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A Phase 3, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With Nonalcoholic Steatohepatitis (NASH) With Open-Label Part to Evaluate the Safety, PK and Treatment Response Kinetics of Aramchol. The ARMOR Study

Trial Profile

A Phase 3, Multinational, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With Nonalcoholic Steatohepatitis (NASH) With Open-Label Part to Evaluate the Safety, PK and Treatment Response Kinetics of Aramchol. The ARMOR Study

Status: Suspended
Phase of Trial: Phase III

Latest Information Update: 16 Oct 2023

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At a glance

  • Drugs Icomidocholic acid (Primary)
  • Indications Hepatic fibrosis; Non-alcoholic steatohepatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms ARMOR
  • Sponsors Galmed Research and Development, Ltd.
  • Most Recent Events

    • 15 Oct 2023 The trial has been discontinued in Spain, according to European Clinical Trials Database
    • 04 Jan 2023 According to a Galmed Pharmaceuticals media release, the company has no plans to start the Double-Blind part of the study.
    • 04 Jan 2023 Open-Label Part results (n=157) published in a Galmed Pharmaceuticals media release.
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