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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 HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HeFH) 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 HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA (HeFH) 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 Hyperlipoproteinaemia type IIa
  • Focus Registrational; Therapeutic Use
  • Acronyms ORION-9
  • 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.
    • 04 Nov 2022 Results of pooled analysis of ORION-9, 10 and 11 trials assessing inclisiran and cardiovascular events were published in the European Heart Journal.
    • 22 Dec 2021 According to Novartis media release, the US Food and Drug Administration (FDA) has approved Leqvio (inclisiran) to lower low-density lipoprotein cholesterol (also known as bad cholesterol or LDL-C) with two doses a year, after an initial dose and one at three months, based on data from ORION-9, -10 and -11 trials.
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