A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)

A Phase 2b Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Efinopegdutide (MK-6024) in Adults With Precirrhotic Nonalcoholic Steatohepatitis

The purpose of this study is to learn how well efinopegdutide works compared to placebo in people who have non-alcoholic steatohepatitis (NASH). Researchers will also learn about the safety and benefit of efinopegdutide and how well people tolerate the medicine. The main goal of the study is to compare how many people taking efinopegdutide or placebo stop showing evidence of NASH without liver scarring getting worse.

Study Overview

• Status: Completed
• Conditions: Non-alcoholic Fatty Liver Disease; NAFLD; Nonalcoholic Fatty Liver Disease; Nonalcoholic Steatohepatitis; Fatty Liver, Nonalcoholic
• Intervention / Treatment: Drug: Efinopegdutide; Drug: Placebo; Drug: Semaglutide

• Study Type: Interventional
• Enrollment (Actual): 381
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Styria
    • Graz, Styria, Austria, 8036
      • Medizinische Universität Graz-Department of Internal Medicine ( Site 0302)
• Belgium
  • Antwerpen
    • Edegem, Antwerpen, Belgium, 2650
      • Antwerp University Hospital-Gastr-enterologie/hepatologie ( Site 3300)
  • Oost-Vlaanderen
    • Ghent, Oost-Vlaanderen, Belgium, 9000
      • AZ Maria Middelares-Digestief Centrum ( Site 3301)
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3001
      • UZ Leuven-Hepatology ( Site 3302)
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4Z6
      • Heritage Medical Research Clinic ( Site 0403)
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver General Hospital-Gastroenterology ( Site 0408)
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • Toronto General Hospital ( Site 0402)
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre ( Site 0400)
    • Québec, Quebec, Canada, G1V 4T3
      • Diex Recherche Quebec Inc. ( Site 0409)
• Chile
  • Region M. de Santiago
    • Providencia, Region M. de Santiago, Chile, 7500587
      • Enroll SpA ( Site 0501)
    • Santiago, Region M. de Santiago, Chile, 8320000
      • CECIM ( Site 0500)
    • Santiago, Region M. de Santiago, Chile, 8330032
      • Pontificia Universidad Catolica de Chile-CICUC ( Site 0502)
• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100069
      • Beijing Youan Hospital ( Site 0602)
    • Beijing, Beijing Municipality, China, 102218
      • Beijing Tsinghua Changgung Hospital ( Site 0606)
  • Chongqing Municipality
    • Wanzhou, Chongqing Municipality, China, 404000
      • Chongqing University Three Gorges Hospital ( Site 0607)
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • The First Affiliated Hospital, Sun Yat-sen University ( Site 0603)
    • Guangzhou, Guangdong, China, 510515
      • Southern Medical University Nanfang Hospital ( Site 0601)
  • Jiangsu
    • Nanjing, Jiangsu, China, 210037
      • No. 2 Hospital of Nanjing ( Site 0605)
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University ( Site 0611)
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300192
      • Tianjin Second People's Hospital ( Site 0604)
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325000
      • The First Affiliated Hospital of Wenzhou Medical University ( Site 0609)
• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia, 050021
      • Fundación Centro de Investigación Clínica CIC ( Site 0704)
  • Cesar Department
    • Valledupar, Cesar Department, Colombia, 200001
      • Sociedad De Oncología y Hematología Del Cesar SAS ( Site 0708)
  • Cundinamarca
    • Bogotá, Cundinamarca, Colombia, 110111
      • Fundacion Santa Fe de Bogota ( Site 0701)
    • Bogotá, Cundinamarca, Colombia, 110221
      • Solano & Terront Servicios Medicos - UNIENDO ( Site 0705)
  • Departamento de Córdoba
    • Montería, Departamento de Córdoba, Colombia, 230002
