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

NCT05877547 | Completed Phase 2 DMC FDA Drug

• 5 other identifiers: 6024-0132022-502647-35-00MK-6024-013jRCT2031230187U1111-1285-0933
• Study Type: interventional
• Target: 381
• Locations: 26 countries
• Sites: 175

Brief 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.

Conditions

Fatty Liver, Nonalcoholic; NAFLD; Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Percentage of Participants With ≥1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis At Week 52

  Week 52

• Change from Baseline in Body Weight At Week 52

  Week 52

Study Arms (5)

Efinopegdutide 4mg

EXPERIMENTAL

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

Efinopegdutide 7mg

EXPERIMENTAL

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

Efinopegdutide 10mg

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo administered by SC injection once weekly for 52 weeks

Drug: Placebo

Semaglutide 2.4 mg

ACTIVE COMPARATOR

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

Interventions

Efinopegdutide DRUG

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

Also known as: MK-6024, HM12525A, JNJ-64565111

Efinopegdutide 10mg; Efinopegdutide 4mg; Efinopegdutide 7mg

Semaglutide DRUG

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

Also known as: Wegovy

Semaglutide 2.4 mg

Placebo DRUG

SC injection of matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (175)

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

Chandler, Arizona, 85224, United States

Location

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

Peoria, Arizona, 85381, United States

Location

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

Tucson, Arizona, 85712, United States

Location

Del Sol Research Management, LLC ( Site 3211)

Tucson, Arizona, 85715, United States

Location

Om Research - Apple Valley ( Site 3244)

Apple Valley, California, 92307, United States

Location

Om Research LLC ( Site 3245)

Camarillo, California, 93012, United States

Location

Velocity Clinical Research, Gardena ( Site 3225)

Gardena, California, 90247, United States

Location

Velocity Clinical Research, Huntington Park ( Site 3217)

Huntington Park, California, 90255, United States

Location

Velocity Clinical Research, San Diego ( Site 3226)

La Mesa, California, 91942, United States

Location

Om Research LLC ( Site 3229)

Lancaster, California, 93534, United States

Location

Velocity Clinical Research, Westlake ( Site 3216)

Los Angeles, California, 90057, United States

Location

Velocity Clinical Research, Panorama City ( Site 3214)

Panorama City, California, 91402, United States

Location

California Liver Research Institute ( Site 3232)

Pasadena, California, 91105, United States

Location

Clinical Trials Research ( Site 3230)

Sacramento, California, 95821, United States

Location

Excel Medical Clinical Trials ( Site 3246)

Boca Raton, Florida, 33434, United States

Location

Synergy Healthcare ( Site 3286)

Bradenton, Florida, 34208, United States

Location

Synergy Healthcare LLC ( Site 3290)

Brandon, Florida, 33511, United States

Location

Top Medical Research ( Site 3209)

Cutler Bay, Florida, 33189, United States

Location

Covenant Metabolic Specialists, LLC ( Site 3231)

Fort Myers, Florida, 33912, United States

Location

Velocity Clinical Research, Hallandale Beach ( Site 3241)

Hallandale, Florida, 33009, United States

Location

Indago Research & Health Center, Inc ( Site 3207)

Hialeah, Florida, 33012, United States

Location

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

Hialeah, Florida, 33016, United States

Location

Florida Research Institute ( Site 3243)

Lakewood Rch, Florida, 34211, United States

Location

Genoma Research Group ( Site 3242)

Miami, Florida, 33173, United States

Location

Floridian Clinical Research, LLC ( Site 3203)

Miami Lakes, Florida, 33016-1518, United States

Location

Southeast Clinical Research Center ( Site 3288)

Dalton, Georgia, 30720, United States

Location

Eagle Clinical Research ( Site 3233)

Chicago, Illinois, 60621, United States

Location

University of Iowa ( Site 3213)

Iowa City, Iowa, 52242, United States

Location

Kansas City Research Institute ( Site 3249)

Kansas City, Missouri, 64131, United States

Location

The Machuca Foundation ( Site 3234)

Las Vegas, Nevada, 89101, United States

Location

Velocity Clinical Research, Syracuse ( Site 3227)

East Syracuse, New York, 13057, United States

Location

New York Gastroenterology Associates ( Site 3252)

New York, New York, 10075, United States

Location

Velocity Clinical Research, Cincinnati ( Site 3237)

Cincinnati, Ohio, 45242, United States

Location

Velocity Clinical Research, Providence ( Site 3222)

East Greenwich, Rhode Island, 02818, United States

Location

Velocity Clinical Research, Austin ( Site 3235)

Austin, Texas, 78759, United States

Location

South Texas Research Institute - Brownsville ( Site 3285)

