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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,759

Participants

Timeline

Start Date

March 28, 2019

Primary Completion Date

January 31, 2028

Study Completion Date

January 31, 2028

Conditions
NASH - Nonalcoholic Steatohepatitis
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

Trial Locations (246)

1090

Universitair Ziekenhuis Brussel, Brussels

2010

Saint Vincent's Hospital Sydney, Darlinghurst

2050

Royal Prince Alfred Hospital, Camperdown

2145

Westmead Hospital, Westmead

2305

John Hunter Hospital, New Lambton

2747

Nepean Hospital, Kingswood

3004

The Alfred Hospital, Melbourne

3050

The Royal Melbourne Hospital, Parkville

3084

Austin Health, Heidelberg

3100

Universitätsklinikum St. Pölten, Sankt Pölten

3168

Monash Medical Centre, Clayton

4029

Royal Brisbane and Women's Hospital, Herston

4101

Mater Misericordiae, South Brisbane

5000

Royal Adelaide Hospital, Adelaide

6000

Royal Perth Hospital, Perth

6009

Sir Charles Gairdner Hospital, Nedlands

10029

Mt. Sinai Medical Center, New York

10065

New York Presbyterian Hospital, New York

20889

Walter Reed National Military Medical Center, Bethesda

22903

University of Virginia Health System, Charlottesville

23226

Bon Secours St. Mary's Hospital of Richmond, Richmond

23249

Hunter Holmes McGuire Veterans Administration Medical Center, Richmond

Virginia Commonwealth University, Richmond

27599

University of North Carolina Medical Center - Chapel Hill, Charlotte

27705

Duke University Medical Center, Durham

28304

Cumberland Research Associates, Fayetteville

28557

Lucas Research, Morehead City

30060

GI Specialists of Georgia, Marietta

32127

Progressive Medical Research, Port Orange

32162

Bioclinica Research - The Villages, The Villages

32610

University of Florida Hepatology Research at CTRB, Gainesville

32806

Bioclinica Research - Orlando, Orlando

33136

University of Miami, Miami

33176

Miami Dade Medical Research Institute, Miami

33434

Excel Medical Clinical Trials, Boca Raton

33912

Covenant Metabolic Specialists - Fort Myers, Fort Myers

34211

Florida Research Institute, Lakewood Rch

34240

Covenant Research, Sarasota

34452

Nature Coast Clinical Research, Inverness

35249

University of Alabama at Birmingham, Birmingham

37040

Premier Medical Group - Clarksville, Clarksville

37076

Associates in Gastroenterology, Hermitage

37909

Gastrointestinal Associates - Knoxville, Knoxville

38138

Gastro One - Germantown - Centre Oak Way, Germantown

39216

Southern Therapy and Advanced Research, Jackson

39232

Gastrointestinal Associates and Endoscopy Center - Madison, Flowood

43213

Aventiv Research - Columbus, Columbus

43302

Awasty Research Network, Marion

44160

Centro Integral en Reumatología, Guadalajara

45249

Consultants for Clinical Research, Cincinnati

55131

Universitätsmedizin der Johannes Gutenberg Universität Mainz, Mainz

56124

Azienda Ospedaliero-Universitaria Pisana Ospedale Cisanello, Pisa

60602

Clinical Research - Chicago, Chicago

60611

Northwestern Medical Faculty Foundation, Chicago

60637

The University of Chicago Medicine, Chicago

62290

JM Research, Cuernavaca

63104

Saint Louis University, St Louis

64000

Investigaciones Médicas Cisneros, Monterrey

64111

Saint Luke's Hospital of Kansas City, Kansas City

64131

Kansas City Research Institute, Kansas City

66205

University of Kansas Medical Center Research Institute, Fairway

66606

Kansas Medical Clinic - Gastroenterology, Topeka

70072

Tandem Clinical Research, Marrero

70112

Tulane University School of Medicine, New Orleans

70121

Ochsner Medical Center, New Orleans

70809

Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge, Baton Rouge

71291

Clinical Trials of America, West Monroe

72117

Arkansas Gastroenterology, North Little Rock

75093

Plano Research Center, Plano

75234

Dallas Research Center, Dallas