      • Oncomédica S.A.S ( Site 0702)
  • Valle del Cauca Department
    • Cali, Valle del Cauca Department, Colombia, 760026
      • Fundación Valle del Lili ( Site 0700)
• Czechia
  • Liberec, Czechia, 460 63
    • Krajská nemocnice Liberec ( Site 0800)
  • Prague, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze ( Site 0802)
  • Praha 2
    • Prague, Praha 2, Czechia, 120 00
      • KlinMed ( Site 0801)
• France
  • Paris, France, 75571
    • Hôpital Saint Antoine ( Site 0914)
  • Paris, France, 75679
    • Hopitaux Universitaires Paris Centre-Hopital Cochin-Service HEPATOLOGIE- Recherche Clinique ( Site 0
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06202
      • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Pôle de Référence Hépato Gastro-entérol
  • Aquitaine
    • Pessac, Aquitaine, France, 33600
      • CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0904)
  • Auvergne-Rhône-Alpes
    • Lyon, Auvergne-Rhône-Alpes, France, 69004
      • Hôpital de la Croix Rousse-Centre de Recherche Clinique ( Site 0911)
    • Pierre-Bénite, Auvergne-Rhône-Alpes, France, 69494 Cédex
      • centre hospitalier lyon sud-Endocrinologie, Diabète et Nutrition ( Site 0906)
  • Haute-Normandie
    • Rouen, Haute-Normandie, France, 76000
      • CHU Charles Nicolle ( Site 0910)
  • Hauts-de-Seine
    • Clichy, Hauts-de-Seine, France, 92110
      • Hôpital Beaujon-Hépatologie ( Site 0908)
  • Maine-et-Loire
    • Angers, Maine-et-Loire, France, 49933
      • Centre Hospitalier Universitaire d'Angers-Hepato Gastroenterology ( Site 0900)
  • Puy-de-Dome
    • Clermont-Ferrand, Puy-de-Dome, France, 63100
      • Centre Hospitalier Universitaire Estaing ( Site 0913)
• Hong Kong
  • Shatin, Hong Kong
    • Prince of Wales Hospital ( Site 1000)
• Hungary
  • Budapest, Hungary, 1036
    • SYNEXUS Magyarország Kft. Eü. ( Site 1110)
  • Budapest, Hungary, 1097
    • Dél-Pesti Centrumkórház-Hepatologiai Szakrendekő ( Site 1102)
• Israel
  • Ashkelon, Israel, 7830604
    • Barzilai Medical Center ( Site 1306)
  • Haifa, Israel, 3109601
    • Rambam Health Care Campus ( Site 1304)
  • Haifa, Israel, 3436212
    • Carmel Hospital ( Site 1305)
  • Jerusalem, Israel, 9778419
    • Shaare Zedek Medical Center-Liver Unit ( Site 1302)
  • Petah Tikva, Israel, 4941 492
    • Rabin Medical Center ( Site 1301)
  • Ramat Gan, Israel, 5265601
    • Sheba Medical Center ( Site 1300)
  • Ramat HaSharon, Israel, 4731001
    • Maccabi Health Services - Ramat Hasharon ( Site 1303)
• Italy
  • Torino, Italy, 10126
    • Azienda Ospedaliero-Universitaria Città della Salute e della-S.C. Gastroenterologia U. ( Site 1401)
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Dipartimento di Medicina Interna e Gas
  • Lombardy
    • Milan, Lombardy, Italy, 20122
      • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 1403)
    • Rozzano, Lombardy, Italy, 20089
      • Humanitas-Medicina interna ed Epatologia ( Site 1400)
  • Sicily
    • Palermo, Sicily, Italy, 90127
      • A.O.U. Policlinico Paolo Giaccone-Dep. Of Internal Medicine and Specialistic ( Site 1402)
• Japan
  • Fukui, Japan, 918-8503
    • Fukuiken Saiseikai Hospital ( Site 1507)
  • Gifu, Japan, 500-8513
    • Gifu Municipal Hospital ( Site 1506)
  • Kyoto, Japan, 602-8566
    • University Hospital,Kyoto Prefectural University of Medicine ( Site 1519)
  • Okayama, Japan, 700-8505
    • Kawasaki Medical School General Medical Center ( Site 1508)
  • Osaka, Japan, 545-8586
    • Osaka Metropolitan University Hospital ( Site 1520)
  • Saga, Japan, 849-8501
    • Saga University Hospital ( Site 1510)
  • Tokyo, Japan, 180-8610
    • Japanese Red Cross Musashino Hospital ( Site 1517)
  • Ehime
    • Tōon, Ehime, Japan, 7910295
      • Ehime University Hospital ( Site 1509)
  • Fukuoka
    • Kurume, Fukuoka, Japan, 830-0011
      • Kurume University Hospital ( Site 1504)
  • Gifu
    • Ōgaki, Gifu, Japan, 503-0864
