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ACTIVE NOT RECRUITING
NCT03900429
PHASE3

A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis

Sponsor: Madrigal Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

A double-blind placebo controlled randomized Phase 3 study to determine if 80 or 100 mg of MGL-3196 as compared with placebo resolves NASH and/or reduces fibrosis on liver biopsy and prevents progression to cirrhosis and/or advanced liver disease

Official title: A Phase 3, Multinational, Double-Blind, Randomized, Placebo-Controlled Study of MGL-3196 (Resmetirom) in Patients With Non-Alcoholic Steatohepatitis (NASH) and Fibrosis to Resolve NASH and Reduce Progression to Cirrhosis and/or Hepatic Decompensation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1759

Start Date

2019-03-28

Completion Date

2028-01

Last Updated

2026-06-01

Healthy Volunteers

No

Interventions

DRUG

MGL-3196

Tablet

DRUG

Placebo

Matching Tablets

PROCEDURE

Liver Biopsy

A procedure in which a needle is inserted into the liver to collect a tissue sample

Locations (247)

University of Alabama at Birmingham

Birmingham, Alabama, United States

East Valley Family Physicians

Chandler, Arizona, United States

The Institute for Liver Health - Chandler

Chandler, Arizona, United States

The Institute for Liver Health - Glendale

Glendale, Arizona, United States

Desert Clinical Research

Mesa, Arizona, United States

Adobe Gastroenterology

Tucson, Arizona, United States

The Institute for Liver Health - Tucson

Tucson, Arizona, United States

Arkansas Gastroenterology

North Little Rock, Arkansas, United States

Fresno Clinical Research Center

Fresno, California, United States

National Research Institute - Huntington Park

Huntington Park, California, United States

University of California San Diego

La Jolla, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

National Research Institute - Los Angeles

Los Angeles, California, United States

Ruane Clinical Research

Los Angeles, California, United States

Stanford University School of Medicine

Palo Alto, California, United States

National Research Institute - Panorama City

Panorama City, California, United States

Alliance Clinical Research

Poway, California, United States

San Fernando Valley Health Institute

Van Nuys, California, United States

Colorado Springs Family Practice

Colorado Springs, Colorado, United States

South Denver Gastroenterology - Swedish Medical Center Office

Englewood, Colorado, United States

Excel Medical Clinical Trials

Boca Raton, Florida, United States

Covenant Metabolic Specialists - Fort Myers

Fort Myers, Florida, United States

University of Florida Hepatology Research at CTRB

Gainesville, Florida, United States

Nature Coast Clinical Research

Inverness, Florida, United States

Florida Research Institute

Lakewood Rch, Florida, United States

University of Miami

Miami, Florida, United States

Miami Dade Medical Research Institute

Miami, Florida, United States

Bioclinica Research - Orlando

Orlando, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

Covenant Research

Sarasota, Florida, United States

Bioclinica Research - The Villages

The Villages, Florida, United States

GI Specialists of Georgia

Marietta, Georgia, United States

Clinical Research - Chicago

Chicago, Illinois, United States

Northwestern Medical Faculty Foundation

Chicago, Illinois, United States

The University of Chicago Medicine

Chicago, Illinois, United States

University of Kansas Medical Center Research Institute

Fairway, Kansas, United States

Kansas Medical Clinic - Gastroenterology

Topeka, Kansas, United States

Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge

Baton Rouge, Louisiana, United States

Tandem Clinical Research

Marrero, Louisiana, United States

Tulane University School of Medicine

New Orleans, Louisiana, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Clinical Trials of America

West Monroe, Louisiana, United States

Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Gastrointestinal Associates and Endoscopy Center - Madison

Flowood, Mississippi, United States

Southern Therapy and Advanced Research

Jackson, Mississippi, United States

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

St. Luke's Hospital Of Kansas City

Kansas City, Missouri, United States

Kansas City Research Institute

Kansas City, Missouri, United States

Saint Louis University

St Louis, Missouri, United States

Clinical Research US - Henderson

Henderson, Nevada, United States

Mt. Sinai Medical Center

New York, New York, United States

New York Presbyterian Hospital

New York, New York, United States

University of North Carolina Medical Center - Chapel Hill

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Cumberland Research Associates

Fayetteville, North Carolina, United States

Lucas Research

Morehead City, North Carolina, United States

Consultants for Clinical Research

Cincinnati, Ohio, United States

Aventiv Research - Columbus

Columbus, Ohio, United States

Awasty Research Network

Marion, Ohio, United States

Premier Medical Group - Clarksville

Clarksville, Tennessee, United States

Gastro One - Germantown - Centre Oak Way

Germantown, Tennessee, United States

Associates in Gastroenterology

Hermitage, Tennessee, United States

Gastrointestinal Associates - Knoxville

Knoxville, Tennessee, United States

South Texas Research Institute - Brownsville

Brownsville, Texas, United States

Dallas Research Center

Dallas, Texas, United States

Liver Center of Texas

Dallas, Texas, United States

Texas Digestive Disease Consultants - Dallas

Dallas, Texas, United States

The Liver Institute at Methodist Dallas Medical Center

Dallas, Texas, United States

South Texas Research Institute

Edinburg, Texas, United States

Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Texas Digestive Disease Consultants - Fort Worth

Fort Worth, Texas, United States

Liver Associates of Texas

Houston, Texas, United States

Doctor's Hospital at Renaissance

McAllen, Texas, United States

Plano Research Center

Plano, Texas, United States

Pinnacle Clinical Research - Austin

Rollingwood, Texas, United States

Pinnacle Clinical Research

San Antonio, Texas, United States

San Antonio Research Center

San Antonio, Texas, United States

The Texas Liver Institute

San Antonio, Texas, United States

Texas Digestive Disease Consultants - San Marcos

San Marcos, Texas, United States

Impact Research Institute

Waco, Texas, United States

Texas Digestive Disease Consultants - Bay Area Gastroenterology

Webster, Texas, United States

Wasatch Peak Family Practice

Layton, Utah, United States

Salt Lake City Research Center

Murray, Utah, United States

University of Utah Hospital

Salt Lake City, Utah, United States

University of Virginia Health System

Charlottesville, Virginia, United States

Bon Secours St. Mary's Hospital of Richmond

Richmond, Virginia, United States

Hunter Holmes McGuire Veterans Administration Medical Center

Richmond, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Liver Institute Northwest

Seattle, Washington, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

Saint Vincent's Hospital Sydney

Darlinghurst, New South Wales, Australia

Nepean Hospital

Kingswood, New South Wales, Australia

John Hunter Hospital

New Lambton, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Mater Misericordiae

South Brisbane, Queensland, Australia

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Monash Medical Centre

Clayton, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

And 147 more locations on ClinicalTrials.gov