Who is eligible for clinical trial NCT05500222?

Participants must meet the protocol's inclusion criteria for NASH. The stated age range is 18 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT05500222 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-06

A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES) (NCT05500222)

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)

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Madrigal Pharmaceuticals, Inc.

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (14 items).

Location: University of Alabama at Birmingham (UAB) — Birmingham, Alabama

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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)

Usually NOT eligible if any of the following apply:

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
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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (141 Sites)

Showing the first 25 of 141 sites.

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

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in NASH

Digoxin In NASH (CODIN) — New Haven, Connecticut
Optimizing Noninvasive assessMent Of DysmEtabolic Compensated Advanced Liver Disease — Roma, Roma

Explore by condition: All NASH clinical trials

💡 How to Participate

Check the checklist above to see if you may qualify.
Review the official NIH record below to find the coordinating site.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