AzTrials
AzTrials

Non-alcoholic Fatty Liver DiseasePhase 2NCT05877547

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

A Phase 2 study testing Efinopegdutide and Semaglutide in people with Non-alcoholic Fatty Liver Disease and Fatty Liver, Nonalcoholic, run by Merck Sharp & Dohme LLC at 175 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Efinopegdutide and Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
381 participants
Where
175 sitesin 26 countries
Study dates
23 Jun 2023to 29 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

175 sites in 26 countries.

175 sites in 26 countries

United States42 sites

  • Om Research - Apple Valley ( Site 3244)

    Apple Valley, California, 92307

  • Velocity Clinical Research, Austin ( Site 3235)

    Austin, Texas, 78759

  • Excel Medical Clinical Trials ( Site 3246)

    Boca Raton, Florida, 33434

  • Synergy Healthcare ( Site 3286)

    Bradenton, Florida, 34208

  • Synergy Healthcare LLC ( Site 3290)

    Brandon, Florida, 33511

  • South Texas Research Institute - Brownsville ( Site 3285)

    Brownsville, Texas, 78520

  • Om Research LLC ( Site 3245)

    Camarillo, California, 93012

  • The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 3

    Chandler, Arizona, 85224

  • Eagle Clinical Research ( Site 3233)

    Chicago, Illinois, 60621

  • Velocity Clinical Research, Cincinnati ( Site 3237)

    Cincinnati, Ohio, 45242

  • Top Medical Research ( Site 3209)

    Cutler Bay, Florida, 33189

  • Velocity Clinical Research, Dallas ( Site 3220)

    Dallas, Texas, 75230

  • Southeast Clinical Research Center ( Site 3288)

    Dalton, Georgia, 30720

  • Velocity Clinical Research, Providence ( Site 3222)

    East Greenwich, Rhode Island, 02818

  • Velocity Clinical Research, Syracuse ( Site 3227)

    East Syracuse, New York, 13057

  • Covenant Metabolic Specialists, LLC ( Site 3231)

    Fort Myers, Florida, 33912

  • Velocity Clinical Research, Gardena ( Site 3225)

    Gardena, California, 90247

  • Velocity Clinical Research, Hallandale Beach ( Site 3241)

    Hallandale, Florida, 33009

  • Indago Research & Health Center, Inc ( Site 3207)

    Hialeah, Florida, 33012

  • Sweet Hope Research Specialty, Inc-Research ( Site 3200)

    Hialeah, Florida, 33016

  • Houston Research Institute ( Site 3262)

    Houston, Texas, 77079

  • Velocity Clinical Research, Huntington Park ( Site 3217)

    Huntington Park, California, 90255

  • University of Iowa ( Site 3213)

    Iowa City, Iowa, 52242

  • Kansas City Research Institute ( Site 3249)

    Kansas City, Missouri, 64131

  • Velocity Clinical Research, San Diego ( Site 3226)

    La Mesa, California, 91942

  • Florida Research Institute ( Site 3243)

    Lakewood Rch, Florida, 34211

  • Om Research LLC ( Site 3229)

    Lancaster, California, 93534

  • The Machuca Foundation ( Site 3234)

    Las Vegas, Nevada, 89101

  • Velocity Clinical Research, Westlake ( Site 3216)

    Los Angeles, California, 90057

  • Genoma Research Group ( Site 3242)

    Miami, Florida, 33173

  • Floridian Clinical Research, LLC ( Site 3203)

    Miami Lakes, Florida, 33016-1518

  • New York Gastroenterology Associates ( Site 3252)

    New York, New York, 10075

  • Velocity Clinical Research, Panorama City ( Site 3214)

    Panorama City, California, 91402

  • California Liver Research Institute ( Site 3232)

    Pasadena, California, 91105

  • The Institute for Liver Health II dba Arizona Clinical Trials - Peoria ( Site 3289)

    Peoria, Arizona, 85381

  • Gastroenterology Consultants of Southwest Virginia ( Site 3282)

    Roanoke, Virginia, 24014

  • Clinical Trials Research ( Site 3230)

    Sacramento, California, 95821

  • American Research Corporation ( Site 3202)

    San Antonio, Texas, 78215

  • Pinnacle Clinical Research ( Site 3284)

    San Antonio, Texas, 78229

  • The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 3218)

