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A Phase 2 Pilot Study With a Randomized Double-Blind Treatment Phase to Evaluate the Pharmacodynamics and Safety of Alirocumab in Patients With Autosomal Dominant Hypercholesterolemia and Gain-of-Function Mutations in 1 or Both Alleles of the PCSK9 Gene or Loss-of-Function Mutations in 1 or More Alleles of the Loss-of-Function Mutations B Gene

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Trial Profile

A Phase 2 Pilot Study With a Randomized Double-Blind Treatment Phase to Evaluate the Pharmacodynamics and Safety of Alirocumab in Patients With Autosomal Dominant Hypercholesterolemia and Gain-of-Function Mutations in 1 or Both Alleles of the PCSK9 Gene or Loss-of-Function Mutations in 1 or More Alleles of the Loss-of-Function Mutations B Gene

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 03 Oct 2021

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At a glance

  • Drugs Alirocumab (Primary)
  • Indications Hyperlipoproteinaemia type IIa
  • Focus Pharmacodynamics
  • Sponsors Regeneron Pharmaceuticals

    • Most Recent Events

    • 27 Dec 2019 Long-term efficacy and safety results (n=23) of alirocumab in patients with PCSK9 GoFm and APOB LoFm in the open lable extension phase of the trial published in the American Journal of Cardiology.
    • 14 Nov 2018 Results presented at the 91st Annual Scientific Sessions of the American Heart Association
    • 29 Aug 2018 Results assessing the pharmacokinetics and pharmacodynamics of alirocumab in patients with apolipoprotein B loss-of-function mutations versus patients with PCSK9 gain-of-function mutations, presented at the ESC Congress 2018: Annual Congress of the European Society of Cardiology.

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