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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 Oct 16, 2026, 10:48 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 26, 2022 (Actual)
Primary completion
Dec 2026 (Estimated)
Completion
Jan 2027 (Estimated)
Last update posted
Jul 8, 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.

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 8, 2026 · Synced Oct 16, 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 public registry record, listed eligibility criteria, and available contact information for NCT05500222 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →