Clinical Trial Details

Trial ID: L0283
Source ID: NCT03900429
Associated Drug: Resmetirom
Title: A Phase 3 Study to Evaluate the Efficacy and Safety of MGL-3196 (Resmetirom) in Patients With NASH and Fibrosis
Acronym: MAESTRO-NASH
Status: Recruiting
Study Results: No Results Available
Results: --
Conditions: NASH - Nonalcoholic Steatohepatitis
Interventions: Drug: MGL-3196|Drug: Placebo
Outcome Measures: To evaluate the effect of MGL-3196 80 mg or 100 mg compared to placebo to achieve NASH resolution on liver histology in non-cirrhotic NASH patients with stage 2 or 3 fibrosis|Composite long-term outcome events composed of all-cause mortality, cirrhosis, and other significant liver-related events|To determine the effect of once-daily, oral administration of MGL-3196 80 or 100 mg versus matching placebo on the percent change from Baseline at 24 weeks in low-density lipoprotein cholesterol (LDL-C)|To evaluate the effect of MGL-3196 80 mg or 100 mg compared to placebo to achieve improvement in fibrosis on liver histology in non-cirrhotic NASH patients with stage 2 or 3 fibrosis
Sponsor/Collaborators: Madrigal Pharmaceuticals, Inc.
Gender: All
Age: 18 Years and older ?? (Adult, Older Adult)
Phases: Phase 3
Enrollment: 2000
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Start Date: March 28, 2019
Completion Date: March 2024
Results First Posted: --
Last Update Posted: July 7, 2021
Locations: 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|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|University of Florida Hepatology Research at CTRB, Gainesville, Florida, United States|Nature Coast Clinical Research, Inverness, Florida, United States|Florida Research Institute, Lakewood Ranch, 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|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|Gastrointestinal Associates and Endoscopy Center - Madison, Flowood, Mississippi, United States|Southern Therapy and Advanced Research, Jackson, Mississippi, United States|Kansas City Research Institute, Kansas City, Missouri, United States|Saint Louis University, Saint Louis, Missouri, United States|Clinical Research US - Henderson, Henderson, Nevada, United States|Mt. Sinai Medical Center, New York, New York, 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|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|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 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 W??rthersee, Klagenfurt, Carinthia, Austria|Ordensklinikum Linz GmbH Barmherzige Schwestern, Linz, Upper Austria, Austria|Krankenanstalt Rudolfstiftung, Wien, Vienna, Austria|Landesklinik St. Veit, Salzburg, Austria|Medizinische Universit??t Wien, Vienna, Austria|Klinikum Wels-Grieskirchen, Wels, Austria|Universitair Ziekenhuis Antwerpen, Edegem, Antwerpen, Belgium|H??pital Erasme, Bruxelles, Brussels, Belgium|Universitair Ziekenhuis Leuven, Leuven, Flemish Brabant, Belgium|Ziekenhuis Oost-Limburg', Genk, Limburg, Belgium|Algemeen Ziekenhuis Maria Middelares, Gent, Oost-Vlaanderen, Belgium|Universitair Ziekenhuis Gent, Gent, Oost-Vlaanderen, Belgium|AZ Delta Campus Wilgenstraat, Roeselare, West-Vlaanderen, Belgium|Cliniques Universitaires Saint-Luc, Brussels, Belgium|Centre Hospitalier Universitaire Brugmann, Laeken, 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|GI Research Institute, Vancouver, Canada|Nouvel H??pital Civil, Strasbourg Cedex, Alsace, France|Les H??pitaux Universitaires de Strasbourg - H??pital Hautepierre, Strasbourg, Alsace, France|Centre Hospitalier Universitaire Estaing, Clermont-Ferrand, Auvergne, France|Centre Hospitalier Universitaire de Rennes, Rennes Cedex 9, Bretagne, France|H??pital Jean-Minjoz, Besan??on, Franche-Comte, France|H??pital Avicenne, Bobigny Cedex, Ile-de-France, France|Centre Hospitalier Universitaire Henri Mondor, Cr??teil Cedex, Ile-de-France, France|Assistance Publique-H??pitaux de Paris H??pital Cochin, Paris