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A Two-Part (Double-Blind Placebo Controlled/Open-Label) Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Subjects With Homozygous Familial Hypercholesterolemia (HoFH) (ORION-5)

Trial Profile

A Two-Part (Double-Blind Placebo Controlled/Open-Label) Multicenter Study to Evaluate Safety, Tolerability, and Efficacy of Inclisiran in Subjects With Homozygous Familial Hypercholesterolemia (HoFH) (ORION-5)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Dec 2023

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At a glance

  • Drugs Inclisiran (Primary)
  • Indications Hypercholesterolaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms ORION-5
  • Sponsors Novartis Pharmaceuticals; The Medicines Company
  • Most Recent Events

    • 12 Dec 2023 Results of post hoc analysis assessing the safety and tolerability of inclisiran for treatment of hypercholesterolemia from completed (ORION-1, -3, -5, -9, -10, and -11) and ongoing (ORION-8) trials, published in the Journal of the American College of Cardiology.
    • 18 Oct 2023 Primary endpoint has not been met. (Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) from Baseline to Day 150), as per Results published in the Circulation
    • 18 Oct 2023 Results published in the Circulation
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