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A long term extension trial of the Phase III lipid-lowering trials to assess the effect of long term dosing of inclisiran given as subcutaneous injections in subjects with high cardiovascular risk and elevated LDL-C (ORION-8)

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A long term extension trial of the Phase III lipid-lowering trials to assess the effect of long term dosing of inclisiran given as subcutaneous injections in subjects with high cardiovascular risk and elevated LDL-C (ORION-8)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 31 Oct 2024

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At a glance

  • Drugs Inclisiran (Primary)
  • Indications Hypercholesterolaemia
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ORION-8
  • Sponsors Novartis

    • Most Recent Events

    • 14 Oct 2024 Results assessing the long-term efficacy and tolerability of inclisiran were published in the Cardiovascular Research.
    • 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.
    • 28 Aug 2023 According to Novartis media release, long-term results were presented in a late-breaking session at the European Society of Cardiology (ESC) Congress 2023 in Amsterdam.

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