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NASHPhase 3NCT05500222

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

A Phase 3 study testing Resmetirom in people with NASH and Cirrhosis, Liver, run by Madrigal Pharmaceuticals, Inc. at 141 sites in 9 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
NASH, Cirrhosis, Liver
What is being tested?
Resmetirom
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
845 participants
Where
141 sitesin 9 countries
Study dates
26 Aug 2022to Jan 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 13Show fewer
  • 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)

Trial locations and contacts

141 sites in 9 countries.

141 sites in 9 countries

United States96 sites

  • Texas Clinical Research Institute

    Arlington, Texas, 76012-3216

  • Summit Clinical Research

    Athens, Georgia, 30607

  • University of Colorado

    Aurora, Colorado, 80045

  • Pinnacle Clinical Research - Austin

    Austin, Texas, 78757

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Delta Research Partners - Bastrop

    Bastrop, Louisiana, 71220

  • Apex Mobile Clinical Research, LLC

    Bellaire, Texas, 77401

  • University of Alabama at Birmingham (UAB)

    Birmingham, Alabama, 35249

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • South Texas Research Institute - Brownsville

    Brownsville, Texas, 78520

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Arizona Liver Health - Chandler

    Chandler, Arizona, 85224

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Atrium Health CMC Liver Disease Research

    Charlotte, North Carolina, 28204

  • University of Virginia Health System

    Charlottesville, Virginia, 22903

  • Northwestern University

    Chicago, Illinois, 60208

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Premier Medical Group

    Clarksville, Tennessee, 37040

  • Tampa Bay Medical Research

    Clearwater, Florida, 33761

  • Columbia Digestive Health Research

    Columbia, South Carolina, 29204

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • Hi Tech and Global Research

    Coral Gables, Florida, 33134

  • Gastro One

    Cordova, Tennessee, 38018

  • Southern California Research Center

    Coronado, California, 92118

  • Top Medical Research Inc

    Cutler Bay, Florida, 33189

  • The Liver Institute at Methodist Dallas Medical Center

    Dallas, Texas, 75203

  • Dallas VA Medical Center

    Dallas, Texas, 75216

  • Liver Center of Texas

    Dallas, Texas, 75234

  • GI Alliance, Texas Digestive Disease Consultants

    Dallas, Texas, 75246

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Duke University Medical Center

    Durham, North Carolina, 27705

  • Velocity Clinical Research - Providence

    East Greenwich, Rhode Island, 02818

  • South Texas Research Institute - Edinburg

    Edinburg, Texas, 78539

  • South Denver Gastroenterology

    Engelwood, Colorado, 80113

  • Coastal Research Institute

    Fayetteville, North Carolina, 28304

  • Regional Gastroenterology Associates of Lancaster

    Flourtown, Pennsylvania, 19031

  • Covenant Research - Fort Myers

    Fort Myers, Florida, 33912

  • GI Alliance

    Fort Worth, Texas, 76104

  • University of California, San Francisco-Fresno

    Fresno, California, 93701

  • Pinnacle Clinical Research - Georgetown

    Georgetown, Texas, 78626

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Houston Research Institute

    Houston, Texas, 77079

  • Nature Coast Clinical Research - Inverness

    Inverness, Florida, 34452

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Kansas City Research Institute

