A Clinical Study of Efinopegdutide in People With Compensated Cirrhosis Due to Steatohepatitis (MK-6024-017)

Last updated: May 14, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Primary Biliary Cholangitis

Liver Disease

Treatment

Placebo

Efinopegdutide

Clinical Study ID

NCT06465186
6024-017
MK-6024-017
jRCT2031240217
U1111-1302-7589
2024-510923-20
2024-510923-20-00
  • Ages 18-80
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

  • Has compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH)

  • Has either type 2 diabetes that is controlled by diet or medication, or does nothave type 2 diabetes

Exclusion

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • Has history of a liver disease other than MASH, for example, Hepatitis B or C,drug-induced liver disease, or autoimmune liver disease

  • 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 heartproblems, such as congestive heart failure, unstable angina, heart attack, stroke,or mini-stroke

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
July 12, 2024
Estimated Completion Date:
May 15, 2026

Connect with a study center

  • Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 1202)

    Adelaide, South Australia 5042
    Australia

    Active - Recruiting

  • St Vincent's Hospital-Gastroenterology Department ( Site 1205)

    Melbourne, Victoria 3065
    Australia

    Active - Recruiting

  • Toronto General Hospital ( Site 0207)

    Toronto, Ontario M5G 2C4
    Canada

    Active - Recruiting

  • Diex Recherche Quebec ( Site 0204)

    Quebec, G1V 4T3
    Canada

    Active - Recruiting

  • Diex Recherche Quebec Inc. ( Site 0204)

    Quebec, G1V 4T3
    Canada

    Active - Recruiting

  • Fundacion Santa Fe de Bogota ( Site 0403)

    Bogotá, Cundinamarca 110111
    Colombia

    Active - Recruiting

  • Fundación Valle del Lili ( Site 0402)

    Cali, Valle Del Cauca 760032
    Colombia

    Active - Recruiting

  • CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0701)

    Pessac, Aquitaine 33600
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-Hépato-gastroentérologie ( Site 0702

    Limoges, Limousin 87042
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren-Hépato-gastroentérologie ( Site 0702)

    Limoges, Limousin 87042
    France

    Active - Recruiting

  • Hôpital de la Croix Rousse-Centre de Recherche Clinique ( Site 0705)

    Lyon, Rhone-Alpes 69004
    France

    Active - Recruiting

  • Carmel Hospital-Liver Unit ( Site 0802)

    Haifa, 3436212
    Israel

    Active - Recruiting

  • Rambam Health Care Campus ( Site 0801)

    Haifa, 3109601
    Israel

    Active - Recruiting

  • Shaare Zedek Medical Center ( Site 0805)

    Jerusalem, 9103102
    Israel

    Active - Recruiting

  • Maccabi Health Services - Petah Tikva ( Site 0804)

    Petah Tikva, 4925110
    Israel

    Active - Recruiting

  • Shinyurigaoka General Hospital ( Site 1401)

    Kawasaki, Kanagawa 215-0026
    Japan

    Active - Recruiting

  • Yokohama City University Hospital ( Site 1402)

    Yokohama, Kanagawa 236-0004
    Japan

    Active - Recruiting

  • University Hospital,Kyoto Prefectural University of Medicine ( Site 1404)

    Kyoto, 602-8566
    Japan

    Active - Recruiting

  • Osaka Metropolitan University Hospital ( Site 1403)

    Osaka, 545-8586
    Japan

    Active - Recruiting

  • Saga University Hospital ( Site 1405)

    Saga, 849-8501
    Japan

    Active - Recruiting

  • ISIS CLINICAL RESEARCH CENTER ( Site 0606)

    Guaynabo, 00968
    Puerto Rico

    Active - Recruiting

  • Klinical Investigations Group-Clinical Research ( Site 0601)

    San Juan, 00909
    Puerto Rico

    Active - Recruiting

  • Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 1004)

    Santander, Cantabria 39005
    Spain

    Active - Recruiting

  • Hospital Clínico Universitario de Valladolid-Servicio de Endocrinologia y Nutricion ( Site 1008)

    Valladolid, Castilla Y Leon 47010
    Spain

    Active - Recruiting

  • Hospital General de Tomelloso-Aparato Digestivo ( Site 1006)

    Tomelloso, Ciudad Real 13700
    Spain

    Active - Recruiting

  • CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 1007)

    A Coruña, La Coruna 15006
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 1002)

    Barcelona, 08035
    Spain

    Active - Recruiting

  • Hospital Universitario La Paz-HEPATOLOGIA ( Site 1005)

    Madrid, 28046
    Spain

    Active - Recruiting

  • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos clinicos de Aparato Digestivo ( Site 1001)

