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ACTIVE NOT RECRUITING
NCT05500222
PHASE3

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

Sponsor: Madrigal Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

845

Start Date

2022-08-26

Completion Date

2027-01

Last Updated

2026-07-08

Healthy Volunteers

No

Interventions

DRUG

Resmetirom

Randomized 80 mg

DRUG

Placebo

randomized matching placebo

Locations (141)

University of Alabama at Birmingham (UAB)

Birmingham, Alabama, United States

Arizona Liver Health - Chandler

Chandler, Arizona, United States

Arizona Liver Health - Peoria

Peoria, Arizona, United States

Adobe Clinical Research

Tucson, Arizona, United States

Arizona Liver Health - Tucson

Tucson, Arizona, United States

Arkansas Diagnostic Center/Liver Wellness Center

Little Rock, Arkansas, United States

Arkansas Gastroenterology

North Little Rock, Arkansas, United States

Southern California Research Center

Coronado, California, United States

University of California, San Francisco-Fresno

Fresno, California, United States

Univ. of California San Diego School of Medicine

La Jolla, California, United States

Keck School of Medicine of USC

Los Angeles, California, United States

Knowledge Research Center

Orange, California, United States

California Liver Research Institute

Pasadena, California, United States

University of Colorado

Aurora, Colorado, United States

South Denver Gastroenterology

Engelwood, Colorado, United States

Tampa Bay Medical Research

Clearwater, Florida, United States

Hi Tech and Global Research

Coral Gables, Florida, United States

Top Medical Research Inc

Cutler Bay, Florida, United States

Covenant Research - Fort Myers

Fort Myers, Florida, United States

Nature Coast Clinical Research - Inverness

Inverness, Florida, United States

Jacksonville Center for Clinical Research

Jacksonville, Florida, United States

Ocala GI Research DBA Lake Center for Clinical Research

Lady Lake, Florida, United States

Florida Research Institute

Lakewood Rch, Florida, United States

Schiff Center for Liver Diseases/Univ of Miami

Miami, Florida, United States

Sanchez Clinical Research

Miami, Florida, United States

Ocala GI Research

Ocala, Florida, United States

AdventHealth Orlando th Investigational Drug Services

Orlando, Florida, United States

St Johns Center for Clinical Research

Saint Augustine, Florida, United States

Covenant Research

Sarasota, Florida, United States

International Center for Research

Tampa, Florida, United States

Florida Medical Clinic

Zephyrhills, Florida, United States

Summit Clinical Research

Athens, Georgia, United States

Gastrointestinal Specialists of Georgia

Marietta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Kansas Medical Clinic - Gastroenterology

Topeka, Kansas, United States

Delta Research Partners - Bastrop

Bastrop, Louisiana, United States

Tandem Clinical Research

Marrero, Louisiana, United States

Tulane University School of Medicine

New Orleans, Louisiana, United States

Louisiana Research Center

Shreveport, Louisiana, United States

Mercy Medical Center

Baltimore, Maryland, United States

Boston Medical Center

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Umass Chan Medical School

Worcester, Massachusetts, United States

Henry Ford Columbus Center

Novi, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Kansas City Research Institute

Kansas City, Missouri, United States

Saint Louis University

St Louis, Missouri, United States

Premier Health Research

Sparta, New Jersey, United States

NYU Langone Health Gastroenterology and Hepatology Associates

New York, New York, United States

Weill Cornell Medical College

New York, New York, United States

Mount Sinai Health System

New York, New York, United States

Atrium Health CMC Liver Disease Research

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Coastal Research Institute

Fayetteville, North Carolina, United States

Lucas Research

Morehead City, North Carolina, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Clinical Research Institute of Ohio

Westlake, Ohio, United States

Regional Gastroenterology Associates of Lancaster

Flourtown, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

UPMC - Center for Liver Diseases

Pittsburgh, Pennsylvania, United States

Velocity Clinical Research - Providence

East Greenwich, Rhode Island, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Columbia Digestive Health Research