    Tucson, Arizona, 85712

  • Del Sol Research Management, LLC ( Site 3211)

    Tucson, Arizona, 85715

  • Velocity Clinical Research, Salt Lake City ( Site 3223)

    West Jordan, Utah, 84088

Other trials in United States

Japan21 sites

  • Fukuiken Saiseikai Hospital ( Site 1507)

    Fukui, 918-8503

  • Gifu Municipal Hospital ( Site 1506)

    Gifu, 500-8513

  • Nara Medical University Hospital ( Site 1513)

    Kashihara, Nara, 634-0813

  • Toranomon Hospital Kajigaya ( Site 1502)

    Kawasaki, Kanagawa, 105-8470

  • Shinyurigaoka General Hospital ( Site 1518)

    Kawasaki, Kanagawa, 215-0026

  • St. Marianna University Hospital ( Site 1516)

    Kawasaki, Kanagawa, 216-8511

  • Kagawa University Hospital ( Site 1515)

    Kita, Kagawa-ken, 761-0701

  • Kurume University Hospital ( Site 1504)

    Kurume, Fukuoka, 830-0011

  • University Hospital,Kyoto Prefectural University of Medicine ( Site 1519)

    Kyoto, 602-8566

  • Shinshu University Hospital ( Site 1512)

    Matsumoto, Nagano, 390-8621

  • Toranomon Hospital ( Site 1501)

    Minato-ku, Tokyo, 105-8470

  • Ogaki Municipal Hospital ( Site 1511)

    Ōgaki, Gifu, 503-0864

  • Kawasaki Medical School General Medical Center ( Site 1508)

    Okayama, 700-8505

  • Osaka Metropolitan University Hospital ( Site 1520)

    Osaka, 545-8586

  • Saga University Hospital ( Site 1510)

    Saga, 849-8501

  • Sapporo Kosei General Hospital ( Site 1521)

    Sapporo, Hokkaido, 060-0033

  • Osaka Saiseikai Suita Hospital ( Site 1503)

    Suita, Osaka, 564-0013

  • Kagawa Prefectural Central Hospital ( Site 1514)

    Takamatsu, Kagawa-ken, 760-8557

  • Japanese Red Cross Musashino Hospital ( Site 1517)

    Tokyo, 180-8610

  • Ehime University Hospital ( Site 1509)

    Tōon, Ehime, 7910295

  • Yokohama City University Hospital ( Site 1505)

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

France10 sites

  • Centre Hospitalier Universitaire d'Angers-Hepato Gastroenterology ( Site 0900)

    Angers, Maine-et-Loire, 49933

  • Centre Hospitalier Universitaire Estaing ( Site 0913)

    Clermont-Ferrand, Puy-de-Dome, 63100

  • Hôpital Beaujon-Hépatologie ( Site 0908)

    Clichy, Hauts-de-Seine, 92110

  • Hôpital de la Croix Rousse-Centre de Recherche Clinique ( Site 0911)

    Lyon, Auvergne-Rhône-Alpes, 69004

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Pôle de Référence Hépato Gastro-entérol

    Nice, Alpes-Maritimes, 06202

  • Hôpital Saint Antoine ( Site 0914)

    Paris, 75571

  • Hopitaux Universitaires Paris Centre-Hopital Cochin-Service HEPATOLOGIE- Recherche Clinique ( Site 0

    Paris, 75679

  • CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0904)

    Pessac, Aquitaine, 33600

  • centre hospitalier lyon sud-Endocrinologie, Diabète et Nutrition ( Site 0906)

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69494 Cédex

  • CHU Charles Nicolle ( Site 0910)

    Rouen, Haute-Normandie, 76000

Other trials in France

Spain10 sites

  • CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 2511)

    A Coruña, La Coruna, 15006

  • Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 2507)

    Barcelona, 08035

  • Hospital Universitario Ramón y Cajal ( Site 2508)

    Madrid, Madrid, Comunidad de, 28034

  • Hospital Universitario La Paz-HEPATOLOGIA ( Site 2509)

    Madrid, 28046

  • HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Gastroenterologia y Hepatologia ( Site 2500)

    Madrid, 28222

  • Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 2506)

    Málaga, Andalusia, 29010

  • Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 2505)

    Santander, Cantabria, 39005

  • CHUS - Hospital Clinico Universitario ( Site 2503)

