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A 52-Week, Phase 3, Open-Label Extension Study, With a Single-blind Lead-in, to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)

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Trial Profile

A 52-Week, Phase 3, Open-Label Extension Study, With a Single-blind Lead-in, to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Jul 2024

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At a glance

  • Drugs Resmetirom (Primary)
  • Indications Non-alcoholic fatty liver disease
  • Focus Adverse reactions; Registrational
  • Acronyms MAESTRO-NAFLD-OLE
  • 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
    • 28 Nov 2023 Planned End Date changed from 1 Apr 2024 to 1 Apr 2026.
    • 28 Nov 2023 Planned primary completion date changed from 1 Apr 2024 to 1 Mar 2026.

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