Study in Participants With Homozygous Familial Hypercholesterolemia (HoFH)

  • STATUS
    Not Recruiting
  • participants needed
    74
  • sponsor
    Regeneron Pharmaceuticals
Updated on 20 June 2021

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

Details
Condition Homozygous Familial Hypercholesterolemia
Treatment Placebo, alirocumab
Clinical Study IdentifierNCT03156621
SponsorRegeneron Pharmaceuticals
Last Modified on20 June 2021

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