Brownsville, Texas, 78520, United States

Location

Velocity Clinical Research, Dallas ( Site 3220)

Dallas, Texas, 75230, United States

Location

Houston Research Institute ( Site 3262)

Houston, Texas, 77079, United States

Location

American Research Corporation ( Site 3202)

San Antonio, Texas, 78215, United States

Location

Pinnacle Clinical Research ( Site 3284)

San Antonio, Texas, 78229, United States

Location

Velocity Clinical Research, Salt Lake City ( Site 3223)

West Jordan, Utah, 84088, United States

Location

Gastroenterology Consultants of Southwest Virginia ( Site 3282)

Roanoke, Virginia, 24014, United States

Location

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

Graz, Styria, 8036, Austria

Location

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

Edegem, Antwerpen, 2650, Belgium

Location

AZ Maria Middelares-Digestief Centrum ( Site 3301)

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZ Leuven-Hepatology ( Site 3302)

Leuven, Vlaams-Brabant, 3001, Belgium

Location

Heritage Medical Research Clinic ( Site 0403)

Calgary, Alberta, T2N 4Z6, Canada

Location

Vancouver General Hospital-Gastroenterology ( Site 0408)

Vancouver, British Columbia, V5Z 1M9, Canada

Location

Toronto General Hospital ( Site 0402)

Toronto, Ontario, M5G 2C4, Canada

Location

McGill University Health Centre ( Site 0400)

Montreal, Quebec, H4A 3J1, Canada

Location

Diex Recherche Quebec Inc. ( Site 0409)

Québec, Quebec, G1V 4T3, Canada

Location

Enroll SpA ( Site 0501)

Providencia, Region M. de Santiago, 7500587, Chile

Location

CECIM ( Site 0500)

Santiago, Region M. de Santiago, 8320000, Chile

Location

Pontificia Universidad Catolica de Chile-CICUC ( Site 0502)

Santiago, Region M. de Santiago, 8330032, Chile

Location

Beijing Youan Hospital ( Site 0602)

Beijing, Beijing Municipality, 100069, China

Location

Beijing Tsinghua Changgung Hospital ( Site 0606)

Beijing, Beijing Municipality, 102218, China

Location

Chongqing University Three Gorges Hospital ( Site 0607)

Wanzhou, Chongqing Municipality, 404000, China

Location

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

Guangzhou, Guangdong, 510080, China

Location

Southern Medical University Nanfang Hospital ( Site 0601)

Guangzhou, Guangdong, 510515, China

Location

No. 2 Hospital of Nanjing ( Site 0605)

Nanjing, Jiangsu, 210037, China

Location

West China Hospital, Sichuan University ( Site 0611)

Chengdu, Sichuan, 610041, China

Location

Tianjin Second People's Hospital ( Site 0604)

Tianjin, Tianjin Municipality, 300192, China

Location

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

Wenzhou, Zhejiang, 325000, China

Location

Fundación Centro de Investigación Clínica CIC ( Site 0704)

Medellín, Antioquia, 050021, Colombia

Location

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

Valledupar, Cesar Department, 200001, Colombia

Location

Fundacion Santa Fe de Bogota ( Site 0701)

Bogotá, Cundinamarca, 110111, Colombia

Location

Solano & Terront Servicios Medicos - UNIENDO ( Site 0705)

Bogotá, Cundinamarca, 110221, Colombia

Location

Oncomédica S.A.S ( Site 0702)

Montería, Departamento de Córdoba, 230002, Colombia

Location

Fundación Valle del Lili ( Site 0700)

Cali, Valle del Cauca Department, 760026, Colombia

Location

KlinMed ( Site 0801)

Prague, Praha 2, 120 00, Czechia

Location

Krajská nemocnice Liberec ( Site 0800)

Liberec, 460 63, Czechia

Location

Vseobecna fakultni nemocnice v Praze ( Site 0802)

Prague, 128 08, Czechia

Location

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

Nice, Alpes-Maritimes, 06202, France

Location

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

Pessac, Aquitaine, 33600, France

Location

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

Lyon, Auvergne-Rhône-Alpes, 69004, France

Location

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

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

Location

CHU Charles Nicolle ( Site 0910)

Rouen, Haute-Normandie, 76000, France

Location

Hôpital Beaujon-Hépatologie ( Site 0908)

Clichy, Hauts-de-Seine, 92110, France

Location

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

Angers, Maine-et-Loire, 49933, France

Location

Centre Hospitalier Universitaire Estaing ( Site 0913)

Clermont-Ferrand, Puy-de-Dome, 63100, France

Location

Hôpital Saint Antoine ( Site 0914)

Paris, 75571, France

Location

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

Paris, 75679, France

Location

Prince of Wales Hospital ( Site 1000)

