A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)
NCT ID: NCT05877547
Last Updated: 2026-01-12
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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COMPLETED
PHASE2
381 participants
INTERVENTIONAL
2023-06-23
2025-12-29
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
TRIPLE
Study Groups
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Efinopegdutide 4mg
Efinopegdutide administered by subcutaneous (SC) injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks and 4mg for 48 weeks.
Efinopegdutide
Subcutaneous (SC) injection in dose-escalation regimens potentially including doses of 2 mg, 4 mg, 7 mg, and 10 mg
Efinopegdutide 7mg
Efinopegdutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, and 7 mg for 44 weeks.
Efinopegdutide
Subcutaneous (SC) injection in dose-escalation regimens potentially including doses of 2 mg, 4 mg, 7 mg, and 10 mg
Efinopegdutide 10mg
Efinopegdutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for 40 weeks.
Efinopegdutide
Subcutaneous (SC) injection in dose-escalation regimens potentially including doses of 2 mg, 4 mg, 7 mg, and 10 mg
Placebo
Placebo administered by SC injection once weekly for 52 weeks
Placebo
SC injection of matching placebo
Semaglutide 2.4 mg
Semaglutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 0.25 mg for 4 weeks, 0.5 mg for 4 weeks, 1.0 mg for 4 weeks, 1.7 mg for 4 weeks, and 2.4 mg for 36 weeks.
Semaglutide
SC injection in a dose-escalation regimen of 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg
Interventions
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Efinopegdutide
Subcutaneous (SC) injection in dose-escalation regimens potentially including doses of 2 mg, 4 mg, 7 mg, and 10 mg
Semaglutide
SC injection in a dose-escalation regimen of 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg
Placebo
SC injection of matching placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM with an A1C ≤9% that is controlled by diet or stable doses of antihyperglycemic agents (AHAs)
* Participants in South Korea are eligible between the ages of 19 to 80 years of age (inclusive)
Exclusion Criteria
* History or evidence of cirrhosis
* History of pancreatitis
* History of Type 1 diabetes mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatectomy
* History of a bariatric surgical procedure ≤5 years before study entry, or a known clinically significant gastric emptying abnormality
* Has significant systemic or major illnesses, including recent events (≤6 months before study entry) of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack
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 3
Chandler, Arizona, United States
The Institute for Liver Health II dba Arizona Clinical Trials - Peoria ( Site 3289)
Peoria, Arizona, United States
The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 3218)
Tucson, Arizona, United States
Del Sol Research Management, LLC ( Site 3211)
Tucson, Arizona, United States
Om Research - Apple Valley ( Site 3244)
Apple Valley, California, United States
Om Research LLC ( Site 3245)
Camarillo, California, United States
Velocity Clinical Research, Gardena ( Site 3225)
Gardena, California, United States
Velocity Clinical Research, Huntington Park ( Site 3217)
Huntington Park, California, United States
Velocity Clinical Research, San Diego ( Site 3226)
La Mesa, California, United States
Om Research LLC ( Site 3229)
Lancaster, California, United States
Velocity Clinical Research, Westlake ( Site 3216)
Los Angeles, California, United States
Velocity Clinical Research, Panorama City ( Site 3214)
Panorama City, California, United States
California Liver Research Institute ( Site 3232)
Pasadena, California, United States
Clinical Trials Research ( Site 3230)
Sacramento, California, United States
Excel Medical Clinical Trials ( Site 3246)
Boca Raton, Florida, United States
Synergy Healthcare ( Site 3286)
Bradenton, Florida, United States
Synergy Healthcare LLC ( Site 3290)
Brandon, Florida, United States
Top Medical Research ( Site 3209)
Cutler Bay, Florida, United States
Covenant Metabolic Specialists, LLC ( Site 3231)
Fort Myers, Florida, United States
Velocity Clinical Research, Hallandale Beach ( Site 3241)
Hallandale, Florida, United States
