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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

2024-02-20

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 (246)

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

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

The Alfred Hospital

Melbourne, Victoria, Australia

The Royal Melbourne Hospital

Parkville, Victoria, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Royal Perth Hospital

Perth, Western Australia, Australia

Klinikum Klagenfurt Am Wörthersee

Klagenfurt, Carinthia, Austria

Ordensklinikum Linz GmbH Barmherzige Schwestern

Linz, Upper Austria, Austria

Krankenanstalt Rudolfstiftung

Vienna, Vienna, Austria

Landesklinik St. Veit

Salzburg, Austria

Universitätsklinikum St. Pölten

Sankt Pölten, Austria

Medizinische Universität Wien

Vienna, Austria

Klinikum Wels-Grieskirchen

Wels, Austria

Universitair Ziekenhuis Antwerpen

Edegem, Antwerpen, Belgium

Hôpital Erasme

Brussels, Brussels Capital, Belgium

Universitair Ziekenhuis Leuven

Leuven, Flemish Brabant, Belgium

Ziekenhuis Oost-Limburg'

Genk, Limburg, Belgium

Algemeen Ziekenhuis Maria Middelares

Ghent, Oost-Vlaanderen, Belgium

Universitair Ziekenhuis Gent

Ghent, Oost-Vlaanderen, Belgium

AZ Delta Campus Wilgenstraat

Roeselare, West-Vlaanderen, Belgium

Universitair Ziekenhuis Brussel

Brussels, Belgium

Cliniques Universitaires Saint-Luc

Brussels, Belgium

Centre Hospitalier Universitaire Brugmann

Laken, Belgium

Universitair Ziekenhuis Leuven

Leuven, Belgium

University of Calgary Liver Unit

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

South Shore Medical Arts

Bridgewater, Nova Scotia, Canada

LMC/ Manna Research - Brampton

Brampton, Ontario, Canada

William Osler Health System

Brampton, Ontario, Canada

McMaster University

Hamilton, Ontario, Canada

Toronto General Hospital - Clinical Trials Pharmacy

Toronto, Ontario, Canada

Toronto Liver Center

Toronto, Ontario, Canada

Lair Centre

Vancouver, Canada

GI Research Institute

Vancouver, Canada

Les Hôpitaux Universitaires de Strasbourg - Hôpital Hautepierre

Strasbourg, Alsace, France

Nouvel Hôpital Civil

Strasbourg, Alsace, France

Hôpital de la Croix Rousse

Lyon, Auvergne-Rhône-Alpes, France

Centre Hospitalier Universitaire Estaing

Clermont-Ferrand, Auvergne, France

Centre Hospitalier Universitaire de Rennes

Rennes, Brittany Region, France

Hôpital Jean-Minjoz

Besançon, Franche-Comte, France

Centre Hospitalier Régional Universitaire de Lille

Lille, Hauts-de-France, France

Centre Hospitalier Universitaire de Montpellier

Montpellier, Languedoc-Roussillon, France

Hôpital Dupuytren

Limoges, Limousin, France

Centre Hospitalier Universitaire de Toulouse - Hôpital Rangueil

Toulouse, Midi-Pyrenees, France

Center Hospitalier Universitaire d'Angers

Angers, Pays de la Loire Region, France

Centre Hospitalier Universitaire de Nice Hôpital l'Archet

Nice, Provence-Alpes-Côte d'Azur Region, France

Centre Hospitalier Universitaire Amiens-Picardie

Amiens, France

Hôpital Beaujon

Clichy, France

Hôpital Universitaire Pitié Salpêtrière

Paris, France

Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois

Vandœuvre-lès-Nancy, France

Hôpital Avicenne

Bobigny, Île-de-France Region, France

Centre Hospitalier Universitaire Henri Mondor

Créteil, Île-de-France Region, France

Assistance Publique-Hôpitaux de Paris Hôpital Cochin

Paris, Île-de-France Region, France

Berlin Clinical Research Center

Berlin, Germany

Charité Universitätsmedizin Berlin - Campus Mitte

Berlin, Germany

Charité Universitätsmedizin Berlin

Berlin, Germany

EPIMED

Berlin, Germany

Zentrum für Infektiologie Berlin Prenzlauer Berg

Berlin, Germany

Frankfurt Clinical Research Center

Frankfurt am Main, Germany

Universitätsklinikum Frankfurt

Frankfurt am Main, Germany

Universitätsklinikum des Saarlandes

Homburg, Germany

EUGASTRO

Leipzig, Germany

Leipzig Research Center

Leipzig, Germany

SIBAmed Studienzentrum

Leipzig, Germany

Universitätsmedizin der Johannes Gutenberg Universität Mainz

Mainz, Germany

Universitätsklinikum Würzburg

Würzburg, Germany

Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház

Békéscsaba, Bekes County, Hungary

Magyarország Egészségügyi Szolgáltató - Gyula

Gyula, Bekes County, Hungary

Debreceni Egyetem Kenézy Gyula Egyetemi Kórház

Debrecen, Hajdú-Bihar, Hungary

Magyarország Research Center

Debrecen, Hajdú-Bihar, Hungary

Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház

Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary

Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet

Budapest, Hungary

Magyarország Research Center

Budapest, Hungary

The Chaim Sheba Medical Center

Ramat Gan, Tel Aviv, Israel

Emek Medical Center

Afula, Israel

Soroka University Medical Center

Beersheba, Israel

Rambam Health Care Campus - Rambam Medical Center

Haifa, Israel

The Lady Davis Carmel Medical Center

Haifa, Israel

Hadassah University Hospital Ein Kerem

Jerusalem, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Western Galilee Hospital-Nahariya