Shatin, Hong Kong

Location

SYNEXUS Magyarország Kft. Eü. ( Site 1110)

Budapest, 1036, Hungary

Location

Dél-Pesti Centrumkórház-Hepatologiai Szakrendekő ( Site 1102)

Budapest, 1097, Hungary

Location

Barzilai Medical Center ( Site 1306)

Ashkelon, 7830604, Israel

Location

Rambam Health Care Campus ( Site 1304)

Haifa, 3109601, Israel

Location

Carmel Hospital ( Site 1305)

Haifa, 3436212, Israel

Location

Shaare Zedek Medical Center-Liver Unit ( Site 1302)

Jerusalem, 9778419, Israel

Location

Rabin Medical Center ( Site 1301)

Petah Tikva, 4941 492, Israel

Location

Sheba Medical Center ( Site 1300)

Ramat Gan, 5265601, Israel

Location

Maccabi Health Services - Ramat Hasharon ( Site 1303)

Ramat HaSharon, 4731001, Israel

Location

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

Rome, Lazio, 00168, Italy

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 1403)

Milan, Lombardy, 20122, Italy

Location

Humanitas-Medicina interna ed Epatologia ( Site 1400)

Rozzano, Lombardy, 20089, Italy

Location

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

Palermo, Sicily, 90127, Italy

Location

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

Torino, 10126, Italy

Location

Ehime University Hospital ( Site 1509)

Tōon, Ehime, 7910295, Japan

Location

Kurume University Hospital ( Site 1504)

Kurume, Fukuoka, 830-0011, Japan

Location

Ogaki Municipal Hospital ( Site 1511)

Ōgaki, Gifu, 503-0864, Japan

Location

Sapporo Kosei General Hospital ( Site 1521)

Sapporo, Hokkaido, 060-0033, Japan

Location

Kagawa University Hospital ( Site 1515)

Kita, Kagawa-ken, 761-0701, Japan

Location

Kagawa Prefectural Central Hospital ( Site 1514)

Takamatsu, Kagawa-ken, 760-8557, Japan

Location

Toranomon Hospital Kajigaya ( Site 1502)

Kawasaki, Kanagawa, 105-8470, Japan

Location

Shinyurigaoka General Hospital ( Site 1518)

Kawasaki, Kanagawa, 215-0026, Japan

Location

St. Marianna University Hospital ( Site 1516)

Kawasaki, Kanagawa, 216-8511, Japan

Location

Yokohama City University Hospital ( Site 1505)

Yokohama, Kanagawa, 236-0004, Japan

Location

Shinshu University Hospital ( Site 1512)

Matsumoto, Nagano, 390-8621, Japan

Location

Nara Medical University Hospital ( Site 1513)

Kashihara, Nara, 634-0813, Japan

Location

Osaka Saiseikai Suita Hospital ( Site 1503)

Suita, Osaka, 564-0013, Japan

Location

Toranomon Hospital ( Site 1501)

Minato-ku, Tokyo, 105-8470, Japan

Location

Fukuiken Saiseikai Hospital ( Site 1507)

Fukui, 918-8503, Japan

Location

Gifu Municipal Hospital ( Site 1506)

Gifu, 500-8513, Japan

Location

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

Kyoto, 602-8566, Japan

Location

Kawasaki Medical School General Medical Center ( Site 1508)

Okayama, 700-8505, Japan

Location

Osaka Metropolitan University Hospital ( Site 1520)

Osaka, 545-8586, Japan

Location

Saga University Hospital ( Site 1510)

Saga, 849-8501, Japan

Location

Japanese Red Cross Musashino Hospital ( Site 1517)

Tokyo, 180-8610, Japan

Location

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

Mexico City, Mexico City, 14050, Mexico

Location

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

Monterrey, Nuevo León, 64460, Mexico

Location

Servicios de Oncología Médica Integral - Monterrey ( Site 1611)

Monterrey, Nuevo León, 66220, Mexico

Location

ICARO Investigaciones en Medicina ( Site 1608)

Chihuahua City, 31000, Mexico

Location

Centro de Investigación y Gastroenterología ( Site 1601)

Cuauhtémoc, 06700, Mexico

Location

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

Mexico City, 03330, Mexico

Location

Oaxaca Site Management Organization ( Site 1613)

Oaxaca City, 68000, Mexico

Location

Centro de Investigacion Clinica de Oaxaca ( Site 1607)

Oaxaca City, 68020, Mexico

Location

Centro de investigacion Clínica Trujillo ( Site 1802)

Trujillo, La Libertad, 13001, Peru

Location

CLINICA DELGADO-Clinical Research ( Site 1800)

Miraflores, Lima region, 15074, Peru

Location

Instituto Médico Soy Diabetico ( Site 1804)

