A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: NASH, Cirrhosis, Liver

In brief

This study will determine the effect of oral 80 mg resmetirom administered once daily on participants with well-compensated non-alcoholic steatohepatitis (NASH) cirrhosis by measuring the time to experiencing a Composite Clinical Outcome event.

Key facts

Study ID

NCT05500222

Run by

Madrigal Pharmaceuticals, Inc.

People needed

845

Starts

2022-08-26

Expected to finish

2027-01-01

Last updated by the study team

2026-07-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A clinical diagnosis of NASH cirrhosis
• At least 3 metabolic risk factors
• Historical liver biopsy read as consistent with NASH cirrhosis.
• Historical biopsy consistent with NASH with significant fibrosis, now with progression to cirrhosis. Or, no historical biopsy, with a clinical picture of NASH cirrhosis.
• Well-compensated Child-Pugh A (score of 5-6) cirrhosis at Screening and Baseline
• No history of a hepatic decompensation event.
• MRE ≥4.2 obtained during the screening period (if MRE is <4.2 and ≥3.7, then an ELF ≥10.25 OR platelet counts <140K obtained during the screening period is required for eligibility)

You may not qualify if…

• 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
• Participants with MELD score ≥12 due to liver disease are excluded.
• Participants with a history of hepatic decompensation or impairment are excluded
• Diagnosis of hepatocellular carcinoma (HCC) at Screening or historically
• Liver Imaging Reporting and Data System (LI-RADS) score ≥4 at Screening
• No history of alcohol-related liver disease or history (within 5 years) of excessive alcohol consumption
• Weight gain or loss ≥5% total body weight within 12 weeks prior to randomization
• PEth value of ≥20 ng/mL measured at Screening
• HbA1c >9.0%
• Platelet counts <70,000/mm3 at either screening or baseline
• Use of high dose vitamin E (>400 IU/day) unless stable for ≥6 months prior to randomization
• Use of pioglitazone >15 mg per day
• Glucagon-like peptide 1 (GLP-1) agonist therapy for diabetes treatment must be a stable dose for at least 12 weeks prior to randomization. GLP-1 agonists for weight loss must be at stable doses for at least 6 months (including body weight change ≥ 5% weight loss in the 12 weeks prior to randomization)

Where it is running

• Arizona Liver Health - Chandler — Chandler, Arizona, United States
• Arizona Liver Health - Peoria — Peoria, Arizona, United States
• Adobe Clinical Research — Tucson, Arizona, United States
• Arizona Liver Health - Tucson — Tucson, Arizona, United States
• Arkansas Diagnostic Center/Liver Wellness Center — Little Rock, Arkansas, United States
• Arkansas Gastroenterology — North Little Rock, Arkansas, United States
• Southern California Research Center — Coronado, California, United States
• University of California, San Francisco-Fresno — Fresno, California, United States
• Univ. of California San Diego School of Medicine — La Jolla, California, United States
• Keck School of Medicine of USC — Los Angeles, California, United States
• Knowledge Research Center — Orange, California, United States
• California Liver Research Institute — Pasadena, California, United States
• University of Colorado — Aurora, Colorado, United States
• South Denver Gastroenterology — Engelwood, Colorado, United States
• Tampa Bay Medical Research — Clearwater, Florida, United States
• Hi Tech and Global Research — Coral Gables, Florida, United States
• Top Medical Research Inc — Cutler Bay, Florida, United States
• Covenant Research - Fort Myers — Fort Myers, Florida, United States
• Nature Coast Clinical Research - Inverness — Inverness, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Ocala GI Research DBA Lake Center for Clinical Research — Lady Lake, Florida, United States
• Florida Research Institute — Lakewood Rch, Florida, United States
• Schiff Center for Liver Diseases/Univ of Miami — Miami, Florida, United States
• Sanchez Clinical Research — Miami, Florida, United States
• University of Alabama at Birmingham (UAB) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.