Liver Center of Texas, Dallas

Texas Digestive Disease Consultants - Dallas, Dallas

The Liver Institute at Methodist Dallas Medical Center, Dallas

76104

Texas Digestive Disease Consultants - Fort Worth, Fort Worth

76710

Impact Research Institute, Waco

77030

Liver Associates of Texas, Houston

77598

Texas Digestive Disease Consultants - Bay Area Gastroenterology, Webster

78229

Pinnacle Clinical Research, San Antonio

San Antonio Research Center, San Antonio

The Texas Liver Institute, San Antonio

78234

Brooke Army Medical Center, Fort Sam Houston

78504

Doctor's Hospital at Renaissance, McAllen

78520

South Texas Research Institute - Brownsville, Brownsville

78539

South Texas Research Institute, Edinburg

78666

Texas Digestive Disease Consultants - San Marcos, San Marcos

78746

Pinnacle Clinical Research - Austin, Rollingwood

80113

South Denver Gastroenterology - Swedish Medical Center Office, Englewood

80909

Colorado Springs Family Practice, Colorado Springs

84041

Wasatch Peak Family Practice, Layton

84123

Salt Lake City Research Center, Murray

84132

University of Utah Hospital, Salt Lake City

85213

Desert Clinical Research, Mesa

85224

East Valley Family Physicians, Chandler

The Institute for Liver Health - Chandler, Chandler

85306

The Institute for Liver Health - Glendale, Glendale

85712

Adobe Gastroenterology, Tucson

The Institute for Liver Health - Tucson, Tucson

89052

Clinical Research US - Henderson, Henderson

90048

Cedars-Sinai Medical Center, Los Angeles

90057

National Research Institute - Los Angeles, Los Angeles

Ruane Clinical Research, Los Angeles

90255

National Research Institute - Huntington Park, Huntington Park

91402

National Research Institute - Panorama City, Panorama City

91405

San Fernando Valley Health Institute, Van Nuys

92037

University of California San Diego, La Jolla

92064

Alliance Clinical Research, Poway

93720

Fresno Clinical Research Center, Fresno

94304

Stanford University School of Medicine, Palo Alto

98105

Liver Institute Northwest, Seattle

02215

Beth Israel Deaconess Medical Center, Boston

Unknown

Klinikum Klagenfurt Am Wörthersee, Klagenfurt

Ordensklinikum Linz GmbH Barmherzige Schwestern, Linz

Krankenanstalt Rudolfstiftung, Vienna

Landesklinik St. Veit, Salzburg

Medizinische Universität Wien, Vienna

Klinikum Wels-Grieskirchen, Wels

Universitair Ziekenhuis Antwerpen, Edegem

Hôpital Erasme, Brussels

Universitair Ziekenhuis Leuven, Leuven

Ziekenhuis Oost-Limburg', Genk

Algemeen Ziekenhuis Maria Middelares, Ghent

Universitair Ziekenhuis Gent, Ghent

AZ Delta Campus Wilgenstraat, Roeselare

Cliniques Universitaires Saint-Luc, Brussels

Centre Hospitalier Universitaire Brugmann, Laken

Universitair Ziekenhuis Leuven, Leuven

University of Calgary Liver Unit, Calgary

University of Alberta, Edmonton

South Shore Medical Arts, Bridgewater

LMC/ Manna Research - Brampton, Brampton

William Osler Health System, Brampton

McMaster University, Hamilton

Toronto General Hospital - Clinical Trials Pharmacy, Toronto

Toronto Liver Center, Toronto

GI Research Institute, Vancouver

Les Hôpitaux Universitaires de Strasbourg - Hôpital Hautepierre, Strasbourg

Nouvel Hôpital Civil, Strasbourg

Hôpital de la Croix Rousse, Lyon

Centre Hospitalier Universitaire Estaing, Clermont-Ferrand

Centre Hospitalier Universitaire de Rennes, Rennes

Hôpital Jean-Minjoz, Besançon

Centre Hospitalier Régional Universitaire de Lille, Lille

Centre Hospitalier Universitaire de Montpellier, Montpellier

Hôpital Dupuytren, Limoges

Centre Hospitalier Universitaire de Toulouse - Hôpital Rangueil, Toulouse

Center Hospitalier Universitaire d'Angers, Angers

Centre Hospitalier Universitaire de Nice Hôpital l'Archet, Nice

Centre Hospitalier Universitaire Amiens-Picardie, Amiens

Hôpital Beaujon, Clichy

Hôpital Universitaire Pitié Salpêtrière, Paris

Centre Hospitalier Universitaire de Nancy - Hôpital de Brabois, Vandœuvre-lès-Nancy

