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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)

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)

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 23 Dec 2018

At a glance

  • Drugs Inclisiran (Primary)
  • Indications Hypercholesterolaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms ORION-9
  • Sponsors The Medicines Company
  • Most Recent Events

    • 01 Oct 2018 According to The Medicines Company media release, data read-out expected in Q2/2019.
    • 31 Aug 2018 Biomarkers information updated
    • 27 Jun 2018 According to The Medicines Company media release, the Independent Data Monitoring Committee (IDMC) under a planned review of the ongoing inclisiran Phase III trials- ORION-9, ORION-10 and ORION-11, has recommended that the trials continue as designed and conducted, without modification. The IDMC's recommendation was based on its review of unblinded safety and efficacy data from the trials.
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