A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
NCT ID: NCT03900429
Last Updated: 2024-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1759 participants
INTERVENTIONAL
2019-03-28
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Matching Placebo
Placebo Daily
Placebo
Matching Tablets
Liver Biopsy
A procedure in which a needle is inserted into the liver to collect a tissue sample
80 mg MGL-3196
80 mg daily
MGL-3196
Tablet
Liver Biopsy
A procedure in which a needle is inserted into the liver to collect a tissue sample
100 mg MGL-3196
100 mg daily
MGL-3196
Tablet
Liver Biopsy
A procedure in which a needle is inserted into the liver to collect a tissue sample
Interventions
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MGL-3196
Tablet
Placebo
Matching Tablets
Liver Biopsy
A procedure in which a needle is inserted into the liver to collect a tissue sample
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male and female adults ≥ 18 years of age.
3. Suspected or confirmed diagnosis of NASH fibrosis suggested by the historical data. Meet one of the following criteria that is consistent with NASH liver fibrosis:
1. Historical biochemical test for fibrosis: PRO-C3 \>14 ng/mL or ELF ≥9
2. FibroScan with transient elastography ≥8.5 kPa and controlled attenuation parameter ≥280 dB.m-1
3. Historical liver biopsy obtained \<2 years before expected randomization showing Stage 1B, 2 or 3 fibrosis with NASH based on existing pathology review, with no significant change in body weight \>5% or medication that might affect NAS or fibrosis stage.
4. MRI-PDFF fat fraction ≥8% obtained during the screening period
5. Biopsy-proven NASH (baseline liver biopsy) based on a liver biopsy obtained ≤6 months before anticipated date of randomization (if the biopsy is deemed acceptable for interpretation by the central reader) with fibrosis stage 1A/1C, 1B, 2, or 3 on liver biopsy and NAS of ≥4 with a score of at least 1 in each of the following NAS components:
1. Steatosis (scored 0 to 3)
2. Ballooning degeneration (scored 0 to 2)
3. Lobular inflammation (scored 0 to 3)
Exclusion Criteria
2. Regular use of drugs historically associated with NAFLD
3. Thyroid diseases:
1. Active hyperthyroidism.
2. Untreated clinical hypothyroidism defined by thyroid stimulating hormone (TSH) \>7 IU/L with symptoms of hypothyroidism or \>10 IU/L without symptoms.
3. Patients who have had a thyroidectomy and are on replacement thyroxine doses \>75 µg per day are allowed.
4. History of bariatric surgery or intestinal bypass surgery within the 5 years prior to randomization or planned during the conduct of the study.
5. Recent significant weight gain or loss
6. HbA1c ≥ 9.0%.
7. Glucagon-like peptide 1 \[GLP-1\] agonist, high dose Vitamin E (\> 400 IU/day), or pioglitazone therapy unless stable dose for 24 weeks prior to biopsy.
8. Presence of cirrhosis on liver biopsy defined as stage 4 fibrosis.
9. Diagnosis of hepatocellular carcinoma (HCC).
10. MELD score ≥12, as determined at Screening, unless due to therapeutic anti coagulation.
11. Hepatic decompensation
12. Chronic liver diseases other than NASH
13. Active autoimmune disease
14. Serum ALT \> 250 U/L.
15. Active, serious medical disease with a likely life expectancy \< 2 years.
16. Participation in an investigational new drug trial in the 60 days or 5 half-lives, whichever is longer.
17. Any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes.
18 Years
ALL
No
Sponsors
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Madrigal Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Rebecca Taub, MD
Role: STUDY_DIRECTOR
Madrigal Pharmaceuticals, Inc.
Locations
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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
Countries
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References
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Noureddin M, Rinella M, Taub R, Labriola D, Camacho RC, Alkhouri N, Loomba R, Bansal MB. Effects of Resmetirom on Metabolic-Dysfunction Associated Steatohepatitis in Patients With Weight Loss and/or Diabetes Taking Glucagon-Like Peptide-1 Receptor Agonists and Other Diabetes Therapies: A Secondary Analysis of the MAESTRO-NASH Trial. Aliment Pharmacol Ther. 2025 Oct 23. doi: 10.1111/apt.70382. Online ahead of print.
Harrison SA, Bedossa P, Guy CD, Schattenberg JM, Loomba R, Taub R, Labriola D, Moussa SE, Neff GW, Rinella ME, Anstee QM, Abdelmalek MF, Younossi Z, Baum SJ, Francque S, Charlton MR, Newsome PN, Lanthier N, Schiefke I, Mangia A, Pericas JM, Patil R, Sanyal AJ, Noureddin M, Bansal MB, Alkhouri N, Castera L, Rudraraju M, Ratziu V; MAESTRO-NASH Investigators. A Phase 3, Randomized, Controlled Trial of Resmetirom in NASH with Liver Fibrosis. N Engl J Med. 2024 Feb 8;390(6):497-509. doi: 10.1056/NEJMoa2309000.
Harrison SA, Ratziu V, Anstee QM, Noureddin M, Sanyal AJ, Schattenberg JM, Bedossa P, Bashir MR, Schneider D, Taub R, Bansal M, Kowdley KV, Younossi ZM, Loomba R. Design of the phase 3 MAESTRO clinical program to evaluate resmetirom for the treatment of nonalcoholic steatohepatitis. Aliment Pharmacol Ther. 2024 Jan;59(1):51-63. doi: 10.1111/apt.17734. Epub 2023 Oct 2.
Harrison SA, Bashir M, Moussa SE, McCarty K, Pablo Frias J, Taub R, Alkhouri N. Effects of Resmetirom on Noninvasive Endpoints in a 36-Week Phase 2 Active Treatment Extension Study in Patients With NASH. Hepatol Commun. 2021 Jan 4;5(4):573-588. doi: 10.1002/hep4.1657. eCollection 2021 Apr.
Other Identifiers
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MGL-3196-11
Identifier Type: -
Identifier Source: org_study_id
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