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Clinical Trials in the USA / NCT05500222
Active, not recruiting Phase 3

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

NCT05500222 · tracked via the Priya Life Science USA tracker
Sponsor
Madrigal Pharmaceuticals, Inc.
Phase
Phase 3
Started
2022-08-26
Last updated
2026-07-08

Condition(s) studied

NASHCirrhosis, Liver

Investigational drug(s) / intervention(s)

ResmetiromPlacebo

Resmetirom: Randomized 80 mg

Placebo: randomized matching placebo

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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) 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 * 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)

Primary outcome measure(s)

Trial sites (141)

FacilityCityRegionStatus
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
Ocala GI Research Ocala Florida
AdventHealth Orlando th Investigational Drug Services Orlando Florida
St Johns Center for Clinical Research Saint Augustine Florida
Covenant Research Sarasota Florida
International Center for Research Tampa Florida
Florida Medical Clinic Zephyrhills Florida
Summit Clinical Research Athens Georgia
Gastrointestinal Specialists of Georgia Marietta Georgia
Northwestern University Chicago Illinois
Rush University Medical Center Chicago Illinois
University of Kansas Medical Center Kansas City Kansas
Kansas Medical Clinic - Gastroenterology Topeka Kansas
Delta Research Partners - Bastrop Bastrop Louisiana
Tandem Clinical Research Marrero Louisiana
Tulane University School of Medicine New Orleans Louisiana

+ 101 more sites — see the full list on the official registry below.

More Madrigal Pharmaceuticals, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05500222 on ClinicalTrials.gov ↗ ← All trials in the USA