New drug aims to stop liver failure in NASH patients

NCT ID NCT05500222

Disease control Sponsor: Madrigal Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jul 09, 2026 · Updated 3 times

Summary

This phase 3 study tests whether a daily pill called resmetirom can prevent serious liver events like liver failure, need for transplant, or bleeding in people with NASH cirrhosis. About 845 adults with well-compensated cirrhosis will receive either the drug or a placebo. The goal is to see if the drug delays or reduces these life-threatening complications.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: resmetirom (a drug taken daily as a pill)
What this could lead to: If it works, this could provide a treatment to delay or prevent serious liver complications like liver failure or need for transplant in people with NASH cirrhosis.
What could go wrong: This is a late-stage trial, but the drug may not reduce complications as hoped. Side effects from the daily medication are possible, and results may not apply to all patients with NASH cirrhosis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 845 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver metabolic dysfunction-associated steatohepatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cirrhosis, liver NASH

Contacts and locations

Locations

Adobe Clinical Research

Tucson, Arizona, 85712, United States
AdventHealth Orlando th Investigational Drug Services

Orlando, Florida, 32804, United States
Algemeen Ziekenhuis Delta

Roeselare, West-Vlaanderen, 8800, Belgium
Algemeen Ziekenhuis Maria Middelares

Ghent, Oost-Vlaanderen, Belgium
Apex Mobile Clinical Research, LLC

Bellaire, Texas, 77401, United States
Arizona Liver Health - Chandler

Chandler, Arizona, 85224, United States
Arizona Liver Health - Peoria

Peoria, Arizona, 85381, United States
Arizona Liver Health - Tucson

Tucson, Arizona, 85712, United States
Arkansas Diagnostic Center/Liver Wellness Center

Little Rock, Arkansas, 72205-6414, United States
Arkansas Gastroenterology

North Little Rock, Arkansas, 72117, United States
Atrium Health CMC Liver Disease Research

Charlotte, North Carolina, 28204, United States
Azienda Ospedaliero - Universitaria Careggi

Florence, Italy
Azienda Ospedaliero-Universitaria Pisana Ospedale Cisanello

Pisa, 56124, Italy
Barts Health NHS Trust

London, England, United Kingdom
Baylor College of Medicine

Houston, Texas, 77030, United States
Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States
Bon Secours Liver Institute of Richmond

Richmond, Virginia, 23226, United States
Boston Medical Center

Boston, Massachusetts, 02118, United States
CHU de LILLE - Hopital Claude Huriez

Lille, Hauts-de-France, 59037, France
CHU de Nice - Hopital de l'Archet 2

Nice, 06202, France
CUB Hôpital Erasme

Brussels, 1070, Belgium
California Liver Research Institute

Pasadena, California, 91105, United States
Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, United Kingdom
Charite - Universitatsmedizin Berlin CVK

Berlin, 13353, Germany
Clinical Research Institute of Ohio

Westlake, Ohio, 44145, United States
Cliniques Universitaires Saint Luc

Brussels, 1200, Belgium
Coastal Research Institute

Fayetteville, North Carolina, 28304, United States
Columbia Digestive Health Research

Columbia, South Carolina, 29204, United States
Covenant Research

Sarasota, Florida, 34240, United States
Covenant Research - Fort Myers

Fort Myers, Florida, 33912, United States
DHR Health Institute for Research & Development

McAllen, Texas, 78504, United States
Dallas VA Medical Center

Dallas, Texas, 75216, United States
Delta Research Partners - Bastrop

Bastrop, Louisiana, 71220, United States
Digestive Health Research of Central Texas

Waco, Texas, 76712, United States
Duke University Medical Center

Durham, North Carolina, 27705, United States
Eugastro Clinical Studies GmbH

Leipzig, Saxony, 04103, Germany
FDI Clinical Research (Fundacion de Investigacion de Diego)

San Juan, Puerto Rico, 00927, Puerto Rico
Florida Medical Clinic

Zephyrhills, Florida, 33542, United States
Florida Research Institute

Lakewood Rch, Florida, 34238, United States
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Milano, Italy
Fondazione Policlinico Universitario Agostino Gemelli

Roma, Roma, Italy
GI Alliance

Fort Worth, Texas, 76104, United States
GI Alliance, Texas Digestive Disease Consultants

Dallas, Texas, 75246, United States
GI Select Health Research

Richmond, Virginia, 23236, United States
Gastro One

Cordova, Tennessee, 38018, United States
Gastrointestinal Specialists of Georgia

Marietta, Georgia, 30060, United States
Harborview Medical Center

Seattle, Washington, 98104, United States
Henry Ford Columbus Center

Novi, Michigan, 48377, United States
Hi Tech and Global Research

Coral Gables, Florida, 33134, United States
Hopital Henri Mondor

Créteil, 94010, France
Hopital Rangueil - CHU Toulouse

Toulouse, 31059, France
Hospital Clinic de Barcelona

Barcelona, 08036, Spain
Hospital General Universitario Gregorio Marañón

Madrid, Spain
Hospital Universitari Vall d'Hebrón

Barcelona, Spain
Hospital Universitario La Paz

Madrid, 28046, Spain
Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, Spain
Hospital Universitario Virgen del Rocío

Seville, 41013, Spain
Houston Methodist Hospital

Houston, Texas, 77030, United States
Houston Research Institute

Houston, Texas, 77079, United States
Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States
Hôpital Beaujon

