A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Non Alcoholic Fatty Liver Disease Patients
NCT04197479 · MAESTRO-NAFLD1 Phase 3Completed
- Lead sponsor
- Madrigal Pharmaceuticals, Inc. (Industry)
- Enrollment
- 1,343 (actual)
- Start date
- 16 Dec 2019
- Primary completion
- 6 Jan 2023 (actual)
- Study completion
- 6 Jan 2023
- Last update posted
- 5 Sep 2023
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Quadruple
- Arms
- 4
Interventions
- Placebo Drug
- Resmetirom Drug
Conditions and primary outcome
- Non-Alcoholic Fatty Liver Disease
Primary outcome
The effect of once daily, oral administration of 80 or 100 mg resmetirom versus placebo 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
4 on PubMedSelf-Reported Cognitive Function in Metabolic Dysfunction-associated Steatotic Liver Disease and Metabolic Dysfunction-associated Steatohepatitis: A Post-hoc Analysis of the MAESTRO Resmetirom Trials.
Journal of clinical and experimental hepatology · 2026 Jul-Aug
PubMed 41953252 (opens in a new tab)DOI 10.1016/j.jceh.2026.103531 (opens in a new tab)
The Cholate Challenge Test Quantified Baseline Functional Heterogeneity and Improvement in Response to Resmetirom in MASH-related Child-Pugh A Cirrhosis.
Gastro hep advances · 2025
PubMed 41142528 (opens in a new tab)DOI 10.1016/j.gastha.2025.100785 (opens in a new tab)
Design 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)
Resmetirom for nonalcoholic fatty liver disease: a randomized, double-blind, placebo-controlled phase 3 trial.
Nature medicine · 2023 Nov
PubMed 37845512 (opens in a new tab)DOI 10.1038/s41591-023-02603-1 (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
- NCT04197479 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.
Nothing on this page is medical or investment advice.