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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)

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: 22 Mar 2024

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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

    • 14 Mar 2024 According to Food and Drug Administration media release, the Food and Drug Administration (FDA) granted accelerated approval of a first of its kind drug therapy, resmetirom, for the treatment of nonalcoholic steatohepatitis (NASH) in patients who have progressed to fibrosis
    • 14 Nov 2023 Results (n=34) determining whether these NEXT GENER-ATION (NGEN) HepQuant Tests, using Risk ACE as endpoint, could detect treatment effects in MAESTRO-NAFLD-1, an open label, single arm study of resmetirom, studied for the treatment of NASH presented at The Liver Meeting 2023: 74th Annual Meeting of the American Association for the Study of Liver Diseases
    • 06 Nov 2023 According to a Madrigal Pharmaceuticals media release, data from this study were published in Nature Medicine.
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