A Phase 3 Study 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)
NCT04951219Phase 3Active, not recruiting
- Lead sponsor
- Madrigal Pharmaceuticals, Inc. (Industry)
- Enrollment
- 810 (actual)
- Start date
- 9 Jul 2021
- Primary completion
- Mar 2027 (estimated)
- Study completion
- 1 Apr 2027
- Last update posted
- 27 May 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Triple
- Arms
- 6
Interventions
- Resmetirom Drug
Conditions and primary outcome
- Non-Alcoholic Fatty Liver Disease
Primary outcome
The effect of once daily, oral administration of resmetirom on the incidence of adverse events. (52 weeks)
Posted results on ClinicalTrials.gov
Results posted on ClinicalTrials.gov: No
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
1 on PubMedDesign of the phase 3 MAESTRO clinical program to evaluate resmetirom for the treatment of nonalcoholic steatohepatitis.
Alimentary pharmacology & therapeutics · 2024 Jan
PubMed 37786277 (opens in a new tab)DOI 10.1111/apt.17734 (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT04951219 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
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