A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017)
NCT ID: NCT06465186
Last Updated: 2025-11-13
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
PHASE2
80 participants
INTERVENTIONAL
2024-07-12
2026-09-21
Brief Summary
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* 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
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Efinopegdutide
Participants will start efinopegdutide once a week at the lowest dose level. Then, the dose level will go up every month for three months until they are getting the highest dose level. Efinopegdutide is given as an injection under the skin (subcutaneous injection) for 28 weeks.
Efinopegdutide
Efinopegdutide is given as a subcutaneous injection using a single-use prefilled syringe, once per week for 28 weeks
Placebo
Participants will receive placebo once a week. A placebo looks like the study medicine but has no study medicine in it. Using a placebo helps researchers better understand the effects of a study medicine.
Placebo is given as an injection under the skin (subcutaneous injection) for 28 weeks.
Placebo
Placebo is given as a subcutaneous injection using a single-use prefilled syringe once per week for 28 weeks.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has either type 2 diabetes that is controlled by diet or medication, or does not have type 2 diabetes
Exclusion Criteria
* Has history of type 1 diabetes
* Had a bariatric surgical procedure less than 5 years before entry into the study
* History of pancreatitis
* Major illnesses like recent (within 6 months of study entry) episodes of heart problems, such as congestive heart failure, unstable angina, heart attack, stroke, or mini-stroke
18 Years
80 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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2024-510923-20-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
MK-6024-017
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031240217
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1302-7589
Identifier Type: REGISTRY
Identifier Source: secondary_id
6024-017
Identifier Type: -
Identifier Source: org_study_id