Indago Research & Health Center, Inc ( Site 3207)
Hialeah, Florida, United States
Sweet Hope Research Specialty, Inc-Research ( Site 3200)
Hialeah, Florida, United States
Florida Research Institute ( Site 3243)
Lakewood Rch, Florida, United States
Genoma Research Group ( Site 3242)
Miami, Florida, United States
Floridian Clinical Research, LLC ( Site 3203)
Miami Lakes, Florida, United States
Southeast Clinical Research Center ( Site 3288)
Dalton, Georgia, United States
Eagle Clinical Research ( Site 3233)
Chicago, Illinois, United States
University of Iowa ( Site 3213)
Iowa City, Iowa, United States
Kansas City Research Institute ( Site 3249)
Kansas City, Missouri, United States
The Machuca Foundation ( Site 3234)
Las Vegas, Nevada, United States
Velocity Clinical Research, Syracuse ( Site 3227)
East Syracuse, New York, United States
New York Gastroenterology Associates ( Site 3252)
New York, New York, United States
Velocity Clinical Research, Cincinnati ( Site 3237)
Cincinnati, Ohio, United States
Velocity Clinical Research, Providence ( Site 3222)
East Greenwich, Rhode Island, United States
Velocity Clinical Research, Austin ( Site 3235)
Austin, Texas, United States
South Texas Research Institute - Brownsville ( Site 3285)
Brownsville, Texas, United States
Velocity Clinical Research, Dallas ( Site 3220)
Dallas, Texas, United States
Houston Research Institute ( Site 3262)
Houston, Texas, United States
American Research Corporation ( Site 3202)
San Antonio, Texas, United States
Pinnacle Clinical Research ( Site 3284)
San Antonio, Texas, United States
Velocity Clinical Research, Salt Lake City ( Site 3223)
West Jordan, Utah, United States
Gastroenterology Consultants of Southwest Virginia ( Site 3282)
Roanoke, Virginia, United States
Medizinische Universität Graz-Department of Internal Medicine ( Site 0302)
Graz, Styria, Austria
Antwerp University Hospital-Gastr-enterologie/hepatologie ( Site 3300)
Edegem, Antwerpen, Belgium
AZ Maria Middelares-Digestief Centrum ( Site 3301)
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven-Hepatology ( Site 3302)
Leuven, Vlaams-Brabant, Belgium
Heritage Medical Research Clinic ( Site 0403)
Calgary, Alberta, Canada
Vancouver General Hospital-Gastroenterology ( Site 0408)
Vancouver, British Columbia, Canada
Toronto General Hospital ( Site 0402)
Toronto, Ontario, Canada
McGill University Health Centre ( Site 0400)
Montreal, Quebec, Canada
Diex Recherche Quebec Inc. ( Site 0409)
Québec, Quebec, Canada
Enroll SpA ( Site 0501)
Providencia, Region M. de Santiago, Chile
CECIM ( Site 0500)
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile-CICUC ( Site 0502)
Santiago, Region M. de Santiago, Chile
Beijing Youan Hospital ( Site 0602)
Beijing, Beijing Municipality, China
Beijing Tsinghua Changgung Hospital ( Site 0606)
Beijing, Beijing Municipality, China
Chongqing University Three Gorges Hospital ( Site 0607)
Wanzhou, Chongqing Municipality, China
The First Affiliated Hospital, Sun Yat-sen University ( Site 0603)
Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital ( Site 0601)
Guangzhou, Guangdong, China
No. 2 Hospital of Nanjing ( Site 0605)
Nanjing, Jiangsu, China
West China Hospital, Sichuan University ( Site 0611)
Chengdu, Sichuan, China
Tianjin Second People's Hospital ( Site 0604)
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Wenzhou Medical University ( Site 0609)
Wenzhou, Zhejiang, China
Fundación Centro de Investigación Clínica CIC ( Site 0704)
Medellín, Antioquia, Colombia
Sociedad De Oncología y Hematología Del Cesar SAS ( Site 0708)
Valledupar, Cesar Department, Colombia
Fundacion Santa Fe de Bogota ( Site 0701)
Bogotá, Cundinamarca, Colombia
Solano & Terront Servicios Medicos - UNIENDO ( Site 0705)
Bogotá, Cundinamarca, Colombia
Oncomédica S.A.S ( Site 0702)
Montería, Departamento de Córdoba, Colombia
Fundación Valle del Lili ( Site 0700)
Cali, Valle del Cauca Department, Colombia
KlinMed ( Site 0801)
Prague, Praha 2, Czechia
Krajská nemocnice Liberec ( Site 0800)
Liberec, , Czechia
Vseobecna fakultni nemocnice v Praze ( Site 0802)
Prague, , Czechia
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Pôle de Référence Hépato Gastro-entérol
Nice, Alpes-Maritimes, France
CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0904)
