Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)
Status:
Completed
Trial end date:
2020-02-13
Target enrollment:
Participant gender:
Summary
The primary objective of the study is to demonstrate the reduction of low-density lipoprotein
cholesterol (LDL-C) with alirocumab subcutaneous (SC) every 2 weeks (Q2W) in comparison to
placebo after 12 weeks of treatment.
The secondary objectives of the study are:
- To evaluate the effect of alirocumab Q2W on other lipid parameters (ie, apolipoprotein
[Apo] A-1 and B, non-high-density lipoprotein cholesterol [non-HDL-C], total-cholesterol
[TC], proportion of participants with 15%, 30%, and 50% LDL-C reductions, Lp(a), HDL-C,
triglycerides [TG]) in participants with HoFH
- To evaluate the safety and tolerability of alirocumab SC Q2W in participants with HoFH
- To assess the pharmacokinetics of alirocumab SC Q2W in participants with HoFH
- To assess the potential development of anti-drug (alirocumab) antibodies