      • Ogaki Municipal Hospital ( Site 1511)
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-0033
      • Sapporo Kosei General Hospital ( Site 1521)
  • Kagawa-ken
    • Kita, Kagawa-ken, Japan, 761-0701
      • Kagawa University Hospital ( Site 1515)
    • Takamatsu, Kagawa-ken, Japan, 760-8557
      • Kagawa Prefectural Central Hospital ( Site 1514)
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 105-8470
      • Toranomon Hospital Kajigaya ( Site 1502)
    • Kawasaki, Kanagawa, Japan, 215-0026
      • Shinyurigaoka General Hospital ( Site 1518)
    • Kawasaki, Kanagawa, Japan, 216-8511
      • St. Marianna University Hospital ( Site 1516)
    • Yokohama, Kanagawa, Japan, 236-0004
      • Yokohama City University Hospital ( Site 1505)
  • Nagano
    • Matsumoto, Nagano, Japan, 390-8621
      • Shinshu University Hospital ( Site 1512)
  • Nara
    • Kashihara, Nara, Japan, 634-0813
      • Nara Medical University Hospital ( Site 1513)
  • Osaka
    • Suita, Osaka, Japan, 564-0013
      • Osaka Saiseikai Suita Hospital ( Site 1503)
  • Tokyo
    • Minato-ku, Tokyo, Japan, 105-8470
      • Toranomon Hospital ( Site 1501)
• Mexico
  • Chihuahua City, Mexico, 31000
    • ICARO Investigaciones en Medicina ( Site 1608)
  • Cuauhtémoc, Mexico, 06700
    • Centro de Investigación y Gastroenterología ( Site 1601)
  • Mexico City, Mexico, 03330
    • Centro de Investigación y Gastroenterología - S.C. ( Site 1609)
  • Oaxaca City, Mexico, 68000
    • Oaxaca Site Management Organization ( Site 1613)
  • Oaxaca City, Mexico, 68020
    • Centro de Investigacion Clinica de Oaxaca ( Site 1607)
  • Mexico City
    • Mexico City, Mexico City, Mexico, 14050
      • Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 1603)
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 1604)
    • Monterrey, Nuevo León, Mexico, 66220
      • Servicios de Oncología Médica Integral - Monterrey ( Site 1611)
• Peru
  • Piura, Peru, 20009
    • Instituto Médico Soy Diabetico ( Site 1804)
  • La Libertad
    • Trujillo, La Libertad, Peru, 13001
      • Centro de investigacion Clínica Trujillo ( Site 1802)
  • Lima region
    • Miraflores, Lima region, Peru, 15074
      • CLINICA DELGADO-Clinical Research ( Site 1800)
• Portugal
  • Viana do Castelo, Portugal, 4904 - 858
    • ULSAM - Hospital de Santa Luzia ( Site 1907)
  • Braga District
    • Guimarães, Braga District, Portugal, 4835-044
      • Unidade Local de Saúde do Alto Ave - Hospital Senhora da Oliveira ( Site 1905)
  • Lisbon District
    • Lisbon, Lisbon District, Portugal, 1349-019
      • Unidade Local de Saude Lisboa Ocidental - Hospital Egas Moniz ( Site 1906)
    • Lisbon, Lisbon District, Portugal, 1649-035
      • Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1904)
• Puerto Rico
  • Guaynabo, Puerto Rico, 00968
    • ISIS CLINICAL RESEARCH CENTER ( Site 2006)
  • Rio Piedras, Puerto Rico, 00935
    • Pan American Center for Oncology Trials ( Site 2000)
  • San Juan, Puerto Rico, 00909
    • Klinical Investigations Group-Clinical Research ( Site 2001)
  • San Juan, Puerto Rico, 00909
    • Latin Clinical Trial Center ( Site 2004)
• Singapore
  • Central Singapore
    • Singapore, Central Singapore, Singapore, 169608
      • Singapore General Hospital ( Site 2188)
• South Korea
  • Incheon, South Korea, 22332
    • Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2402)
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System ( Site 2401)
  • Seoul, South Korea, 06351
    • Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 2400)
  • Seoul
    • Dongjak-gu, Seoul, South Korea, 07061
      • Boramae Medical Center-Internal Medicine ( Site 2403)
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 2507)
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz-HEPATOLOGIA ( Site 2509)
  • Madrid, Spain, 28222
    • HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Gastroenterologia y Hepatologia ( Site 2500)
