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Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05500222

Public ClinicalTrials.gov record NCT05500222. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Aug 2, 2026, 10:18 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05500222
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Madrigal Pharmaceuticals, Inc.
Industry
Enrollment
845 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 25, 2022
Primary completion
Nov 30, 2026
Completion
Dec 31, 2026
Last update posted
Jul 7, 2026

2022 – 2027

United States locations

U.S. sites
96
U.S. states
28
U.S. cities
79
Facility City State ZIP Site status
University of Alabama at Birmingham (UAB) Birmingham Alabama 35249
Arizona Liver Health - Chandler Chandler Arizona 85224
Arizona Liver Health - Peoria Peoria Arizona 85381
Adobe Clinical Research Tucson Arizona 85712
Arizona Liver Health - Tucson Tucson Arizona 85712
Arkansas Diagnostic Center/Liver Wellness Center Little Rock Arkansas 72205-6414
Arkansas Gastroenterology North Little Rock Arkansas 72117
Southern California Research Center Coronado California 92118
University of California, San Francisco-Fresno Fresno California 93701
Univ. of California San Diego School of Medicine La Jolla California 92037
Keck School of Medicine of USC Los Angeles California 90033
Knowledge Research Center Orange California 92868
California Liver Research Institute Pasadena California 91105
University of Colorado Aurora Colorado 80045
South Denver Gastroenterology Engelwood Colorado 80113
Tampa Bay Medical Research Clearwater Florida 33761
Hi Tech and Global Research Coral Gables Florida 33134
Top Medical Research Inc Cutler Bay Florida 33189
Covenant Research - Fort Myers Fort Myers Florida 33912
Nature Coast Clinical Research - Inverness Inverness Florida 34452
Jacksonville Center for Clinical Research Jacksonville Florida 32216
Ocala GI Research DBA Lake Center for Clinical Research Lady Lake Florida 32159
Florida Research Institute Lakewood Rch Florida 34238
Schiff Center for Liver Diseases/Univ of Miami Miami Florida 33136
Sanchez Clinical Research Miami Florida 33157
Ocala GI Research Ocala Florida 34471
AdventHealth Orlando th Investigational Drug Services Orlando Florida 32804
St Johns Center for Clinical Research Saint Augustine Florida 32086
Covenant Research Sarasota Florida 34240
International Center for Research Tampa Florida 33614
Florida Medical Clinic Zephyrhills Florida 33542
Summit Clinical Research Athens Georgia 30607
Gastrointestinal Specialists of Georgia Marietta Georgia 30060
Northwestern University Chicago Illinois 60208
Rush University Medical Center Chicago Illinois 60612
University of Kansas Medical Center Kansas City Kansas 66160
Kansas Medical Clinic - Gastroenterology Topeka Kansas 666006
Delta Research Partners - Bastrop Bastrop Louisiana 71220
Tandem Clinical Research Marrero Louisiana 70072
Tulane University School of Medicine New Orleans Louisiana 70112
Louisiana Research Center Shreveport Louisiana 71105
Mercy Medical Center Baltimore Maryland 21202
Boston Medical Center Boston Massachusetts 02118
Beth Israel Deaconess Medical Center Boston Massachusetts 02215
Umass Chan Medical School Worcester Massachusetts 01655
Henry Ford Columbus Center Novi Michigan 48377
Mayo Clinic Rochester Minnesota 55905
Kansas City Research Institute Kansas City Missouri 64131
Saint Louis University St Louis Missouri 63104
Premier Health Research Sparta New Jersey 07871
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
Atrium Health CMC Liver Disease Research Charlotte North Carolina 28204
Duke University Medical Center Durham North Carolina 27705
Coastal Research Institute Fayetteville North Carolina 28304
Lucas Research Morehead City North Carolina 28557
The Ohio State University Wexner Medical Center Columbus Ohio 43210
Clinical Research Institute of Ohio Westlake Ohio 44145
Regional Gastroenterology Associates of Lancaster Flourtown Pennsylvania 19031
Thomas Jefferson University Philadelphia Pennsylvania 19107
UPMC - Center for Liver Diseases Pittsburgh Pennsylvania 15213
Velocity Clinical Research - Providence East Greenwich Rhode Island 02818
Medical University of South Carolina Charleston South Carolina 29425
Columbia Digestive Health Research Columbia South Carolina 29204
Rapid City Medical Center Rapid City South Dakota 57701
Premier Medical Group Clarksville Tennessee 37040
Gastro One Cordova Tennessee 38018
Quality Medical Reseach, PLLC Nashville Tennessee 37211
Texas Clinical Research Institute Arlington Texas 76012-3216
Pinnacle Clinical Research - Austin Austin Texas 78757
Apex Mobile Clinical Research, LLC Bellaire Texas 77401
South Texas Research Institute - Brownsville Brownsville Texas 78520
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
South Texas Research Institute - Edinburg Edinburg Texas 78539
GI Alliance Fort Worth Texas 76104
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
DHR Health Institute for Research & Development McAllen Texas 78504
Pinnacle Clinical Research - San Antonio San Antonio Texas 78229
Impact Research Institute Waco Texas 76710
Digestive Health Research of Central Texas Waco Texas 76712
University of Vermont Medical Center Burlington Vermont 05401
University of Virginia Health System Charlottesville Virginia 22903
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
Harborview Medical Center Seattle Washington 98104
Liver Institute Northwest Seattle Washington 98105

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 45 non-U.S. sites.

Recently updated Cirrhosis, Liver trials

Other public records listing Cirrhosis, Liver. Sorted by last update posted; newest first. Not a recommendation.

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About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05500222, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 7, 2026 · Synced Aug 2, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05500222 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →