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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05877547
Other study ID # 6024-013
Secondary ID 2022-502647-35-0
Status Recruiting
Phase Phase 2
First received
Last updated
Start date June 23, 2023
Est. completion date December 5, 2025

Study information

Verified date June 2024
Source Merck Sharp & Dohme LLC
Contact Toll Free Number
Phone 1-888-577-8839
Email Trialsites@merck.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 5, 2025
Est. primary completion date December 5, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Intervention

Drug:
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

Locations

Country Name City State
Austria Medizinische Universität Graz-Department of Internal Medicine ( Site 0302) Graz Steiermark
Belgium Antwerp University Hospital-Gastr-enterologie/hepatologie ( Site 3300) Edegem Antwerpen
Belgium AZ Maria Middelares-Digestief Centrum ( Site 3301) Gent Oost-Vlaanderen
Belgium UZ Leuven-Hepatology ( Site 3302) Leuven Vlaams-Brabant
Canada Heritage Medical Research Clinic ( Site 0403) Calgary Alberta
Canada McGill University Health Centre ( Site 0400) Montréal Quebec
Canada Diex Recherche Quebec Inc. ( Site 0409) Quebec
Canada Toronto General Hospital ( Site 0402) Toronto Ontario
Canada Vancouver General Hospital-Gastroenterology ( Site 0408) Vancouver British Columbia
Chile 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
China Beijing Tsinghua Changgung Hospital ( Site 0606) Beijing Beijing
China Beijing Youan Hospital ( Site 0602) Beijing Beijing
China West China Hospital, Sichuan University ( Site 0611) Cheng Du Sichuan
China Chongqing University Three Gorges Hospital ( Site 0607) Chongqing Chongqing
China Southern Medical University Nanfang Hospital ( Site 0601) Guangzhou Guangdong
China The First Affiliated Hospital, Sun Yat-sen University ( Site 0603) Guangzhou Guangdong
China No. 2 Hospital of Nanjing ( Site 0605) Nanjing Jiangsu
China The First Affiliated Hospital of Wenzhou Medical University ( Site 0609) Wenzhou Zhejiang
Colombia Fundacion Santa Fe de Bogota ( Site 0701) Bogotá Cundinamarca
Colombia Solano & Terront Servicios Medicos - UNIENDO ( Site 0705) Bogotá Cundinamarca
Colombia Fundación Valle del Lili ( Site 0700) Cali Valle Del Cauca
Colombia Fundación Centro de Investigación Clínica CIC ( Site 0704) Medellín Antioquia
Colombia Oncomédica S.A.S ( Site 0702) Montería Cordoba
Colombia Sociedad De Oncología y Hematología Del Cesar SAS ( Site 0708) Valledupar Cesar
Czechia Krajská nemocnice Liberec ( Site 0800) Liberec
Czechia KlinMed ( Site 0801) Prague Praha 2
Czechia Vseobecna fakultni nemocnice v Praze ( Site 0802) Praha 2
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 Beaujon-Hépatologie ( Site 0908) Clichy Hauts-de-Seine
France Hôpital de la Croix Rousse-Centre de Recherche Clinique ( Site 0911) Lyon Rhone-Alpes
France Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Pôle de Référence Hépato Gastro-entérol Nice Alpes-Maritimes
France Hôpital Saint Antoine ( Site 0914) Paris
France Hopitaux Universitaires Paris Centre-Hopital Cochin-Service HEPATOLOGIE- Recherche Clinique ( Site 0 Paris
France CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0904) Pessac Aquitaine
France centre hospitalier lyon sud-Endocrinologie, Diabète et Nutrition ( Site 0906) Pierre-Bénite Rhone-Alpes
France CHU Charles Nicolle ( Site 0910) Rouen Haute-Normandie
Hong Kong Prince of Wales Hospital ( Site 1000) Shatin
Hungary SYNEXUS Magyarország Kft. Eü. ( Site 1110) Budapest
Israel Carmel Hospital ( Site 1305) Haifa
Israel Rambam Health Care Campus ( Site 1304) 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
Italy Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 1403) Milano Lombardia
Italy A.O.U. Policlinico Paolo Giaccone-Dep. Of Internal Medicine and Specialistic ( Site 1402) Palermo Sicilia
Italy Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Dipartimento di Medicina Interna e Gas Roma Lazio