Pessac, Aquitaine, France
Hôpital de la Croix Rousse-Centre de Recherche Clinique ( Site 0911)
Lyon, Auvergne-Rhône-Alpes, France
centre hospitalier lyon sud-Endocrinologie, Diabète et Nutrition ( Site 0906)
Pierre-Bénite, Auvergne-Rhône-Alpes, France
CHU Charles Nicolle ( Site 0910)
Rouen, Haute-Normandie, France
Hôpital Beaujon-Hépatologie ( Site 0908)
Clichy, Hauts-de-Seine, France
Centre Hospitalier Universitaire d'Angers-Hepato Gastroenterology ( Site 0900)
Angers, Maine-et-Loire, France
Centre Hospitalier Universitaire Estaing ( Site 0913)
Clermont-Ferrand, Puy-de-Dome, France
Hôpital Saint Antoine ( Site 0914)
Paris, , France
Hopitaux Universitaires Paris Centre-Hopital Cochin-Service HEPATOLOGIE- Recherche Clinique ( Site 0
Paris, , France
Prince of Wales Hospital ( Site 1000)
Shatin, , Hong Kong
SYNEXUS Magyarország Kft. Eü. ( Site 1110)
Budapest, , Hungary
Dél-Pesti Centrumkórház-Hepatologiai Szakrendekő ( Site 1102)
Budapest, , Hungary
Barzilai Medical Center ( Site 1306)
Ashkelon, , Israel
Rambam Health Care Campus ( Site 1304)
Haifa, , Israel
Carmel Hospital ( Site 1305)
Haifa, , Israel
Shaare Zedek Medical Center-Liver Unit ( Site 1302)
Jerusalem, , Israel
Rabin Medical Center ( Site 1301)
Petah Tikva, , Israel
Sheba Medical Center ( Site 1300)
Ramat Gan, , Israel
Maccabi Health Services - Ramat Hasharon ( Site 1303)
Ramat HaSharon, , Israel
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Dipartimento di Medicina Interna e Gas
Rome, Lazio, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 1403)
Milan, Lombardy, Italy
Humanitas-Medicina interna ed Epatologia ( Site 1400)
Rozzano, Lombardy, Italy
A.O.U. Policlinico Paolo Giaccone-Dep. Of Internal Medicine and Specialistic ( Site 1402)
Palermo, Sicily, Italy
Azienda Ospedaliero-Universitaria Città della Salute e della-S.C. Gastroenterologia U. ( Site 1401)
Torino, , Italy
Ehime University Hospital ( Site 1509)
Tōon, Ehime, Japan
Kurume University Hospital ( Site 1504)
Kurume, Fukuoka, Japan
Ogaki Municipal Hospital ( Site 1511)
Ōgaki, Gifu, Japan
Sapporo Kosei General Hospital ( Site 1521)
Sapporo, Hokkaido, Japan
Kagawa University Hospital ( Site 1515)
Kita, Kagawa-ken, Japan
Kagawa Prefectural Central Hospital ( Site 1514)
Takamatsu, Kagawa-ken, Japan
Toranomon Hospital Kajigaya ( Site 1502)
Kawasaki, Kanagawa, Japan
Shinyurigaoka General Hospital ( Site 1518)
Kawasaki, Kanagawa, Japan
St. Marianna University Hospital ( Site 1516)
Kawasaki, Kanagawa, Japan
Yokohama City University Hospital ( Site 1505)
Yokohama, Kanagawa, Japan
Shinshu University Hospital ( Site 1512)
Matsumoto, Nagano, Japan
Nara Medical University Hospital ( Site 1513)
Kashihara, Nara, Japan
Osaka Saiseikai Suita Hospital ( Site 1503)
Suita, Osaka, Japan
Toranomon Hospital ( Site 1501)
Minato-ku, Tokyo, Japan
Fukuiken Saiseikai Hospital ( Site 1507)
Fukui, , Japan
Gifu Municipal Hospital ( Site 1506)
Gifu, , Japan
University Hospital,Kyoto Prefectural University of Medicine ( Site 1519)
Kyoto, , Japan
Kawasaki Medical School General Medical Center ( Site 1508)
Okayama, , Japan
Osaka Metropolitan University Hospital ( Site 1520)
Osaka, , Japan
Saga University Hospital ( Site 1510)
Saga, , Japan
Japanese Red Cross Musashino Hospital ( Site 1517)
Tokyo, , Japan
Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 1603)
Mexico City, Mexico City, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 1604)
Monterrey, Nuevo León, Mexico
Servicios de Oncología Médica Integral - Monterrey ( Site 1611)
Monterrey, Nuevo León, Mexico
ICARO Investigaciones en Medicina ( Site 1608)
Chihuahua City, , Mexico
Centro de Investigación y Gastroenterología ( Site 1601)
Cuauhtémoc, , Mexico
Centro de Investigación y Gastroenterología - S.C. ( Site 1609)
Mexico City, , Mexico
Oaxaca Site Management Organization ( Site 1613)
Oaxaca City, , Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 1607)
Oaxaca City, , Mexico
Centro de investigacion Clínica Trujillo ( Site 1802)
Trujillo, La Libertad, Peru
CLINICA DELGADO-Clinical Research ( Site 1800)
Miraflores, Lima region, Peru
Instituto Médico Soy Diabetico ( Site 1804)
Piura, , Peru
Unidade Local de Saúde do Alto Ave - Hospital Senhora da Oliveira ( Site 1905)
Guimarães, Braga District, Portugal
Unidade Local de Saude Lisboa Ocidental - Hospital Egas Moniz ( Site 1906)
