A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)
NCT05500222Phase 3Active, not recruiting
- Lead sponsor
- Madrigal Pharmaceuticals, Inc. (Industry)
- Enrollment
- 845 (estimated)
- Start date
- 26 Aug 2022
- Primary completion
- Dec 2026 (estimated)
- Study completion
- 1 Jan 2027
- Last update posted
- 8 Jul 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Triple
- Arms
- 2
Interventions
- Resmetirom Drug
- Placebo Drug
Conditions and primary outcome
- NASH
- Cirrhosis, Liver
Primary outcome
Incidence Of adjudicated Composite Clinical Outcome event (Baseline up to Month 36)
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
- NCT05500222 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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