Italy Humanitas-Medicina interna ed Epatologia ( Site 1400) Rozzano Lombardia
Italy Azienda Ospedaliero-Universitaria Città della Salute e della-S.C. Gastroenterologia U. ( Site 1401) Torino
Japan Fukuiken Saiseikai Hospital ( Site 1507) Fukui
Japan Gifu Municipal Hospital ( Site 1506) Gifu
Japan Nara Medical University Hospital ( Site 1513) Kashihara Nara
Japan Shinyurigaoka General Hospital ( Site 1518) Kawasaki Kanagawa
Japan St. Marianna University Hospital ( Site 1516) Kawasaki Kanagawa
Japan Toranomon Hospital Kajigaya ( Site 1502) Kawasaki Kanagawa
Japan Kagawa University Hospital ( Site 1515) Kita Kagawa
Japan Kurume University Hospital ( Site 1504) Kurume Fukuoka
Japan University Hospital,Kyoto Prefectural University of Medicine ( Site 1519) Kyoto
Japan Shinshu University Hospital ( Site 1512) Matsumoto Nagano
Japan Toranomon Hospital ( Site 1501) Minato-ku Tokyo
Japan Ogaki Municipal Hospital ( Site 1511) Ogaki Gifu
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 Sapporo Kosei General Hospital ( Site 1521) Sapporo Hokkaido
Japan Osaka Saiseikai Suita Hospital ( Site 1503) Suita Osaka
Japan Kagawa Prefectural Central Hospital ( Site 1514) Takamatsu Kagawa
Japan Japanese Red Cross Musashino Hospital ( Site 1517) Tokyo
Japan Ehime University Hospital ( Site 1509) Toon Ehime
Japan Yokohama City University Hospital ( Site 1505) Yokohama Kanagawa
Korea, Republic of Boramae Medical Center-Internal Medicine ( Site 2403) Dongjak-gu Seoul
Korea, Republic of Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2402) Incheon
Korea, Republic of Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 2400) Seoul
Korea, Republic of Severance Hospital, Yonsei University Health System ( Site 2401) Seoul
Mexico Centro de Investigación y Gastroenterología ( Site 1601) Cuauhtemoc
Mexico Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 1603) Mexico City Distrito Federal
Mexico Centro de Investigacion Clinica de Oaxaca ( Site 1607) Oaxaca
Peru CLINICA DELGADO-Clinical Research ( Site 1800) Miraflores Lima
Peru Instituto Médico Soy Diabetico ( Site 1804) Piura
Peru Centro de investigacion Clínica Trujillo ( Site 1802) Trujillo La Libertad
Portugal Centro Hospitalar do Alto Ave - Hospital Senhora da Oliveira-Internal Medicine ( Site 1905) Guimarães Braga
Portugal Centro Hospitalar de Lisboa Ocidental - Hospital de Egas Moniz ( Site 1906) Lisbon Lisboa
Portugal Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 1904) Lisbon Lisboa
Portugal ULSAM - Hospital de Santa Luzia ( Site 1907) Viana do Castelo
Puerto Rico 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
Singapore Singapore General Hospital ( Site 2188) Singapore Central Singapore
Spain CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 2511) A Coruña La Coruna
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 Ramón y Cajal ( Site 2508) Madrid Madrid, Comunidad De
Spain Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 2506) Malaga Andalucia
Spain Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 2505) Santander Cantabria
Spain CHUS - Hospital Clinico Universitario ( Site 2503) Santiago de Compostela La Coruna
Spain HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos Clínicos de Aparato Digestivo ( Site 2504) Sevilla
Spain Hospital General de Tomelloso-Aparato Digestivo ( Site 2514) Tomelloso Ciudad Real
Switzerland Fondazione Epatocentro Ticino ( Site 2602) Lugano Ticino
Switzerland Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 2601) st.Gallen Sankt Gallen
Switzerland UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 2603) Zürich Zurich
Taiwan 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
Thailand Chulalongkorn University ( Site 2800) Bangkok Krung Thep Maha Nakhon
Thailand Faculty of Medicine Siriraj Hospital-Department of Medicine ( Site 2802) Bangkok Krung Thep Maha Nakhon
Thailand Maharaj Nakorn Chiang Mai Hospital ( Site 2801) Muang Chiang Mai
Turkey Hacettepe Universite Hastaneleri-internal diseases ( Site 2901) Ankara