Columbia, South Carolina, United States

Rapid City Medical Center

Rapid City, South Dakota, United States

Premier Medical Group

Clarksville, Tennessee, United States

Gastro One

Cordova, Tennessee, United States

Quality Medical Reseach, PLLC

Nashville, Tennessee, United States

Texas Clinical Research Institute

Arlington, Texas, United States

Pinnacle Clinical Research - Austin

Austin, Texas, United States

Apex Mobile Clinical Research, LLC

Bellaire, Texas, United States

South Texas Research Institute - Brownsville

Brownsville, Texas, United States

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, United States

Dallas VA Medical Center

Dallas, Texas, United States

Liver Center of Texas

Dallas, Texas, United States

GI Alliance, Texas Digestive Disease Consultants

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

South Texas Research Institute - Edinburg

Edinburg, Texas, United States

GI Alliance

Fort Worth, Texas, United States

Pinnacle Clinical Research - Georgetown

Georgetown, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Houston Research Institute

Houston, Texas, United States

DHR Health Institute for Research & Development

McAllen, Texas, United States

Pinnacle Clinical Research - San Antonio

San Antonio, Texas, United States

Impact Research Institute

Waco, Texas, United States

Digestive Health Research of Central Texas

Waco, Texas, United States

University of Vermont Medical Center

Burlington, Vermont, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Bon Secours Liver Institute of Richmond

Richmond, Virginia, United States

GI Select Health Research

Richmond, Virginia, United States

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States

Virginia Commonwealth University School of Medicine

Richmond, Virginia, United States

Harborview Medical Center

Seattle, Washington, United States

Liver Institute Northwest

Seattle, Washington, United States

Algemeen Ziekenhuis Maria Middelares

Ghent, Oost-Vlaanderen, Belgium

Universitair Ziekenhuis Gent

Ghent, Oost-Vlaanderen, Belgium

Algemeen Ziekenhuis Delta

Roeselare, West-Vlaanderen, Belgium

CUB Hôpital Erasme

Brussels, Belgium

Cliniques Universitaires Saint Luc

Brussels, Belgium

University of Calgary Liver Unit

Calgary, Alberta, Canada

William Osler Health System - Brampton Civic Hospital

Brampton, Ontario, Canada

Toronto General Hospital

Toronto, Ontario, Canada

Toronto Liver Center

Toronto, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada

Hôpital de la Croix Rousse

Lyon, Auvergne-Rhône-Alpes, France

Hôpital Brabois Adultes - CHU de Nancy

Vandœuvre-lès-Nancy, Grand Est, France

CHU de LILLE - Hopital Claude Huriez

Lille, Hauts-de-France, France

Hôpital Beaujon

Clichy, France

Hopital Henri Mondor

Créteil, France

CHU de Nice - Hopital de l'Archet 2

Nice, France

Hôpital Universitaire Pitié Salpêtrière

Paris, France

Nouvel Hôpital Civil- Hôpitaux Universitaires de Strasbourg

Strasbourg, France

Hopital Rangueil - CHU Toulouse

Toulouse, France

University Hospital of Leipzig

Leipzig, Hesse, Germany

Universitätsmedizin Mainz

Mainz, Rhineland-Palatinate, Germany

Eugastro Clinical Studies GmbH

Leipzig, Saxony, Germany

Charite - Universitatsmedizin Berlin CVK

Berlin, Germany

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Milano, Italy

Istituto Clinico Humanitas

Rozzano, Milan, Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, Roma, Italy

Istituto Mediterraneo e della Scienza di Torino

Torino, Turin, Italy

Azienda Ospedaliero - Universitaria Careggi

Florence, Italy

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

Palermo, Italy

Azienda Ospedaliero-Universitaria Pisana Ospedale Cisanello

Pisa, Italy

Latin Clinical Trials Center

San Juan, Puerto Rico, Puerto Rico

FDI Clinical Research (Fundacion de Investigacion de Diego)

San Juan, Puerto Rico, Puerto Rico

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Universitari Vall d'Hebrón

Barcelona, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

University Hospitals Birmingham NHS Foundation Trust

Birmingham, England, United Kingdom

Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, United Kingdom

King's College Hospital NHS Foundation Trust

London, England, United Kingdom

Barts Health NHS Trust

London, England, United Kingdom

Imperial College Healthcare NHS Trust

London, England, United Kingdom

Royal Free London NHS Foundation Trust

London, England, United Kingdom