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A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (Resmetirom) in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation

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Trial Profile

A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (Resmetirom) in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 12 Apr 2024

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At a glance

  • Drugs Resmetirom (Primary)
  • Indications Fibrosis; Non-alcoholic steatohepatitis
  • Focus Registrational; Therapeutic Use
  • Acronyms MAESTRO-NASH
  • Sponsors Madrigal Pharmaceuticals

    • Most Recent Events

    • 09 Apr 2024 According to a Madrigal Pharmaceuticals media release, company announced that Rezdiffra (resmetirom) is now available in the U.S. Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.
    • 14 Mar 2024 According to a Madrigal Pharmaceuticals media release, the U.S. Food and Drug Administration approved Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), to be used along with diet and exercise. The accelerated approval of Rezdiffra was based on results from this Phase 3 MAESTRO-NASH trial.
    • 05 Mar 2024 According to a Madrigal Pharmaceuticals media release, company announced that the Company's Marketing Authorization Application (MAA) for resmetirom for the treatment of NASH/metabolic dysfunction-associated steatohepatitis (MASH) with liver fibrosis has been validated and is now under evaluation with the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). MAA submission is supported by positive results from MAESTRO-NASH and 18 clinical studies.
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