Clichy, France
Hôpital Brabois Adultes - CHU de Nancy

Vandœuvre-lès-Nancy, Grand Est, 54511, France
Hôpital Universitaire Pitié Salpêtrière

Paris, France
Hôpital de la Croix Rousse

Lyon, Auvergne-Rhône-Alpes, France
IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, 71013, Italy
Impact Research Institute

Waco, Texas, 76710, United States
Imperial College Healthcare NHS Trust

London, England, United Kingdom
International Center for Research

Tampa, Florida, 33614, United States
Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy
Istituto Mediterraneo e della Scienza di Torino

Torino, Turin, 10126, Italy
Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)

Palermo, Italy
Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States
Kansas City Research Institute

Kansas City, Missouri, 64131, United States
Kansas Medical Clinic - Gastroenterology

Topeka, Kansas, 666006, United States
Keck School of Medicine of USC

Los Angeles, California, 90033, United States
King's College Hospital NHS Foundation Trust

London, England, SE5 9RS, United Kingdom
Knowledge Research Center

Orange, California, 92868, United States
Latin Clinical Trials Center

San Juan, Puerto Rico, 00909, Puerto Rico
Liver Center of Texas

Dallas, Texas, 75234, United States
Liver Institute Northwest

Seattle, Washington, 98105, United States
Louisiana Research Center

Shreveport, Louisiana, 71105, United States
Lucas Research

Morehead City, North Carolina, 28557, United States
Mayo Clinic

Rochester, Minnesota, 55905, United States
McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada
Medical University of South Carolina

Charleston, South Carolina, 29425, United States
Mercy Medical Center

Baltimore, Maryland, 21202, United States
Mount Sinai Health System

New York, New York, 10029, United States
NYU Langone Health Gastroenterology and Hepatology Associates

New York, New York, 10016, United States
Nature Coast Clinical Research - Inverness

Inverness, Florida, 34452, United States
Northwestern University

Chicago, Illinois, 60208, United States
Nouvel Hôpital Civil- Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France
Ocala GI Research

Ocala, Florida, 34471, United States
Ocala GI Research DBA Lake Center for Clinical Research

Lady Lake, Florida, 32159, United States
Pinnacle Clinical Research - Austin

Austin, Texas, 78757, United States
Pinnacle Clinical Research - Georgetown

Georgetown, Texas, 78626, United States
Pinnacle Clinical Research - San Antonio

San Antonio, Texas, 78229, United States
Premier Health Research

Sparta, New Jersey, 07871, United States
Premier Medical Group

Clarksville, Tennessee, 37040, United States
Quality Medical Reseach, PLLC

Nashville, Tennessee, 37211, United States
Rapid City Medical Center

Rapid City, South Dakota, 57701, United States
Regional Gastroenterology Associates of Lancaster

Flourtown, Pennsylvania, 19031, United States
Royal Free London NHS Foundation Trust

London, England, United Kingdom
Rush University Medical Center

Chicago, Illinois, 60612, United States
Saint Louis University

St Louis, Missouri, 63104, United States
Sanchez Clinical Research

Miami, Florida, 33157, United States
Schiff Center for Liver Diseases/Univ of Miami

Miami, Florida, 33136, United States
South Denver Gastroenterology

Engelwood, Colorado, 80113, United States
South Texas Research Institute - Brownsville

Brownsville, Texas, 78520, United States
South Texas Research Institute - Edinburg

Edinburg, Texas, 78539, United States
Southern California Research Center

Coronado, California, 92118, United States
St Johns Center for Clinical Research

Saint Augustine, Florida, 32086, United States
Summit Clinical Research

Athens, Georgia, 30607, United States
Tampa Bay Medical Research

Clearwater, Florida, 33761, United States
Tandem Clinical Research

Marrero, Louisiana, 70072, United States
Texas Clinical Research Institute

Arlington, Texas, 76012-3216, United States
The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, 75203, United States
The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States
Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States
Top Medical Research Inc

Cutler Bay, Florida, 33189, United States
Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada
Toronto Liver Center

Toronto, Ontario, M6H 3M1, Canada
Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States
UPMC - Center for Liver Diseases

Pittsburgh, Pennsylvania, 15213, United States
Umass Chan Medical School

Worcester, Massachusetts, 01655, United States
Univ. of California San Diego School of Medicine

La Jolla, California, 92037, United States
Universitair Ziekenhuis Gent

Ghent, Oost-Vlaanderen, Belgium
University Hospital of Leipzig

Leipzig, Hesse, 04103, Germany
University Hospitals Birmingham NHS Foundation Trust

Birmingham, England, United Kingdom
University of Alabama at Birmingham (UAB)

Birmingham, Alabama, 35249, United States
University of Calgary Liver Unit

Calgary, Alberta, Canada
University of California, San Francisco-Fresno

Fresno, California, 93701, United States
University of Colorado

Aurora, Colorado, 80045, United States
University of Kansas Medical Center

Kansas City, Kansas, 66160, United States
University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States
University of Vermont Medical Center

Burlington, Vermont, 05401, United States
University of Virginia Health System

Charlottesville, Virginia, 22903, United States
Universitätsmedizin Mainz

Mainz, Rhineland-Palatinate, 55131, Germany
Velocity Clinical Research - Providence

East Greenwich, Rhode Island, 02818, United States
Virginia Commonwealth University School of Medicine

Richmond, Virginia, 23298, United States
Weill Cornell Medical College

New York, New York, 10021, United States
William Osler Health System - Brampton Civic Hospital

Brampton, Ontario, L6R 3J7, Canada

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