    Santiago de Compostela, La Coruna, 15706

  • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos Clínicos de Aparato Digestivo ( Site 2504)

    Seville, 41013

  • Hospital General de Tomelloso-Aparato Digestivo ( Site 2514)

    Tomelloso, Ciudad Real, 13700

Other trials in Spain

China9 sites

  • Beijing Youan Hospital ( Site 0602)

    Beijing, Beijing Municipality, 100069

  • Beijing Tsinghua Changgung Hospital ( Site 0606)

    Beijing, Beijing Municipality, 102218

  • West China Hospital, Sichuan University ( Site 0611)

    Chengdu, Sichuan, 610041

  • The First Affiliated Hospital, Sun Yat-sen University ( Site 0603)

    Guangzhou, Guangdong, 510080

  • Southern Medical University Nanfang Hospital ( Site 0601)

    Guangzhou, Guangdong, 510515

  • No. 2 Hospital of Nanjing ( Site 0605)

    Nanjing, Jiangsu, 210037

  • Tianjin Second People's Hospital ( Site 0604)

    Tianjin, Tianjin Municipality, 300192

  • Chongqing University Three Gorges Hospital ( Site 0607)

    Wanzhou, Chongqing Municipality, 404000

  • The First Affiliated Hospital of Wenzhou Medical University ( Site 0609)

    Wenzhou, Zhejiang, 325000

Other trials in China

Mexico8 sites

  • ICARO Investigaciones en Medicina ( Site 1608)

    Chihuahua City, 31000

  • Centro de Investigación y Gastroenterología ( Site 1601)

    Cuauhtémoc, 06700

  • Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 1603)

    Mexico City, Mexico City, 14050

  • Centro de Investigación y Gastroenterología - S.C. ( Site 1609)

    Mexico City, 03330

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 1604)

    Monterrey, Nuevo León, 64460

  • Servicios de Oncología Médica Integral - Monterrey ( Site 1611)

    Monterrey, Nuevo León, 66220

  • Oaxaca Site Management Organization ( Site 1613)

    Oaxaca City, 68000

  • Centro de Investigacion Clinica de Oaxaca ( Site 1607)

    Oaxaca City, 68020

Other trials in Mexico

Israel7 sites

  • Barzilai Medical Center ( Site 1306)

    Ashkelon, 7830604

  • Rambam Health Care Campus ( Site 1304)

    Haifa, 3109601

  • Carmel Hospital ( Site 1305)

    Haifa, 3436212

  • Shaare Zedek Medical Center-Liver Unit ( Site 1302)

    Jerusalem, 9778419

  • Rabin Medical Center ( Site 1301)

    Petah Tikva, 4941 492

  • Sheba Medical Center ( Site 1300)

    Ramat Gan, 5265601

  • Maccabi Health Services - Ramat Hasharon ( Site 1303)

    Ramat HaSharon, 4731001

Other trials in Israel

Taiwan7 sites

  • Changhua Christian Hospital-Endocrinology and metabolism ( Site 2704)

    Changhua County, Changhua, 50006

  • Chiayi Christian Hospital ( Site 2707)

    Chiayi City, Chiayi, 600

  • Taichung Veterans General Hospital ( Site 2703)

    Taichung, 407

  • National Cheng Kung University Hospital-Liver Research team of National Cheng Kung University Hospi

    Tainan, 704

  • National Taiwan University Hospital-Internal Medicine ( Site 2700)

    Taipei, 10002

  • Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine (

    Taipei, 11217

  • Chang Gung Medical Foundation-Linkou Branch ( Site 2702)

    Taoyuan, 33305

Other trials in Taiwan

Colombia6 sites

  • Fundacion Santa Fe de Bogota ( Site 0701)

    Bogotá, Cundinamarca, 110111

  • Solano & Terront Servicios Medicos - UNIENDO ( Site 0705)

    Bogotá, Cundinamarca, 110221

  • Fundación Valle del Lili ( Site 0700)

    Cali, Valle del Cauca Department, 760026

  • Fundación Centro de Investigación Clínica CIC ( Site 0704)

    Medellín, Antioquia, 050021

  • Oncomédica S.A.S ( Site 0702)

    Montería, Departamento de Córdoba, 230002

  • Sociedad De Oncología y Hematología Del Cesar SAS ( Site 0708)

    Valledupar, Cesar Department, 200001

Other trials in Colombia

Canada5 sites

  • Heritage Medical Research Clinic ( Site 0403)

