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A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017)
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers are looking for ways to treat a type of liver disease caused by elevated liver fat, called metabolic dysfunction-associated steatohepatitis (MASH). MASH was formerly called non-alcoholic steatohepatitis (NASH). Researchers want to learn if a study medicine called efinopegdutide can treat MASH.The goals of this study are to learn: * If efinopegdutide can lower the amount of fat, inflammation, and scarring (fibrosis) in the liver * About the safety of efinopegdutide and how well people tolerate it
Official title: Phase 2a Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults With Compensated Cirrhosis Secondary to Metabolic Dysfunction-Associated Steatohepatitis
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-07-12
Completion Date
2026-08-06
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
Efinopegdutide
Efinopegdutide is given as a subcutaneous injection using a single-use prefilled syringe, once per week for 28 weeks
Placebo
Placebo is given as a subcutaneous injection using a single-use prefilled syringe once per week for 28 weeks.
Locations (68)
The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0149)
Chandler, Arizona, United States
Arizona Clinical Trials ( Site 0158)
Flagstaff, Arizona, United States
The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0120)
Peoria, Arizona, United States
The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 0111)
Tucson, Arizona, United States
California Liver Research Institute ( Site 0113)
Pasadena, California, United States
Acclaim Clinical Research ( Site 0137)
San Diego, California, United States
Velocity Clinical Research, Panorama City ( Site 0124)
Van Nuys, California, United States
Rocky Mountain Gastroenterology ( Site 0127)
Littleton, Colorado, United States
Synergy Healthcare ( Site 0118)
Bradenton, Florida, United States
Homestead Associates in Research, Inc. ( Site 0139)
Homestead, Florida, United States
Florida Research Institute ( Site 0116)
Lakewood Rch, Florida, United States
Floridian Clinical Research, LLC ( Site 0109)
Miami Lakes, Florida, United States
Southeast Clinical Research Center ( Site 0119)
Dalton, Georgia, United States
Delta Research Partners ( Site 0160)
Bastrop, Louisiana, United States
Louisiana Research Center ( Site 0161)
Shreveport, Louisiana, United States
Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 0130)
Glen Burnie, Maryland, United States
Velocity Clinical Research Rockville ( Site 0143)
Rockville, Maryland, United States
Huron Gastroenterology ( Site 0102)
Ypsilanti, Michigan, United States
The Machuca Foundation ( Site 0115)
Las Vegas, Nevada, United States
Excel Clinical Research, LLC ( Site 0101)
Las Vegas, Nevada, United States
Southwest Gastroenterology Associates ( Site 0129)
Albuquerque, New Mexico, United States
Coastal Research Institute - Fayetteville ( Site 0159)
Fayetteville, North Carolina, United States
Lucas Research, Inc ( Site 0105)
Morehead City, North Carolina, United States
Texas Clinical Research Institute ( Site 0126)
Arlington, Texas, United States
Pinnacle Clinical Research ( Site 0104)
Austin, Texas, United States
Pinnacle Clinical Research-Corpus Christi ( Site 0156)
Corpus Christi, Texas, United States
Zenos Clinical Research ( Site 0136)
Dallas, Texas, United States
GI Alliance Department of Research ( Site 0162)
Fort Worth, Texas, United States
Houston Research Institute ( Site 0172)
Houston, Texas, United States
Houston Research Institute ( Site 0117)
Houston, Texas, United States
American Research Corporation ( Site 0131)
San Antonio, Texas, United States
Pinnacle Clinical Research-Clinical Research Coordination ( Site 0125)
San Antonio, Texas, United States
University of Virginia Health System ( Site 0164)
Charlottesville, Virginia, United States
Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 1202)
Adelaide, South Australia, Australia
St Vincent's Hospital-Gastroenterology Department ( Site 1205)
Melbourne, Victoria, Australia
Toronto General Hospital ( Site 0207)
Toronto, Ontario, Canada
Diex Recherche Quebec ( Site 0204)
Québec, Quebec, Canada
Fundacion Santa Fe de Bogota ( Site 0403)
Bogotá, Cundinamarca, Colombia
Fundación Valle del Lili ( Site 0402)
Cali, Valle del Cauca Department, Colombia
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Pôle de Référence Hépato Gastro-entérol ( Site 0704)
Nice, Alpes-Maritimes, France
CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0701)
Pessac, Aquitaine, France
Hôpital de la Croix Rousse-Centre de Recherche Clinique ( Site 0705)
Lyon, Auvergne-Rhône-Alpes, France
Hôpital Beaujon-Hépatologie ( Site 0703)
Clichy, Hauts-de-Seine, France
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-Hépato-gastroentérologie ( Site 0702)
Limoges, Limousin, France
Rambam Health Care Campus ( Site 0801)
Haifa, Israel
Carmel Hospital-Liver Unit ( Site 0802)
Haifa, Israel
Shaare Zedek Medical Center ( Site 0805)
Jerusalem, Israel
Maccabi Health Services - Petah Tikva ( Site 0804)
Petah Tikva, Israel
Assuta Medical Center ( Site 0806)
Tel Aviv, Israel
Shinyurigaoka General Hospital ( Site 1401)
Kawasaki, Kanagawa, Japan
Yokohama City University Hospital ( Site 1402)
Yokohama, Kanagawa, Japan
University Hospital,Kyoto Prefectural University of Medicine ( Site 1404)
Kyoto, Japan
Osaka Metropolitan University Hospital ( Site 1403)
Osaka, Japan
Saga University Hospital ( Site 1405)
Saga, Japan
ISIS CLINICAL RESEARCH CENTER ( Site 0606)
Guaynabo, Puerto Rico
Klinical Investigations Group-Clinical Research ( Site 0601)
San Juan, Puerto Rico
Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 1004)
Santander, Cantabria, Spain
Hospital Clínico Universitario de Valladolid-Servicio de Endocrinologia y Nutricion ( Site 1008)
Valladolid, Castille and León, Spain
Hospital General de Tomelloso-Aparato Digestivo ( Site 1006)
Tomelloso, Ciudad Real, Spain
CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 1007)
A Coruña, La Coruna, Spain
CHUS - Hospital Clinico Universitario ( Site 1011)
Santiago de Compostela, La Coruna, Spain
Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 1002)
Barcelona, Spain
Hospital Universitario La Paz-HEPATOLOGIA ( Site 1005)
Madrid, Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos clinicos de Aparato Digestivo ( Site 1001)
Seville, Spain
Chulalongkorn University ( Site 1301)
Bangkok, Bangkok, Thailand
Faculty of Medicine Siriraj Hospital-Department of Medicine ( Site 1302)
Bangkok, Bangkok, Thailand
King's College Hospital ( Site 1104)
London, London, City of, United Kingdom
Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 1102)
Aberdeen, Scotland, United Kingdom