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)

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)

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Jun 2018

At a glance

  • Drugs Inclisiran (Primary)
  • Indications Hypercholesterolaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms ORION-11
  • Sponsors The Medicines Company
  • Most Recent Events

    • 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.
    • 08 Mar 2018 According to The Medicines Company media release, data read-out expected in Q3/2019.
    • 25 Feb 2018 The trial has been discontinued in Netherlands.
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