    Calgary, Alberta, T2N 4Z6

  • McGill University Health Centre ( Site 0400)

    Montreal, Quebec, H4A 3J1

  • Diex Recherche Quebec Inc. ( Site 0409)

    Québec, Quebec, G1V 4T3

  • Toronto General Hospital ( Site 0402)

    Toronto, Ontario, M5G 2C4

  • Vancouver General Hospital-Gastroenterology ( Site 0408)

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Italy5 sites

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 1403)

    Milan, Lombardy, 20122

  • A.O.U. Policlinico Paolo Giaccone-Dep. Of Internal Medicine and Specialistic ( Site 1402)

    Palermo, Sicily, 90127

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Dipartimento di Medicina Interna e Gas

    Rome, Lazio, 00168

  • Humanitas-Medicina interna ed Epatologia ( Site 1400)

    Rozzano, Lombardy, 20089

  • Azienda Ospedaliero-Universitaria Città della Salute e della-S.C. Gastroenterologia U. ( Site 1401)

    Torino, 10126

Other trials in Italy

Turkey (Türkiye)5 sites

  • Hacettepe Universite Hastaneleri-internal diseases ( Site 2901)

    Ankara, 06230

  • Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 2903)

    Istanbul, 34093

  • T.C. Sağlik Bakanliği- Marmara Üniversitesi İstanbul Pendik -T.C. Sağlik Bakanliği- Marmara Ünivers

    Istanbul, 34899

  • Dokuz Eylul Universitesi Hastanesi-Gastroenterology ( Site 2905)

    Izmir, 35340

  • Recep Tayyip Erdogan University Training and Research Hospital ( Site 2900)

    Rize, 53100

Other trials in Turkey (Türkiye)

United Kingdom5 sites

  • Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 3004)

    Aberdeen, Scotland, AB25 2ZN

  • Queen Elizabeth Hospital Birmingham ( Site 3000)

    Birmingham, Warwickshire, B15 2TH

  • St James's University Hospital ( Site 3005)

    Leeds, LS9 7TF

  • Royal London Hospital ( Site 3003)

    London, England, E1 1BB

  • King's College Hospital ( Site 3002)

    London, London, City of, SE5 9RL

Other trials in United Kingdom

Portugal4 sites

  • Unidade Local de Saúde do Alto Ave - Hospital Senhora da Oliveira ( Site 1905)

    Guimarães, Braga District, 4835-044

  • Unidade Local de Saude Lisboa Ocidental - Hospital Egas Moniz ( Site 1906)

    Lisbon, Lisbon District, 1349-019

  • Unidade Local de Saude de Santa Maria - Hospital de Santa Maria ( Site 1904)

    Lisbon, Lisbon District, 1649-035

  • ULSAM - Hospital de Santa Luzia ( Site 1907)

    Viana do Castelo, 4904 - 858

Other trials in Portugal

Puerto Rico4 sites

  • ISIS CLINICAL RESEARCH CENTER ( Site 2006)

    Guaynabo, 00968

  • Pan American Center for Oncology Trials ( Site 2000)

    Rio Piedras, 00935

  • Klinical Investigations Group-Clinical Research ( Site 2001)

    San Juan, 00909

  • Latin Clinical Trial Center ( Site 2004)

    San Juan, 00909

Other trials in Puerto Rico

South Korea4 sites

  • Boramae Medical Center-Internal Medicine ( Site 2403)

    Dongjak-gu, Seoul, 07061

  • Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2402)

    Incheon, 22332

  • Severance Hospital, Yonsei University Health System ( Site 2401)

    Seoul, 03722

  • Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 2400)

    Seoul, 06351

Other trials in South Korea

Belgium3 sites

  • Antwerp University Hospital-Gastr-enterologie/hepatologie ( Site 3300)

    Edegem, Antwerpen, 2650

  • AZ Maria Middelares-Digestief Centrum ( Site 3301)

    Ghent, Oost-Vlaanderen, 9000

  • UZ Leuven-Hepatology ( Site 3302)

    Leuven, Vlaams-Brabant, 3001

Other trials in Belgium

Chile3 sites

  • Enroll SpA ( Site 0501)

    Providencia, Region M. de Santiago, 7500587

  • CECIM ( Site 0500)

