A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
NCT03900429 · MAESTRO-NASH Phase 3Active, not recruiting
- Lead sponsor
- Madrigal Pharmaceuticals, Inc. (Industry)
- Enrollment
- 1,759 (actual)
- Start date
- 28 Mar 2019
- Primary completion
- Jan 2028 (estimated)
- Study completion
- 1 Jan 2028
- Last update posted
- 1 Jun 2026
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Quadruple
- Arms
- 3
Interventions
- MGL-3196 Drug
- Placebo Drug
- Liver Biopsy Procedure
Conditions and primary outcome
- NASH - Nonalcoholic Steatohepatitis
Primary outcome
Week 52 Dual Primary Objectives: To determine the effect of 80 or 100 mg MGL-3196 vs matching placebo on liver biopsy (NASH CRN score) at Week 52 compared with Baseline (52 weeks); Month 54 Primary Objective: Time to experiencing an adjudicated Composite Clinical Outcome event (Final Primary Endpoint, at 54 months) (up to 54 months)
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
7 on PubMedEffects of MASH risk genotypes on resmetirom efficacy in patients with MASH and fibrosis.
Journal of hepatology · 2026 Oct 5
PubMed 42833311 (opens in a new tab)DOI 10.1016/j.jhep.2026.08.037 (opens in a new tab)
Quantitative regression of qFibrosis with resmetirom: Exploratory histologic endpoints from the MAESTRO-NASH phase III clinical trial.
Journal of hepatology · 2026 Aug
PubMed 41895606 (opens in a new tab)DOI 10.1016/j.jhep.2026.03.021 (opens in a new tab)
Effects of Resmetirom on Metabolic-Dysfunction Associated Steatohepatitis in Patients With Weight Loss and/or Diabetes Taking Glucagon-Like Peptide-1 Receptor Agonists and Other Diabetes Therapies: A Secondary Analysis of the MAESTRO-NASH Trial.
Alimentary pharmacology & therapeutics · 2025 Dec
PubMed 41127972 (opens in a new tab)DOI 10.1111/apt.70382 (opens in a new tab)
Health-related quality of life (HRQL) assessments in a 52-week, double-blind, randomized, placebo-controlled phase III study of resmetirom (MGL-3196) in patients with metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis.
Hepatology (Baltimore, Md.) · 2025 Apr 1
PubMed 39250515 (opens in a new tab)DOI 10.1097/HEP.0000000000001084 (opens in a new tab)
A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis.
The New England journal of medicine · 2024 Feb 8
PubMed 38324483 (opens in a new tab)DOI 10.1056/NEJMoa2309000 (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)
Effects of Resmetirom on Noninvasive Endpoints in a 36-Week Phase 2 Active Treatment Extension Study in Patients With NASH.
Hepatology communications · 2021 Apr
PubMed 33860116 (opens in a new tab)DOI 10.1002/hep4.1657 (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.
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Source
- NCT03900429 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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