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An Adaptive Two-Part Phase 2, Multi-Center, Randomized, Double Blind, Placebo-Controlled Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of ION224 Administered Once Monthly in Adult Subjects With Confirmed Non-Alcoholic Steatohepatitis

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Trial Profile

An Adaptive Two-Part Phase 2, Multi-Center, Randomized, Double Blind, Placebo-Controlled Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of ION224 Administered Once Monthly in Adult Subjects With Confirmed Non-Alcoholic Steatohepatitis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 13 Aug 2024

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At a glance

  • Drugs IONIS DGAT2Rx (Primary)
  • Indications Non-alcoholic steatohepatitis
  • Focus Therapeutic Use
  • Sponsors Ionis Pharmaceuticals

    • Most Recent Events

    • 27 Mar 2024 Status changed from active, no longer recruiting to completed.
    • 13 Mar 2024 According to an Ionis Pharmaceuticals media release, the company look forward sharing the full results from this study at an upcoming medical conference.
    • 13 Mar 2024 Primary endpoint has been met. (Percentage of Participants With at Least 2-point Reduction in Non-alcoholic Fatty Liver Disease Activity Score (NAS) With at least 1-point Improvement in Hepatocellular Ballooning or Lobular Inflammation, and Without Worsening in Fibrosis Stage at EOT), according to an Ionis Pharmaceuticals media release.

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