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Evaluating Resmetirom for Patients with NASH Cirrhosis

A Randomized Double-blind Placebo-controlled Phase 3 Study to Evaluate the Effect of Resmetirom on Liver-related Outcomes in Patients With Well-compensated (Child-Pugh A) Non-alcoholic Steatohepatitis (NASH) Cirrhosis (MAESTRO-NASH-OUTCOMES)

Phase 3 Interventional Madrigal Pharmaceuticals, Inc. · NCT05500222

This study is testing if a daily pill called resmetirom can help people with NASH cirrhosis live longer and avoid serious liver problems.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment700 (estimated)
Ages18 Years and up
SexAll
SponsorMadrigal Pharmaceuticals, Inc. Industry-sponsored
Locations55 sites (Birmingham, Alabama and 54 other locations)
Trial IDNCT05500222 on ClinicalTrials.gov

What this trial studies

This Phase 3 study investigates the effects of oral 80 mg resmetirom taken once daily on patients with well-compensated non-alcoholic steatohepatitis (NASH) cirrhosis. It is a multi-national, multicenter, double-blind, randomized, placebo-controlled trial designed to measure the time until participants experience a Composite Clinical Outcome event, which includes liver-related mortality, liver transplant, and significant hepatic events. Participants will be randomly assigned to receive either resmetirom or a matching placebo for approximately three years, following a 60-day screening period.

Who should consider this trial

Good fit: Ideal candidates are individuals with well-compensated NASH cirrhosis confirmed by histological documentation or MRI-PDFF.

Not a fit: Patients with cirrhosis not caused by NASH or those with advanced liver disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve clinical outcomes for patients suffering from NASH cirrhosis.

How similar studies have performed: Previous studies have shown promise in treating NASH, but this specific approach with resmetirom is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Definitive (by histologic documentation) or probable NASH as causative agent for cirrhosis, following a modified version of the NASH Cirrhosis: Liver Forum Consensus Definitions for Clinical Trials.
* a. Most recent biopsy (within last 5 years) shows cirrhosis with a NAS of ≥ 2, and at least two components: one being steatosis and at least one other component; OR NAS of ≥ 2, if steatosis = 0 or is ungraded with inflammation and/or ballooning, eligible with an MRI-PDFF \>5%. If steatosis and ballooning and/or steatosis and inflammation are noted by the local pathologist, then the biopsy qualifies even if a NAS is not provided (Approximately 70% of the study patient population) b. Historical biopsy (within last 5 years) showed NASH with significant fibrosis with pathology report documenting "F2" or "F3", with at least steatosis either by biopsy with no minimal percentage required or by MRI-PDFF \>5%, AND inflammation or ballooning. Now with cirrhosis, either by clinical history or current features, imaging, noninvasive tests, or biopsy (see Appendix 7) (Up to approximately 20% of study patient population) c. Historical biopsy (within last 5 years) shows steatosis. Pathology report documents steatosis with no minimal percentage required. Now with cirrhosis, either by clinical history or current features, imaging, noninvasive tests, or biopsy (see Appendix 7). Prescreening metabolic risk factors must include obesity and/or T2D. (Up to approximately 10% of study patient population.)
* Well-compensated NASH cirrhosis at screening and baseline with Child-Pugh A (score of 5-6) (no history of hepatic decompensation event).
* At least 3 metabolic risk factors
* Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) that is obtained during the Screening period or a historic MRI-PDFF at ≤8 weeks old at the time of randomization with no weight change ≥5% weight change in that interval.
* MRE ≥4.2 where MRE is available.
* Enhanced liver function (ELF) ≥9.8, only if MRE is unavailable or contraindicated.

Exclusion Criteria:

* Participants with a chronic liver diseases other than NASH cirrhosis, such as primary biliary cholangitis, primary sclerosing cholangitis, Hepatitis B positive, Hepatitis C, history or evidence of current active autoimmune hepatitis, history or evidence of Wilson's disease, history or evidence of alpha-1-antitrypsin deficiency, history or evidence of genetic hemochromatosis (hereditary, primary), evidence of drug-induced liver disease, as defined on the basis of typical exposure and history, known bile duct obstruction, or suspected or confirmed liver cancer, are excluded.
* Participants with MELD score ≥12 due to liver disease are excluded.
* Participants with a history of hepatic decompensation or impairment are excluded.

Where this trial is running

Birmingham, Alabama and 54 other locations

+5 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions NASHCirrhosis, Liver
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.