    Kansas City, Missouri, 64131

  • Univ. of California San Diego School of Medicine

    La Jolla, California, 92037

  • Ocala GI Research DBA Lake Center for Clinical Research

    Lady Lake, Florida, 32159

  • Florida Research Institute

    Lakewood Rch, Florida, 34238

  • Arkansas Diagnostic Center/Liver Wellness Center

    Little Rock, Arkansas, 72205-6414

  • Keck School of Medicine of USC

    Los Angeles, California, 90033

  • Gastrointestinal Specialists of Georgia

    Marietta, Georgia, 30060

  • Tandem Clinical Research

    Marrero, Louisiana, 70072

  • DHR Health Institute for Research & Development

    McAllen, Texas, 78504

  • Schiff Center for Liver Diseases/Univ of Miami

    Miami, Florida, 33136

  • Sanchez Clinical Research

    Miami, Florida, 33157

  • Lucas Research

    Morehead City, North Carolina, 28557

  • Quality Medical Reseach, PLLC

    Nashville, Tennessee, 37211

  • Tulane University School of Medicine

    New Orleans, Louisiana, 70112

  • NYU Langone Health Gastroenterology and Hepatology Associates

    New York, New York, 10016

  • Weill Cornell Medical College

    New York, New York, 10021

  • Mount Sinai Health System

    New York, New York, 10029

  • Arkansas Gastroenterology

    North Little Rock, Arkansas, 72117

  • Henry Ford Columbus Center

    Novi, Michigan, 48377

  • Ocala GI Research

    Ocala, Florida, 34471

  • Knowledge Research Center

    Orange, California, 92868

  • AdventHealth Orlando th Investigational Drug Services

    Orlando, Florida, 32804

  • California Liver Research Institute

    Pasadena, California, 91105

  • Arizona Liver Health - Peoria

    Peoria, Arizona, 85381

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • UPMC - Center for Liver Diseases

    Pittsburgh, Pennsylvania, 15213

  • Rapid City Medical Center

    Rapid City, South Dakota, 57701

  • Bon Secours Liver Institute of Richmond

    Richmond, Virginia, 23226

  • GI Select Health Research

    Richmond, Virginia, 23236

  • Hunter Holmes McGuire VA Medical Center

    Richmond, Virginia, 23249

  • Virginia Commonwealth University School of Medicine

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • St Johns Center for Clinical Research

    Saint Augustine, Florida, 32086

  • Pinnacle Clinical Research - San Antonio

    San Antonio, Texas, 78229

  • Covenant Research

    Sarasota, Florida, 34240

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Liver Institute Northwest

    Seattle, Washington, 98105

  • Louisiana Research Center

    Shreveport, Louisiana, 71105

  • Premier Health Research

    Sparta, New Jersey, 07871

  • Saint Louis University

    St Louis, Missouri, 63104

  • International Center for Research

    Tampa, Florida, 33614

  • Kansas Medical Clinic - Gastroenterology

    Topeka, Kansas, 666006

  • Adobe Clinical Research

    Tucson, Arizona, 85712

  • Arizona Liver Health - Tucson

    Tucson, Arizona, 85712

  • Impact Research Institute

    Waco, Texas, 76710

  • Digestive Health Research of Central Texas

    Waco, Texas, 76712

  • Clinical Research Institute of Ohio

    Westlake, Ohio, 44145

  • Umass Chan Medical School

    Worcester, Massachusetts, 01655

  • Florida Medical Clinic

    Zephyrhills, Florida, 33542

Other trials in United States

France9 sites

  • Hôpital Beaujon

    Clichy

  • Hopital Henri Mondor

    Créteil, 94010

  • CHU de LILLE - Hopital Claude Huriez

    Lille, Hauts-de-France, 59037

  • Hôpital de la Croix Rousse

    Lyon, Auvergne-Rhône-Alpes

  • CHU de Nice - Hopital de l'Archet 2

    Nice, 06202

  • Hôpital Universitaire Pitié Salpêtrière

    Paris

  • Nouvel Hôpital Civil- Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091

  • Hopital Rangueil - CHU Toulouse

    Toulouse, 31059

  • Hôpital Brabois Adultes - CHU de Nancy

    Vandœuvre-lès-Nancy, Grand Est, 54511

Other trials in France

Italy8 sites

  • Azienda Ospedaliero - Universitaria Careggi

    Florence

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, Milano

  • Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)

    Palermo

  • Azienda Ospedaliero-Universitaria Pisana Ospedale Cisanello

    Pisa, 56124

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, Roma

  • Istituto Clinico Humanitas

    Rozzano, Milan, 20089

  • IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo, Foggia, 71013

  • Istituto Mediterraneo e della Scienza di Torino

    Torino, Turin, 10126

Other trials in Italy

Spain6 sites

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital Universitari Vall d'Hebrón