  • Seville, Spain, 41013
    • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos Clínicos de Aparato Digestivo ( Site 2504)
  • Andalusia
    • Málaga, Andalusia, Spain, 29010
      • Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 2506)
  • Cantabria
    • Santander, Cantabria, Spain, 39005
      • Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 2505)
  • Ciudad Real
    • Tomelloso, Ciudad Real, Spain, 13700
      • Hospital General de Tomelloso-Aparato Digestivo ( Site 2514)
  • La Coruna
    • A Coruña, La Coruna, Spain, 15006
      • CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 2511)
    • Santiago de Compostela, La Coruna, Spain, 15706
      • CHUS - Hospital Clinico Universitario ( Site 2503)
  • Madrid, Comunidad de
    • Madrid, Madrid, Comunidad de, Spain, 28034
      • Hospital Universitario Ramón y Cajal ( Site 2508)
• Switzerland
  • Canton Ticino
    • Lugano, Canton Ticino, Switzerland, 6900
      • Fondazione Epatocentro Ticino ( Site 2602)
  • Canton of St. Gallen
    • Sankt Gallen, Canton of St. Gallen, Switzerland, 9007
      • Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 2601)
  • Canton of Zurich
    • Zurich, Canton of Zurich, Switzerland, 8091
      • UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 2603)
• Taiwan
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital ( Site 2703)
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital-Liver Research team of National Cheng Kung University Hospi
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital-Internal Medicine ( Site 2700)
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine (
  • Taoyuan District, Taiwan, 33305
    • Chang Gung Medical Foundation-Linkou Branch ( Site 2702)
  • Changhua
    • Changhua County, Changhua, Taiwan, 50006
      • Changhua Christian Hospital-Endocrinology and metabolism ( Site 2704)
  • Chiayi
    • Chiayi City, Chiayi, Taiwan, 600
      • Chiayi Christian Hospital ( Site 2707)
• Thailand
  • Bangkok
    • Bangkok, Bangkok, Thailand, 10330
      • Chulalongkorn University ( Site 2800)
    • Bangkok, Bangkok, Thailand, 10700
      • Faculty of Medicine Siriraj Hospital-Department of Medicine ( Site 2802)
  • Chiang Mai
    • Muang, Chiang Mai, Thailand, 50200
      • Maharaj Nakorn Chiang Mai Hospital ( Site 2801)
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06230
    • Hacettepe Universite Hastaneleri-internal diseases ( Site 2901)
  • Istanbul, Turkey (Türkiye), 34093
    • Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 2903)
  • Istanbul, Turkey (Türkiye), 34899
    • T.C. Sağlik Bakanliği- Marmara Üniversitesi İstanbul Pendik -T.C. Sağlik Bakanliği- Marmara Ünivers
  • Izmir, Turkey (Türkiye), 35340
    • Dokuz Eylul Universitesi Hastanesi-Gastroenterology ( Site 2905)
  • Rize, Turkey (Türkiye), 53100
    • Recep Tayyip Erdogan University Training and Research Hospital ( Site 2900)
• United Kingdom
  • Leeds, United Kingdom, LS9 7TF
    • St James's University Hospital ( Site 3005)
  • England
    • London, England, United Kingdom, E1 1BB
      • Royal London Hospital ( Site 3003)
  • London, City of
    • London, London, City of, United Kingdom, SE5 9RL
      • King's College Hospital ( Site 3002)
  • Scotland
    • Aberdeen, Scotland, United Kingdom, AB25 2ZN
      • Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 3004)
  • Warwickshire
    • Birmingham, Warwickshire, United Kingdom, B15 2TH
      • Queen Elizabeth Hospital Birmingham ( Site 3000)
• United States
  • Arizona
    • Chandler, Arizona, United States, 85224
      • The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 3
    • Peoria, Arizona, United States, 85381
      • The Institute for Liver Health II dba Arizona Clinical Trials - Peoria ( Site 3289)
    • Tucson, Arizona, United States, 85712