Turkey Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 2903) Istanbul
Turkey Dokuz Eylul Universitesi Hastanesi-Gastroenterology ( Site 2905) Izmir
Turkey Recep Tayyip Erdogan University Training and Research Hospital ( Site 2900) Rize
United Kingdom Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 3004) Aberdeen Scotland
United Kingdom Queen Elizabeth Hospital Birmingham ( Site 3000) Birmingham England
United Kingdom King's College Hospital ( Site 3002) London London, City Of
United Kingdom Royal London Hospital ( Site 3003) London England
United States Synergy Healthcare ( Site 3286) Bradenton Florida
United States Synergy Healthcare LLC ( Site 3290) Brandon Florida
United States South Texas Research Institute - Brownsville ( Site 3285) Brownsville Texas
United States Om Research LLC ( Site 3245) Camarillo California
United States The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 3 Chandler Arizona
United States Eagle Clinical Research ( Site 3233) Chicago Illinois
United States Velocity Clinical Research, Cincinnati ( Site 3237) Cincinnati Ohio
United States Top Medical Research ( Site 3209) Cutler Bay Florida
United States Velocity Clinical Research, Dallas ( Site 3220) Dallas Texas
United States Southeast Clinical Research Center ( Site 3288) Dalton Georgia
United States Velocity Clinical Research, Providence ( Site 3222) East Greenwich Rhode Island
United States Velocity Clinical Research, Syracuse ( Site 3227) East Syracuse New York
United States Covenant Metabolic Specialists, LLC ( Site 3231) Fort Myers Florida
United States Velocity Clinical Research, Gardena ( Site 3225) Gardena California
United States Velocity Clinical Research, Hallandale Beach ( Site 3241) Hallandale Beach 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 Houston Research Institute ( Site 3262) Houston Texas
United States Velocity Clinical Research, Huntington Park ( Site 3217) Huntington Park California
United States University of Iowa ( Site 3213) Iowa City Iowa
United States Kansas City Research Institute ( Site 3249) Kansas City Missouri
United States Velocity Clinical Research, San Diego ( Site 3226) La Mesa California
United States Florida Research Institute ( Site 3243) Lakewood Ranch Florida
United States Om Research LLC ( Site 3229) Lancaster California
United States The Machuca Foundation ( Site 3234) Las Vegas Nevada
United States Velocity Clinical Research, Westlake ( Site 3216) Los Angeles California
United States Genoma Research Group ( Site 3242) Miami Florida
United States Floridian Clinical Research, LLC ( Site 3203) Miami Lakes Florida
United States New York Gastroenterology Associates ( Site 3252) New York New York
United States Velocity Clinical Research, Panorama City ( Site 3214) Panorama City California
United States California Liver Research Institute ( Site 3232) Pasadena California
United States The Institute for Liver Health II dba Arizona Clinical Trials - Peoria ( Site 3289) Peoria Arizona
United States Gastroenterology Consultants of Southwest Virginia ( Site 3282) Roanoke Virginia
United States Clinical Trials Research ( Site 3230) Sacramento California
United States American Research Corporation ( Site 3202) San Antonio Texas
United States Pinnacle Clinical Research ( Site 3284) San Antonio Texas
United States Del Sol Research Management, LLC ( Site 3211) Tucson Arizona
United States The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 3218) Tucson Arizona
United States Velocity Clinical Research, Salt Lake City ( Site 3223) West Jordan Utah

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  Chile,  China,  Colombia,  Czechia,  France,  Hong Kong,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Peru,  Portugal,  Puerto Rico,  Singapore,  Spain,  Switzerland,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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
Secondary 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
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