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Chulalongkorn University ( Site 1301)

    Bangkok, Krung Thep Maha Nakhon 10330
    Thailand

    Active - Recruiting

  • Faculty of Medicine Siriraj Hospital-Department of Medicine ( Site 1302)

    Bangkok, Krung Thep Maha Nakhon 10700
    Thailand

    Active - Recruiting

  • King's College Hospital ( Site 1104)

    London, London, City Of SE5 9RL
    United Kingdom

    Active - Recruiting

  • Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 1102)

    Aberdeen, Scotland AB25 2ZN
    United Kingdom

    Active - Recruiting

  • The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0

    Chandler, Arizona 85224
    United States

    Active - Recruiting

  • The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 0149)

    Chandler, Arizona 85224
    United States

    Active - Recruiting

  • Arizona Clinical Trials ( Site 0158)

    Flagstaff, Arizona 86001
    United States

    Active - Recruiting

  • The Institute for Liver Health II dba Arizona Liver Health - Peoria ( Site 0120)

    Peoria, Arizona 85381
    United States

    Active - Recruiting

  • The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 0111)

    Tucson, Arizona 85712
    United States

    Active - Recruiting

  • California Liver Research Institute ( Site 0113)

    Pasadena, California 91105
    United States

    Active - Recruiting

  • Acclaim Clinical Research ( Site 0137)

    San Diego, California 92120
    United States

    Active - Recruiting

  • Velocity Clinical Research, Panorama City ( Site 0124)

    Van Nuys, California 91405
    United States

    Active - Recruiting

  • Rocky Mountain Gastroenterology ( Site 0127)

    Littleton, Colorado 80120
    United States

    Active - Recruiting

  • Synergy Healthcare ( Site 0118)

    Bradenton, Florida 34209
    United States

    Active - Recruiting

  • Homestead Associates in Research, Inc. ( Site 0139)

    Homestead, Florida 33033
    United States

    Active - Recruiting

  • Florida Research Institute ( Site 0116)

    Lakewood Ranch, Florida 34211
    United States

    Active - Recruiting

  • Floridian Clinical Research, LLC ( Site 0109)

    Miami Lakes, Florida 33016
    United States

    Active - Recruiting

  • Southeast Clinical Research Center ( Site 0119)

    Dalton, Georgia 30720
    United States

    Active - Recruiting

  • Delta Research Partners ( Site 0160)

    Bastrop, Louisiana 71220
    United States

    Active - Recruiting

  • Louisiana Research Center ( Site 0161)

    Shreveport, Louisiana 71105
    United States

    Active - Recruiting

  • Woodholme Gastroenterology Associates-Woodholme Gastroenterology Associates ( Site 0130)

    Glen Burnie, Maryland 21061
    United States

    Active - Recruiting

  • Velocity Clinical Research Rockville ( Site 0143)

    Rockville, Maryland 20854
    United States

    Active - Recruiting

  • Huron Gastroenterology ( Site 0102)

    Ypsilanti, Michigan 48197
    United States

    Active - Recruiting

  • Excel Clinical Research, LLC ( Site 0101)

    Las Vegas, Nevada 89109
    United States

    Active - Recruiting

  • The Machuca Foundation ( Site 0115)

    Las Vegas, Nevada 89101
    United States

    Active - Recruiting

  • Southwest Gastroenterology Associates ( Site 0129)

    Albuquerque, New Mexico 87109
    United States

    Active - Recruiting

  • Coastal Research Institute - Fayetteville ( Site 0159)

    Fayetteville, North Carolina 28304
    United States

    Active - Recruiting

  • Lucas Research, Inc ( Site 0105)

    Morehead City, North Carolina 28557
    United States

    Active - Recruiting

  • Texas Clinical Research Institute ( Site 0126)

    Arlington, Texas 76012
    United States

    Active - Recruiting

  • Pinnacle Clinical Research ( Site 0104)

    Austin, Texas 78757
    United States

    Active - Recruiting

  • Pinnacle Clinical Research-Corpus Christi ( Site 0156)

    Corpus Christi, Texas 78404
    United States

    Active - Recruiting

  • Zenos Clinical Research ( Site 0136)

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • GI Alliance Department of Research ( Site 0162)

    Fort Worth, Texas 76104
    United States

    Active - Recruiting

  • Houston Research Institute ( Site 0117)

    Houston, Texas 77079
    United States

    Active - Recruiting

  • American Research Corporation ( Site 0131)

    San Antonio, Texas 78215
    United States

    Active - Recruiting

  • Pinnacle Clinical Research-Clinical Research Coordination ( Site 0125)

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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