      • The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 3218)
    • Tucson, Arizona, United States, 85715
      • Del Sol Research Management, LLC ( Site 3211)
  • California
    • Apple Valley, California, United States, 92307
      • Om Research - Apple Valley ( Site 3244)
    • Camarillo, California, United States, 93012
      • Om Research LLC ( Site 3245)
    • Gardena, California, United States, 90247
      • Velocity Clinical Research, Gardena ( Site 3225)
    • Huntington Park, California, United States, 90255
      • Velocity Clinical Research, Huntington Park ( Site 3217)
    • La Mesa, California, United States, 91942
      • Velocity Clinical Research, San Diego ( Site 3226)
    • Lancaster, California, United States, 93534
      • Om Research LLC ( Site 3229)
    • Los Angeles, California, United States, 90057
      • Velocity Clinical Research, Westlake ( Site 3216)
    • Panorama City, California, United States, 91402
      • Velocity Clinical Research, Panorama City ( Site 3214)
    • Pasadena, California, United States, 91105
      • California Liver Research Institute ( Site 3232)
    • Sacramento, California, United States, 95821
      • Clinical Trials Research ( Site 3230)
  • Florida
    • Boca Raton, Florida, United States, 33434
      • Excel Medical Clinical Trials ( Site 3246)
    • Bradenton, Florida, United States, 34208
      • Synergy Healthcare ( Site 3286)
    • Brandon, Florida, United States, 33511
      • Synergy Healthcare LLC ( Site 3290)
    • Cutler Bay, Florida, United States, 33189
      • Top Medical Research ( Site 3209)
    • Fort Myers, Florida, United States, 33912
      • Covenant Metabolic Specialists, LLC ( Site 3231)
    • Hallandale, Florida, United States, 33009
      • Velocity Clinical Research, Hallandale Beach ( Site 3241)
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center, Inc ( Site 3207)
    • Hialeah, Florida, United States, 33016
      • Sweet Hope Research Specialty, Inc-Research ( Site 3200)
    • Lakewood Rch, Florida, United States, 34211
      • Florida Research Institute ( Site 3243)
    • Miami, Florida, United States, 33173
      • Genoma Research Group ( Site 3242)
    • Miami Lakes, Florida, United States, 33016-1518
      • Floridian Clinical Research, LLC ( Site 3203)
  • Georgia
    • Dalton, Georgia, United States, 30720
      • Southeast Clinical Research Center ( Site 3288)
  • Illinois
    • Chicago, Illinois, United States, 60621
      • Eagle Clinical Research ( Site 3233)
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa ( Site 3213)
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • Kansas City Research Institute ( Site 3249)
  • Nevada
    • Las Vegas, Nevada, United States, 89101
      • The Machuca Foundation ( Site 3234)
  • New York
    • East Syracuse, New York, United States, 13057
      • Velocity Clinical Research, Syracuse ( Site 3227)
    • New York, New York, United States, 10075
      • New York Gastroenterology Associates ( Site 3252)
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Velocity Clinical Research, Cincinnati ( Site 3237)
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Velocity Clinical Research, Providence ( Site 3222)
  • Texas
    • Austin, Texas, United States, 78759
      • Velocity Clinical Research, Austin ( Site 3235)
    • Brownsville, Texas, United States, 78520
      • South Texas Research Institute - Brownsville ( Site 3285)
    • Dallas, Texas, United States, 75230
      • Velocity Clinical Research, Dallas ( Site 3220)
    • Houston, Texas, United States, 77079
      • Houston Research Institute ( Site 3262)
    • San Antonio, Texas, United States, 78215
      • American Research Corporation ( Site 3202)
    • San Antonio, Texas, United States, 78229
      • Pinnacle Clinical Research ( Site 3284)
  • Utah
    • West Jordan, Utah, United States, 84088
      • Velocity Clinical Research, Salt Lake City ( Site 3223)
