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A Double-blind, Randomized, Placebo- and Active-Comparator Controlled Study to Evaluate the Efficacy of Inclisiran as Monotherapy in Patients with Primary Hypercholesterolemia Not Receiving Lipid-Lowering Therapy (VictORION-Mono)

Trial Profile

A Double-blind, Randomized, Placebo- and Active-Comparator Controlled Study to Evaluate the Efficacy of Inclisiran as Monotherapy in Patients with Primary Hypercholesterolemia Not Receiving Lipid-Lowering Therapy (VictORION-Mono)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 04 Oct 2024

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At a glance

  • Drugs Inclisiran (Primary) ; Ezetimibe
  • Indications Hypercholesterolaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms V-Mono; VictORION-Mono
  • Sponsors Novartis; Novartis Pharmaceuticals
  • Most Recent Events

    • 28 Aug 2024 According to Novartis media release, the company plans to present results from this trial at an upcoming medical meeting and share with regulatory agencies including the US Food and Drug Administration (FDA).
    • 28 Aug 2024 Primary endpoint has been met. (Percentage change in LDL-C from Baseline to Day 150 compared with ezetimibe)
    • 28 Aug 2024 Primary endpoint has been met. (Percentage change in Low-density Lipoprotein Cholesterol (LDL-C) from Baseline to Day 150 compared with placebo)

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