Piura, 20009, Peru

Location

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

Guimarães, Braga District, 4835-044, Portugal

Location

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

Lisbon, Lisbon District, 1349-019, Portugal

Location

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

Lisbon, Lisbon District, 1649-035, Portugal

Location

ULSAM - Hospital de Santa Luzia ( Site 1907)

Viana do Castelo, 4904 - 858, Portugal

Location

ISIS CLINICAL RESEARCH CENTER ( Site 2006)

Guaynabo, 00968, Puerto Rico

Location

Pan American Center for Oncology Trials ( Site 2000)

Rio Piedras, 00935, Puerto Rico

Location

Klinical Investigations Group-Clinical Research ( Site 2001)

San Juan, 00909, Puerto Rico

Location

Latin Clinical Trial Center ( Site 2004)

San Juan, 00909, Puerto Rico

Location

Singapore General Hospital ( Site 2188)

Singapore, Central Singapore, 169608, Singapore

Location

Boramae Medical Center-Internal Medicine ( Site 2403)

Dongjak-gu, Seoul, 07061, South Korea

Location

Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2402)

Incheon, 22332, South Korea

Location

Severance Hospital, Yonsei University Health System ( Site 2401)

Seoul, 03722, South Korea

Location

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

Seoul, 06351, South Korea

Location

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

Málaga, Andalusia, 29010, Spain

Location

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

Santander, Cantabria, 39005, Spain

Location

Hospital General de Tomelloso-Aparato Digestivo ( Site 2514)

Tomelloso, Ciudad Real, 13700, Spain

Location

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

A Coruña, La Coruna, 15006, Spain

Location

CHUS - Hospital Clinico Universitario ( Site 2503)

Santiago de Compostela, La Coruna, 15706, Spain

Location

Hospital Universitario Ramón y Cajal ( Site 2508)

Madrid, Madrid, Comunidad de, 28034, Spain

Location

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

Barcelona, 08035, Spain

Location

Hospital Universitario La Paz-HEPATOLOGIA ( Site 2509)

Madrid, 28046, Spain

Location

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

Madrid, 28222, Spain

Location

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

Seville, 41013, Spain

Location

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

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 2603)

Zurich, Canton of Zurich, 8091, Switzerland

Location

Fondazione Epatocentro Ticino ( Site 2602)

Lugano, Canton Ticino, 6900, Switzerland

Location

Changhua Christian Hospital-Endocrinology and metabolism ( Site 2704)

Changhua County, Changhua, 50006, Taiwan

Location

Chiayi Christian Hospital ( Site 2707)

Chiayi City, Chiayi, 600, Taiwan

Location

Taichung Veterans General Hospital ( Site 2703)

Taichung, 407, Taiwan

Location

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

Tainan, 704, Taiwan

Location

National Taiwan University Hospital-Internal Medicine ( Site 2700)

Taipei, 10002, Taiwan

Location

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

Taipei, 11217, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch ( Site 2702)

Taoyuan District, 33305, Taiwan

Location

Chulalongkorn University ( Site 2800)

Bangkok, Bangkok, 10330, Thailand

Location

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

Bangkok, Bangkok, 10700, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital ( Site 2801)

Muang, Chiang Mai, 50200, Thailand

Location

Hacettepe Universite Hastaneleri-internal diseases ( Site 2901)

Ankara, 06230, Turkey (Türkiye)

Location

Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 2903)

Istanbul, 34093, Turkey (Türkiye)

Location

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

Istanbul, 34899, Turkey (Türkiye)

Location

Dokuz Eylul Universitesi Hastanesi-Gastroenterology ( Site 2905)

Izmir, 35340, Turkey (Türkiye)

Location

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

Rize, 53100, Turkey (Türkiye)

Location

Royal London Hospital ( Site 3003)

London, England, E1 1BB, United Kingdom

Location

King's College Hospital ( Site 3002)

London, London, City of, SE5 9RL, United Kingdom

Location

Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 3004)

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Queen Elizabeth Hospital Birmingham ( Site 3000)

Birmingham, Warwickshire, B15 2TH, United Kingdom

Location

St James's University Hospital ( Site 3005)

Leeds, LS9 7TF, United Kingdom

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2023
• First Posted: May 26, 2023
• Study Start: June 23, 2023
• Primary Completion: December 29, 2025
• Study Completion: December 29, 2025
• Last Updated: January 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CO (6); HU (2); US (42); CN (9); CZ (3); IT (5); ME (8); AU (1); HK (1); BE (3); PT (4); KR (4); TW (7); IL (7); JP (21); CA (5); TU (5); TH (3); GB (5); PE (3); FR (10); PR (4); SG (1); CH (3); CL (3); ES (10)