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Gastroenterology Consultants of Southwest Virginia ( Site 3282)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Histological confirmation of NASH, defined as NAFLD Activity Score (NAS) ≥4 with a score ≥1 point in each component (steatosis, ballooning, and lobular inflammation) AND NASH clinical research network (CRN) fibrosis score of Stage 2 or 3
• 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 of liver disease other than NASH
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Efinopegdutide; Subcutaneous (SC) injection in dose-escalation regimens potentially including doses of 2 mg, 4 mg, 7 mg, and 10 mg; Other Names: MK-6024; HM12525A; JNJ-64565111
Experimental: 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.	Drug: Efinopegdutide; Subcutaneous (SC) injection in dose-escalation regimens potentially including doses of 2 mg, 4 mg, 7 mg, and 10 mg; Other Names: MK-6024; HM12525A; JNJ-64565111
Experimental: 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.	Drug: Efinopegdutide; Subcutaneous (SC) injection in dose-escalation regimens potentially including doses of 2 mg, 4 mg, 7 mg, and 10 mg; Other Names: MK-6024; HM12525A; JNJ-64565111
Placebo Comparator: Placebo; Placebo administered by SC injection once weekly for 52 weeks	Drug: Placebo; SC injection of matching placebo
Active Comparator: 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.	Drug: 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; Other Names: Wegovy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis At Week 52	The NASH Clinical Research Network (CRN) scoring system evaluated by Blinded Independent Central Review (BICR) is used to assess treatment response. The NASH CRN scoring scales are: lobular inflammation score (0-3); hepatocyte ballooning score (0-2); steatosis score (0-3); and fibrosis score (0-4). NASH resolution is defined as a score of 0-1 for inflammation, 0 for ballooning, and any grade of steatosis.	Week 52
Percentage of Participants Who Experienced an Adverse Event (AE)	An adverse event (AE) is a health problem that happens or worsens during a study.	Up to 60 weeks
Percentage of Participants Discontinuing Study Medication Due to an AE	An adverse event (AE) is a health problem that happens or worsens during a study.	Up to 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With ≥1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis At Week 52	Participants will be assessed using the NASH CRN scoring system evaluated by BICR for ≥1-stage improvement in fibrosis without worsening of steatohepatitis. Fibrosis is scored from stage 0 to 4 where 0 = None, 1=Perisinusoidal OR periportal, 2=Perisinusoidal AND portal/periportal, 3= Bridging fibrosis, 4=Cirrhosis. No worsening of steatohepatitis is defined as no increase in the ballooning, inflammation, or steatosis scores.	Week 52
Change from Baseline in Body Weight At Week 52	Body weight (kg) will be measured using a standardized, digital scale. The percent change from baseline in body weight after 52 weeks will be reported.	Week 52

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information
• Plain Language Summary

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2023
• Primary Completion (Actual): December 29, 2025
• Study Completion (Actual): December 29, 2025

Study Registration Dates

• First Submitted: May 17, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 26, 2023

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Glucagon-Like Peptide-1 Receptor Agonists; Physiological Effects of Drugs; Hypoglycemic Agents; semaglutide
• Other Study ID Numbers: 6024-013; 2022-502647-35-00 (Registry Identifier: EU CT); MK-6024-013 (Other Identifier: MSD); jRCT2031230187 (Registry Identifier: jRCT); U1111-1285-0933 (Registry Identifier: UTN)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No