-CL-1331 clinical trial Kinetics test -
- 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Department of Vascular Medicine Amsterdam UMC
🇳🇱Amsterdam, AZ, Netherlands