A cardiovascular outcomes trial in subjects with ASCVD and/or risk equivalents, such as diabetes, to determine the effects of LDL-C lowering with inclisiran on cardiovascular outcomes

Trial Profile

A cardiovascular outcomes trial in subjects with ASCVD and/or risk equivalents, such as diabetes, to determine the effects of LDL-C lowering with inclisiran on cardiovascular outcomes

Planning
Phase of Trial: Phase III

Latest Information Update: 25 Jan 2018

At a glance

  • Drugs Inclisiran (Primary)
  • Indications Hypercholesterolaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms ORION-4
  • Sponsors The Medicines Company
  • Most Recent Events

    • 25 Jan 2018 According to The Medicines Company media release, the company anticipate completion of the trial to include the results in an NDA planned for the end of 2019.
    • 25 Jan 2018 According to The Medicines Company media release, following 6 months of treatment to provide data for HoFH as part of a comprehensive LDL-C lowering program in a planned NDA and MAA submission.
    • 07 Jan 2018 According to an Alnylam Pharmaceuticals media release, the company expects to initiate enrollment in this trial in mid-2018.
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