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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

700

Start Date

2022-08-26

Completion Date

2027-01

Last Updated

2025-06-11

Healthy Volunteers

Conditions

NASH Cirrhosis, Liver

Interventions

DRUG

Resmetirom

Randomized 80 mg

DRUG

Placebo

randomized matching placebo

Inclusion Criteria: * Definitive (by histologic documentation) or probable NASH as causative agent for cirrhosis, following a modified version of the NASH Cirrhosis: Liver Forum Consensus Definitions for Clinical Trials. * a. Most recent biopsy (within last 5 years) shows cirrhosis with a NAS of ≥ 2, and at least two components: one being steatosis and at least one other component; OR NAS of ≥ 2, if steatosis = 0 or is ungraded with inflammation and/or ballooning, eligible with an MRI-PDFF \>5%. If steatosis and ballooning and/or steatosis and inflammation are noted by the local pathologist, then the biopsy qualifies even if a NAS is not provided (Approximately 70% of the study patient population) b. Historical biopsy (within last 5 years) showed NASH with significant fibrosis with pathology report documenting "F2" or "F3", with at least steatosis either by biopsy with no minimal percentage required or by MRI-PDFF \>5%, AND inflammation or ballooning. Now with cirrhosis, either by clinical history or current features, imaging, noninvasive tests, or biopsy (see Appendix 7) (Up to approximately 20% of study patient population) c. Historical biopsy (within last 5 years) shows steatosis. Pathology report documents steatosis with no minimal percentage required. Now with cirrhosis, either by clinical history or current features, imaging, noninvasive tests, or biopsy (see Appendix 7). Prescreening metabolic risk factors must include obesity and/or T2D. (Up to approximately 10% of study patient population.) * Well-compensated NASH cirrhosis at screening and baseline with Child-Pugh A (score of 5-6) (no history of hepatic decompensation event). * At least 3 metabolic risk factors * Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) that is obtained during the Screening period or a historic MRI-PDFF at ≤8 weeks old at the time of randomization with no weight change ≥5% weight change in that interval. * MRE ≥4.2 where MRE is available. * Enhanced liver function (ELF) ≥9.8, only if MRE is unavailable or contraindicated. Exclusion Criteria: * 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, are excluded. * Participants with MELD score ≥12 due to liver disease are excluded. * Participants with a history of hepatic decompensation or impairment are excluded.

Locations (55)

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

California Liver Research Institute

Pasadena, California, United States

South Denver Gastroenterology

Englewood, Colorado, 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

Sanchez Clinical Research

Miami, Florida, United States

Ocala GI Research

Ocala, 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

Kansas Medical Clinic - Gastroenterology

Topeka, Kansas, United States

Delta Research Partners - Bastrop

Bastrop, Louisiana, United States

Louisiana Research Center

Shreveport, Louisiana, United States

Mercy Medical Center

Baltimore, Maryland, United States

Kansas City Research Institute

Kansas City, Missouri, United States

Premier Health Research

Sparta, New Jersey, United States

Lucas Research

Morehead City, North Carolina, United States

Regional Gastroenterology Associates of Lancaster

Flourtown, Pennsylvania, 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

Texas Clinical Research Institute

Arlington, Texas, United States

Pinnacle Clinical Research - Austin

Austin, Texas, United States

South Texas Research Institute - Brownsville

Brownsville, Texas, United States

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, United States

Liver Center of Texas

Dallas, Texas, United States

South Texas Research Institute - Edinburg

Edinburg, Texas, United States

Pinnacle Clinical Research - Georgetown

Georgetown, Texas, United States

Houston Research Institute

Houston, 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

GI Select Health Research

Richmond, Virginia, United States

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States

Liver Institute Northwest

Seattle, Washington, United States

Latin Clinical Trials Center

San Juan, Puerto Rico

FDI Clinical Research (Fundacion de Investigacion de Diego)