    Barcelona

  • Hospital Universitario La Paz

    Madrid, 28046

  • Hospital General Universitario Gregorio Marañón

    Madrid

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

Other trials in Spain

United Kingdom6 sites

  • University Hospitals Birmingham NHS Foundation Trust

    Birmingham, England

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, England

  • King's College Hospital NHS Foundation Trust

    London, England, SE5 9RS

  • Barts Health NHS Trust

    London, England

  • Imperial College Healthcare NHS Trust

    London, England

  • Royal Free London NHS Foundation Trust

    London, England

Other trials in United Kingdom

Belgium5 sites

  • CUB Hôpital Erasme

    Brussels, 1070

  • Cliniques Universitaires Saint Luc

    Brussels, 1200

  • Algemeen Ziekenhuis Maria Middelares

    Ghent, Oost-Vlaanderen

  • Universitair Ziekenhuis Gent

    Ghent, Oost-Vlaanderen

  • Algemeen Ziekenhuis Delta

    Roeselare, West-Vlaanderen, 8800

Other trials in Belgium

Canada5 sites

  • William Osler Health System - Brampton Civic Hospital

    Brampton, Ontario, L6R 3J7

  • University of Calgary Liver Unit

    Calgary, Alberta

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

  • Toronto Liver Center

    Toronto, Ontario, M6H 3M1

Other trials in Canada

Germany4 sites

  • Charite - Universitatsmedizin Berlin CVK

    Berlin, 13353

  • University Hospital of Leipzig

    Leipzig, Hesse, 04103

  • Eugastro Clinical Studies GmbH

    Leipzig, Saxony, 04103

  • Universitätsmedizin Mainz

    Mainz, Rhineland-Palatinate, 55131

Other trials in Germany

Puerto Rico2 sites

  • Latin Clinical Trials Center

    San Juan, Puerto Rico, 00909

  • FDI Clinical Research (Fundacion de Investigacion de Diego)

    San Juan, Puerto Rico, 00927

Other trials in Puerto Rico

About this study

Official title: 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)

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.

Read the detailed description

This is a multi-national, multicenter, double-blind, randomized, placebo-controlled study in participants with well-compensated NASH cirrhosis. Participants will be randomized 3:1 in a blinded manner to receive 80 mg resmetirom or matching placebo given orally once daily in the morning for the duration of the study (until the required number of Composite Clinical Outcome events are achieved). Composite Clinical Outcome events are defined as any of the following: all cause mortality, liver transplant, and significant hepatic events, including potential hepatic decompensation events (ascites, hepatic encephalopathy, or gastroesophageal variceal hemorrhage), and confirmed increase of Model for End-stage Liver Disease (MELD) score from <12 to ≥15. The study comprises an up to 60-day screening period and an approximately 3-year treatment period.

Being tested
Resmetirom, Placebo
Medical subject headings
Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ResmetiromDrug

    Also called MGL-3196

    Randomized 80 mg

  • PlaceboDrug

    randomized matching placebo

Study groups in NCT05500222
Study groupRoleWhat they receive
ResmetiromActive comparator80 mg daily
Receives: Drug: Resmetirom
PlaceboPlacebo comparatormatching placebo daily
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence Of adjudicated Composite Clinical Outcome event

    Any event of all-cause mortality, liver transplant, ascites, hepatic encephalopathy, gastroesophageal variceal hemorrhage, and confirmed increase of MELD score from <12 to >/= 15 due to liver disease

    Measured: Baseline up to Month 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2022
  2. Study start26 Aug 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
845 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05500222
Sponsor's protocol ID
MGL-3196-19
Status last verified
Jul 2026
First submitted
11 Aug 2022
Last updated
8 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Harrison SA, Ratziu V, Anstee QM, Noureddin M, Sanyal AJ, Schattenberg JM, Bedossa P, Bashir MR, Schneider D, Taub R, Bansal M, Kowdley KV, Younossi ZM, Loomba R. Design of the phase 3 MAESTRO clinical program to evaluate resmetirom for the treatment of nonalcoholic steatohepatitis. Aliment Pharmacol Ther. 2024 Jan;59(1):51-63. doi: 10.1111/apt.17734. Epub 2023 Oct 2.

    PubMed 37786277

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Resmetirom in people with NASH and Cirrhosis, Liver, run by Madrigal Pharmaceuticals, Inc. at 141 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 141 sites in United States, France, Italy, Spain, United Kingdom and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence Of adjudicated Composite Clinical Outcome event (time frame: Baseline up to Month 36). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05500222, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.

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