    Santiago, Region M. de Santiago, 8320000

  • Pontificia Universidad Catolica de Chile-CICUC ( Site 0502)

    Santiago, Region M. de Santiago, 8330032

Other trials in Chile

Czechia3 sites

  • Krajská nemocnice Liberec ( Site 0800)

    Liberec, 460 63

  • KlinMed ( Site 0801)

    Prague, Praha 2, 120 00

  • Vseobecna fakultni nemocnice v Praze ( Site 0802)

    Prague, 128 08

Other trials in Czechia

Peru3 sites

  • CLINICA DELGADO-Clinical Research ( Site 1800)

    Miraflores, Lima region, 15074

  • Instituto Médico Soy Diabetico ( Site 1804)

    Piura, 20009

  • Centro de investigacion Clínica Trujillo ( Site 1802)

    Trujillo, La Libertad, 13001

Other trials in Peru

Switzerland3 sites

  • Fondazione Epatocentro Ticino ( Site 2602)

    Lugano, Canton Ticino, 6900

  • Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 2601)

    Sankt Gallen, Canton of St. Gallen, 9007

  • UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 2603)

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Thailand3 sites

  • Chulalongkorn University ( Site 2800)

    Bangkok, Bangkok, 10330

  • Faculty of Medicine Siriraj Hospital-Department of Medicine ( Site 2802)

    Bangkok, Bangkok, 10700

  • Maharaj Nakorn Chiang Mai Hospital ( Site 2801)

    Muang, Chiang Mai, 50200

Other trials in Thailand

Hungary2 sites

  • SYNEXUS Magyarország Kft. Eü. ( Site 1110)

    Budapest, 1036

  • Dél-Pesti Centrumkórház-Hepatologiai Szakrendekő ( Site 1102)

    Budapest, 1097

Other trials in Hungary

Austria1 site

  • Medizinische Universität Graz-Department of Internal Medicine ( Site 0302)

    Graz, Styria, 8036

Other trials in Austria

Hong Kong1 site

  • Prince of Wales Hospital ( Site 1000)

    Shatin

Other trials in Hong Kong

Singapore1 site

  • Singapore General Hospital ( Site 2188)

    Singapore, Central Singapore, 169608

Other trials in Singapore

About this study

Official title: 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.

Being tested
Efinopegdutide, Semaglutide, Placebo
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EfinopegdutideDrug

    Also called MK-6024, HM12525A, JNJ-64565111

    Subcutaneous (SC) injection in dose-escalation regimens potentially including doses of 2 mg, 4 mg, 7 mg, and 10 mg

  • SemaglutideDrug

    Also called Wegovy

    SC injection in a dose-escalation regimen of 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, and 2.4 mg

  • PlaceboDrug

    SC injection of matching placebo

Study groups in NCT05877547
Study groupRoleWhat they receive
Efinopegdutide 4mgExperimentalEfinopegdutide 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.
Receives: Drug: Efinopegdutide
Efinopegdutide 7mgExperimentalEfinopegdutide 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.
Receives: Drug: Efinopegdutide
Efinopegdutide 10mgExperimentalEfinopegdutide 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.
Receives: Drug: Efinopegdutide
PlaceboPlacebo comparatorPlacebo administered by SC injection once weekly for 52 weeks
Receives: Drug: Placebo
Semaglutide 2.4 mgActive comparatorSemaglutide 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.
Receives: Drug: Semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 52

  2. Percentage of Participants Who Experienced an Adverse Event (AE)

    An adverse event (AE) is a health problem that happens or worsens during a study.

    Measured: Up to 60 weeks

  3. 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.

    Measured: Up to 52 weeks

Secondary outcomes (2)

  1. 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.

    Measured: Week 52

  2. 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.

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2023
  2. Study start23 Jun 2023
  3. Primary completion29 Dec 2025
  4. Study completion29 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
381 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05877547
Sponsor's protocol ID
6024-013
Other IDs
2022-502647-35-00, MK-6024-013, jRCT2031230187, U1111-1285-0933
Status last verified
Jan 2026
First submitted
17 May 2023
Last updated
12 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Efinopegdutide and Semaglutide in people with Non-alcoholic Fatty Liver Disease and Fatty Liver, Nonalcoholic, run by Merck Sharp & Dohme LLC at 175 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 175 sites in United States, Japan, France, Spain, China and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis At Week 52 (time frame: Week 52). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05877547.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.

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