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A 52-Week, Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD) (MAESTRO-NAFLD-1)

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Trial Profile

A 52-Week, Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD) (MAESTRO-NAFLD-1)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 May 2025

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At a glance

  • Drugs Resmetirom (Primary)
  • Indications Non-alcoholic fatty liver disease; Non-alcoholic steatohepatitis
  • Focus Adverse reactions; Registrational
  • Acronyms MAESTRO-NAFLD-1
  • Sponsors Madrigal Pharmaceuticals

Most Recent Events

  • 10 May 2025 Results (n=122) achieving significant improvements from baseline in liver stiffness, liver fat, fibrosis biomarkers, liver volume and risk scores for clinically significant portal hypertension (CSPH) were published in the Madrigal media release.
  • 29 Apr 2025 According to a Madrigal media release, at 8 a.m. EDT May 13, 2025, Madrigal will host a webcast to review the detailed two-year data from the compensated MASH cirrhosis (F4c) arm of the Phase 3 MAESTRO-NAFLD-1 trial.
  • 29 Apr 2025 According to a Madrigal media release, two-year data from this study will be presented at the at upcoming European Association for the Study of Liver (EASL) Congress being held May 7-10, 2025.

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