Nahariya, Israel

Holy Family Hospital

Nazareth, Israel

Rabin Medical Center

Petah Tikva, Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Azienda Ospedaliera Papa Giovanni XXIII

Bergamo, Italy

Azienda Ospedaliero - Universitaria Careggi

Florence, Italy

Azienda Ospedaliera Universitaria Policlinico Gaetano Martino

Messina, Italy

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

Milan, Italy

Polo Universitario - L'Azienda Ospedaliera Luigi Sacco

Milan, Italy

Azienda Ospedaliera Universitaria-Maggiore della Carità di Novara

Novara, Italy

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Palermo, Italy

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

Palermo, Italy

Azienda Ospedaliero-Universitaria Pisana Ospedale Cisanello

Pisa, Italy

Fondazione Policlinico Universitario Agostino Gemelli

Roma, Italy

Universita degli Studi di Roma La Sapienza - Umberto I Policlinico di Roma

Roma, Italy

Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

Centro Integral en Reumatología

Guadalajara, Jalisco, Mexico

Centro Mexicano de Desarrollo de Estudios Clínicos

Mexico City, Mexico City, Mexico

Centro de Investigacion y Gastroenterologia

Mexico City, Mexico City, Mexico

JM Research

Cuernavaca, Morelos, Mexico

Investigaciones Médicas Cisneros

Monterrey, Nuevo León, Mexico

Polska Oddział w Częstochowie

Częstochowa, Poland

Polska Oddział w Gdansk

Gdansk, Poland

Polska Oddział w Gdyni

Gdynia, Poland

Polska Oddział w Katowicach

Katowice, Poland

Polska Oddział w Łodz

Lodz, Poland

Polska Oddział w Poznaniu

Poznan, Poland

Centrum Medyczne Pratia Poznan

Skórzewo, Poland

Polska Oddział w Warszawie

Warsaw, Poland

Polska Oddział w Wrocław

Wroclaw, Poland

Fundación De Investigación De Diego

San Juan, Puerto Rico

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, Spain

Complejo Hospitalario Torrecárdenas

Almería, Spain

Hospital de la Santa Creu i de Sant Pau

Barcelona, Spain

Hospital del Mar - Parc de Salut Mar

Barcelona, Spain

Hospital Universitari Vall d'Hebrón

Barcelona, Spain

Hospital General Universitario Gregorio Marañón

Madrid, Spain

Hospital Universitario Ramón Y Cajal

Madrid, Spain

Complejo Hospitalario de Pontevedra

Pontevedra, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Hospital Universitario Virgen del Rocio

Seville, Spain

Consorci Hospital General Universitari de València

Valencia, Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain

Universitatsspital Bern

Bern, Switzerland

Fondazione Epatocentro Ticino

Lugano, Switzerland

Universitatsspital Zurich

Zurich, Switzerland

Midlands Clinical Research Centre

Birmingham, England, United Kingdom

University Hospitals Birmingham NHS Foundation Trust

Birmingham, England, United Kingdom

Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, United Kingdom

Lancashire Clinical Research Centre

Chorley, England, United Kingdom

North Teesside Clinical Research Centre

Hardwick, England, United Kingdom

Merseyside Clinical Research Centre

Liverpool, England, United Kingdom

Barts Health NHS Trust

London, England, United Kingdom

Chelsea and Westminster Hospital NHS Foundation Trust

London, England, United Kingdom

Imperial College Healthcare NHS Trust

London, England, United Kingdom

Royal Free London NHS Foundation Trust

London, England, United Kingdom

Manchester Clinical Research Centre

Manchester, England, United Kingdom

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, England, United Kingdom

Norfolk and Norwich University Hospital

Norwich, England, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, England, United Kingdom

Thames Valley Dedicated Research Centre

Reading, England, United Kingdom

Belfast Health and Social Care Trust

Belfast, Northern Ireland, United Kingdom

The Hexham Clinic

Hexham, Northumberland, England, United Kingdom

The Wales Clinic

Cardiff, Wales, United Kingdom

Abertawe Bro Morgannwg University Health Board

Swansea, Wales, United Kingdom

Aintree University Hospitals NHS Foundation Trust

Liverpool, United Kingdom

Saint George's University Hospitals NHS Foundation Trust

London, United Kingdom

Plymouth Hospitals NHS Trust

Plymouth, United Kingdom

Portsmouth Hospitals NHS Trust

Portsmouth, United Kingdom