Hôpital Avicenne, Bobigny

Centre Hospitalier Universitaire Henri Mondor, Créteil

Assistance Publique-Hôpitaux de Paris Hôpital Cochin, Paris

Berlin Clinical Research Center, Berlin

Charité Universitätsmedizin Berlin - Campus Mitte, Berlin

Charité Universitätsmedizin Berlin, Berlin

EPIMED, Berlin

Zentrum für Infektiologie Berlin Prenzlauer Berg, Berlin

Frankfurt Clinical Research Center, Frankfurt am Main

Universitätsklinikum Frankfurt, Frankfurt am Main

Universitätsklinikum des Saarlandes, Homburg

EUGASTRO, Leipzig

Leipzig Research Center, Leipzig

SIBAmed Studienzentrum, Leipzig

Universitätsklinikum Würzburg, Würzburg

Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház, Békéscsaba

Magyarország Egészségügyi Szolgáltató - Gyula, Gyula

Debreceni Egyetem Kenézy Gyula Egyetemi Kórház, Debrecen

Magyarország Research Center, Debrecen

Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Nyíregyháza

Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet, Budapest

Magyarország Research Center, Budapest

The Chaim Sheba Medical Center, Ramat Gan

Emek Medical Center, Afula

Soroka University Medical Center, Beersheba

Rambam Health Care Campus - Rambam Medical Center, Haifa

The Lady Davis Carmel Medical Center, Haifa

Hadassah University Hospital Ein Kerem, Jerusalem

Shaare Zedek Medical Center, Jerusalem

Western Galilee Hospital-Nahariya, Nahariya

Holy Family Hospital, Nazareth

Rabin Medical Center, Petah Tikva

Tel Aviv Sourasky Medical Center, Tel Aviv

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo

Azienda Ospedaliero - Universitaria Careggi, Florence

Azienda Ospedaliera Universitaria Policlinico Gaetano Martino, Messina

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan

Polo Universitario - L'Azienda Ospedaliera Luigi Sacco, Milan

Azienda Ospedaliera Universitaria-Maggiore della Carità di Novara, Novara

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo

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

Fondazione Policlinico Universitario Agostino Gemelli, Roma

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

Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo

Polska Oddział w Częstochowie, Częstochowa

Polska Oddział w Gdansk, Gdansk

Polska Oddział w Gdyni, Gdynia

Polska Oddział w Katowicach, Katowice

Polska Oddział w Łodz, Lodz

Polska Oddział w Poznaniu, Poznan

Polska Oddział w Warszawie, Warsaw

Polska Oddział w Wrocław, Wroclaw

Fundación De Investigación De Diego, San Juan

Hospital Universitario Puerta de Hierro - Majadahonda, Majadahonda

Complejo Hospitalario Torrecárdenas, Almería

Hospital de la Santa Creu i de Sant Pau, Barcelona

Hospital del Mar - Parc de Salut Mar, Barcelona

Hospital Universitari Vall d'Hebrón, Barcelona

Hospital General Universitario Gregorio Marañón, Madrid

Hospital Universitario Ramón Y Cajal, Madrid

Complejo Hospitalario de Pontevedra, Pontevedra

Hospital Universitario Marqués de Valdecilla, Santander

Hospital Universitario Virgen del Rocio, Seville

Consorci Hospital General Universitari de València, Valencia

Hospital Universitari i Politecnic La Fe de Valencia, Valencia

Universitatsspital Bern, Bern

Fondazione Epatocentro Ticino, Lugano

Universitatsspital Zurich, Zurich

Midlands Clinical Research Centre, Birmingham

University Hospitals Birmingham NHS Foundation Trust, Birmingham

Cambridge University Hospitals NHS Foundation Trust, Cambridge

Lancashire Clinical Research Centre, Chorley

North Teesside Clinical Research Centre, Hardwick

Merseyside Clinical Research Centre, Liverpool

Barts Health NHS Trust, London

Chelsea and Westminster Hospital NHS Foundation Trust, London

Imperial College Healthcare NHS Trust, London

Royal Free London NHS Foundation Trust, London

Manchester Clinical Research Centre, Manchester

The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne

Norfolk and Norwich University Hospital, Norwich

Nottingham University Hospitals NHS Trust, Nottingham

Thames Valley Dedicated Research Centre, Reading

Belfast Health and Social Care Trust, Belfast

The Hexham Clinic, Hexham

The Wales Clinic, Cardiff

Abertawe Bro Morgannwg University Health Board, Swansea

Aintree University Hospitals NHS Foundation Trust, Liverpool

Saint George's University Hospitals NHS Foundation Trust, London

Plymouth Hospitals NHS Trust, Plymouth

Portsmouth Hospitals NHS Trust, Portsmouth

V5Z 1J4

Lair Centre, Vancouver

06100

Centro Mexicano de Desarrollo de Estudios Clínicos, Mexico City

06700

Centro de Investigacion y Gastroenterologia, Mexico City

60-185

Centrum Medyczne Pratia Poznan, Skórzewo

Sponsors
All Listed Sponsors
lead

Madrigal Pharmaceuticals, Inc.

INDUSTRY

NCT03900429 - A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis | Biotech Hunter | Biotech Hunter