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A Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Atherosclerotic Cardiovascular Disease (ASCVD) or ACSVD Risk-Equivalents and Elevated Low-Density Lipoprotein Cholesterol (LDL-C)

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Trial Profile

A Placebo-Controlled, Double-Blind, Randomized Trial to Evaluate the Effect of 300 mg of Inclisiran Sodium Given as Subcutaneous Injections in Subjects With Atherosclerotic Cardiovascular Disease (ASCVD) or ACSVD Risk-Equivalents and Elevated Low-Density Lipoprotein Cholesterol (LDL-C)

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-11
  • Sponsors 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.
    • 01 Dec 2023 Results of pooled analysis from ORION-10 and ORION-11 , evaluating in patients with or without prior MI, published in the Atherosclerosis
    • 04 Nov 2022 Results of pre-specified analysis evaluating Effect of inclisiran on lipids in primary prevention, published in the European Heart Journal
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