Cedex 14, Ile-de-France, France|Centre Hospitalier Universitaire de Montpellier, Montpellier Cedex 5, Languedoc-Roussillon, France|H??pital Dupuytren, Limoges, Limousin, France|Centre Hospitalier Universitaire de Toulouse - H??pital Rangueil, Toulouse Cedex, Midi-Pyrenees, France|Centre Hospitalier R??gional Universitaire de Lille, Lille, Nord Pas-de-Calais, France|Center Hospitalier Universitaire d'Angers, Angers, Pays De La Loire, France|Centre Hospitalier Universitaire de Nice H??pital l'Archet, Nice Cedex 3, Provence Alpes Cote D'Azur, France|H??pital de la Croix Rousse, Lyon Cedex 04, Rhone-Alpes, France|Centre Hospitalier Universitaire Amiens-Picardie, Amiens, France|H??pital Beaujon, Clichy, France|H??pital Universitaire Piti?? Salp??tri??re, Paris Cedex 13, France|Centre Hospitalier Universitaire de Nancy - H??pital de Brabois, Vand??uvre-l??s-Nancy, France|Berlin Clinical Research Center, Berlin, Germany|Charit?? Universit??tsmedizin Berlin - Campus Mitte, Berlin, Germany|Charit?? Universit??tsmedizin Berlin, Berlin, Germany|EPIMED, Berlin, Germany|Zentrum f??r Infektiologie Berlin Prenzlauer Berg, Berlin, Germany|Frankfurt Clinical Research Center, Frankfurt am main, Germany|Universit??tsklinikum Frankfurt, Frankfurt am main, Germany|Universit??tsklinikum des Saarlandes, Homburg, Germany|EUGASTRO, Leipzig, Germany|Leipzig Research Center, Leipzig, Germany|SIBAmed Studienzentrum, Leipzig, Germany|Universit??tsklinikum W??rzburg, W??rzburg, Germany|B??k??s Megyei K??zponti K??rh??z Dr. R??thy P??l Tagk??rh??z, B??k??scsaba, Bekes, Hungary|Magyarorsz??g Eg??szs??g??gyi Szolg??ltat?? - Gyula, Gyula, Bekes, Hungary|Debreceni Egyetem Ken??zy Gyula Egyetemi K??rh??z, Debrecen, Hajdu-Bihar, Hungary|Magyarorsz??g Research Center, Debrecen, Hajdu-Bihar, Hungary|Szabolcs-Szatm??r-Bereg Megyei K??rh??zak ??s Egyetemi Oktat??k??rh??z, Ny??regyh??za, Szabolcs-Szatmar-Bereg, Hungary|D??l-pesti Centrumk??rh??z - Orsz??gos Hematol??giai ??s Infektol??giai Int??zet, Budapest, Hungary|Magyarorsz??g Research Center, Budapest, Hungary|The Chaim Sheba Medical Center, Ramat Gan, Tel Aviv, Israel|Emek Medical Center, Afula, Israel|Soroka University Medical Center, Be'er Sheva, 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, Firenze, Italy|Azienda Ospedaliera Universitaria Policlinico Gaetano Martino, Messina, Italy|Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milano, Italy|Polo Universitario - L'Azienda Ospedaliera Luigi Sacco, Milano, Italy|Azienda Ospedaliera Universitaria-Maggiore della Carit?? 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|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|Polska Oddzia?? w Cz??stochowie, Cz??stochowa, Poland|Polska Oddzia?? w Gdansk, Gda??sk, Poland|Polska Oddzia?? w Gdyni, Gdynia, Poland|Polska Oddzia?? w Katowicach, Katowice, Poland|Polska Oddzia?? w Poznaniu, Pozna??, Poland|Polska Oddzia?? w Warszawie, Warszawa, Poland|Polska Oddzia?? w Wroc??aw, Wroc??aw, Poland|Polska Oddzia?? w ??odz, ????d??, Poland|Fundaci??n De Investigaci??n De Diego, San Juan, Puerto Rico|Hospital Universitario Puerta de Hierro - Majadahonda, Majadahonda, Madrid, Spain|Complejo Hospitalario Torrec??rdenas, Almeria, 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'Hebr??n, Barcelona, Spain|Hospital General Universitario Gregorio Mara????n, Madrid, Spain|Hospital Universitario Ram??n Y Cajal, Madrid, Spain|Complejo Hospitalario de Pontevedra, Pontevedra, Spain|Hospital Universitario Marqu??s de Valdecilla, Santander, Spain|Hospital Universitario Virgen del Rocio, Sevilla, Spain|Consorci Hospital General Universitari de Val??ncia, Valencia, Spain|Hospital Universitari i Politecnic La Fe de Valencia, Valencia, Spain|Universitatsspital Bern, Bern, Switzerland|Fondazione Epatocentro Ticino, Lugano, Switzerland|Universitatsspital Zurich, Z??rich, 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
URL: https://ClinicalTrials.gov/show/NCT03900429