Lisbon, Lisbon District, Portugal
Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1904)
Lisbon, Lisbon District, Portugal
ULSAM - Hospital de Santa Luzia ( Site 1907)
Viana do Castelo, , Portugal
ISIS CLINICAL RESEARCH CENTER ( Site 2006)
Guaynabo, , Puerto Rico
Pan American Center for Oncology Trials ( Site 2000)
Rio Piedras, , Puerto Rico
Klinical Investigations Group-Clinical Research ( Site 2001)
San Juan, , Puerto Rico
Latin Clinical Trial Center ( Site 2004)
San Juan, , Puerto Rico
Singapore General Hospital ( Site 2188)
Singapore, Central Singapore, Singapore
Boramae Medical Center-Internal Medicine ( Site 2403)
Dongjak-gu, Seoul, South Korea
Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2402)
Incheon, , South Korea
Severance Hospital, Yonsei University Health System ( Site 2401)
Seoul, , South Korea
Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 2400)
Seoul, , South Korea
Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 2506)
Málaga, Andalusia, Spain
Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 2505)
Santander, Cantabria, Spain
Hospital General de Tomelloso-Aparato Digestivo ( Site 2514)
Tomelloso, Ciudad Real, Spain
CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 2511)
A Coruña, La Coruna, Spain
CHUS - Hospital Clinico Universitario ( Site 2503)
Santiago de Compostela, La Coruna, Spain
Hospital Universitario Ramón y Cajal ( Site 2508)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 2507)
Barcelona, , Spain
Hospital Universitario La Paz-HEPATOLOGIA ( Site 2509)
Madrid, , Spain
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Gastroenterologia y Hepatologia ( Site 2500)
Madrid, , Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos Clínicos de Aparato Digestivo ( Site 2504)
Seville, , Spain
Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 2601)
Sankt Gallen, Canton of St. Gallen, Switzerland
UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 2603)
Zurich, Canton of Zurich, Switzerland
Fondazione Epatocentro Ticino ( Site 2602)
Lugano, Canton Ticino, Switzerland
Changhua Christian Hospital-Endocrinology and metabolism ( Site 2704)
Changhua County, Changhua, Taiwan
Chiayi Christian Hospital ( Site 2707)
Chiayi City, Chiayi, Taiwan
Taichung Veterans General Hospital ( Site 2703)
Taichung, , Taiwan
National Cheng Kung University Hospital-Liver Research team of National Cheng Kung University Hospi
Tainan, , Taiwan
National Taiwan University Hospital-Internal Medicine ( Site 2700)
Taipei, , Taiwan
Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine (
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 2702)
Taoyuan District, , Taiwan
Chulalongkorn University ( Site 2800)
Bangkok, Bangkok, Thailand
Faculty of Medicine Siriraj Hospital-Department of Medicine ( Site 2802)
Bangkok, Bangkok, Thailand
Maharaj Nakorn Chiang Mai Hospital ( Site 2801)
Muang, Chiang Mai, Thailand
Hacettepe Universite Hastaneleri-internal diseases ( Site 2901)
Ankara, , Turkey (Türkiye)
Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 2903)
Istanbul, , Turkey (Türkiye)
T.C. Sağlik Bakanliği- Marmara Üniversitesi İstanbul Pendik -T.C. Sağlik Bakanliği- Marmara Ünivers
Istanbul, , Turkey (Türkiye)
Dokuz Eylul Universitesi Hastanesi-Gastroenterology ( Site 2905)
Izmir, , Turkey (Türkiye)
Recep Tayyip Erdogan University Training and Research Hospital ( Site 2900)
Rize, , Turkey (Türkiye)
Royal London Hospital ( Site 3003)
London, England, United Kingdom
King's College Hospital ( Site 3002)
London, London, City of, United Kingdom
Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 3004)
Aberdeen, Scotland, United Kingdom
Queen Elizabeth Hospital Birmingham ( Site 3000)
Birmingham, Warwickshire, United Kingdom
St James's University Hospital ( Site 3005)
Leeds, , 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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2022-502647-35-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
MK-6024-013
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031230187
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1285-0933
Identifier Type: REGISTRY
Identifier Source: secondary_id
6024-013
Identifier Type: -
Identifier Source: org_study_id
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