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)
Latest Information Update: 19 Jul 2024
At a glance
- Drugs Resmetirom (Primary)
- Indications Non-alcoholic fatty liver disease
- Focus Adverse reactions; Registrational
- Acronyms MAESTRO-NAFLD-OLE
- Sponsors Madrigal Pharmaceuticals
- 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.