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A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

Trial Profile

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Evinacumab in Patients With Homozygous Familial Hypercholesterolemia

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Dec 2023

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At a glance

  • Drugs Evinacumab (Primary) ; Alirocumab
  • Indications Hyperlipoproteinaemia type IIa
  • Focus Registrational; Therapeutic Use
  • Acronyms ELIPSE HoFH
  • Sponsors Regeneron Pharmaceuticals
  • Most Recent Events

    • 30 Nov 2023 Results of a mathematical modelling analysis performed using data from this trial published in the European Journal of Preventive Cardiology
    • 17 May 2021 Patients with null/null LDLR variants (n=2) from this study were included to evaluate the LDL cholesterol lowering effect of evinacumab, presented at the 70th Annual Scientific Session of the American College of Cardiology.
    • 11 Feb 2021 According to an Regeneron Pharmaceuticals media release, the U.S. Food and Drug Administration (FDA) approved EvkeezaTM (evinacumab-dgnb) as an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies to treat adult and pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH), based on data from this trial.
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