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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.
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
Conditions
Interventions
Resmetirom
Randomized 80 mg
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