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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

360

Participants

Timeline

Start Date

June 23, 2023

Primary Completion Date

December 29, 2025

Study Completion Date

December 29, 2025

Conditions
Non-alcoholic Fatty Liver DiseaseFatty Liver, NonalcoholicNAFLDNonalcoholic Fatty Liver DiseaseNonalcoholic Steatohepatitis
Interventions
DRUG

Efinopegdutide

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

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

DRUG

Placebo

SC injection of matching placebo

Trial Locations (175)

407

Taichung Veterans General Hospital ( Site 2703), Taichung

600

Chiayi Christian Hospital ( Site 2707), Chiayi City

704

National Cheng Kung University Hospital-Liver Research team of National Cheng Kung University Hospi, Tainan City

1036

SYNEXUS Magyarország Kft. Eü. ( Site 1110), Budapest

1097

Dél-Pesti Centrumkórház-Hepatologiai Szakrendekő ( Site 1102), Budapest

2650

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

3001

UZ Leuven-Hepatology ( Site 3302), Leuven

6900

Fondazione Epatocentro Ticino ( Site 2602), Lugano

8036

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

8091

UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 2603), Zurich

9000

AZ Maria Middelares-Digestief Centrum ( Site 3301), Ghent

9007

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

10002

National Taiwan University Hospital-Internal Medicine ( Site 2700), Taipei

10075

New York Gastroenterology Associates ( Site 3252), New York

10126

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

10330

Chulalongkorn University ( Site 2800), Bangkok

10700

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

11217

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

13001

Centro de investigacion Clínica Trujillo ( Site 1802), Trujillo

13057

Velocity Clinical Research, Syracuse ( Site 3227), East Syracuse

13700

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

14050

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

15006

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

15074

CLINICA DELGADO-Clinical Research ( Site 1800), Miraflores

15706

CHUS - Hospital Clinico Universitario ( Site 2503), Santiago de Compostela

20009

Instituto Médico Soy Diabetico ( Site 1804), Piura

20089

Humanitas-Medicina interna ed Epatologia ( Site 1400), Rozzano

20122

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 1403), Milan

22332

Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2402), Incheon

24014

Gastroenterology Consultants of Southwest Virginia ( Site 3282), Roanoke

28034

Hospital Universitario Ramón y Cajal ( Site 2508), Madrid

28046

Hospital Universitario La Paz-HEPATOLOGIA ( Site 2509), Madrid

28222

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

29010

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

30720

Southeast Clinical Research Center ( Site 3288), Dalton

31000

ICARO Investigaciones en Medicina ( Site 1608), Chihuahua City

33009

Velocity Clinical Research, Hallandale Beach ( Site 3241), Hallandale

33012

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

33016

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

33173

Genoma Research Group ( Site 3242), Miami

33189

Top Medical Research ( Site 3209), Cutler Bay

33305

Chang Gung Medical Foundation-Linkou Branch ( Site 2702), Taoyuan District

33434

Excel Medical Clinical Trials ( Site 3246), Boca Raton

33511

Synergy Healthcare LLC ( Site 3290), Brandon

33600

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

33912

Covenant Metabolic Specialists, LLC ( Site 3231), Fort Myers

34093

Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 2903), Istanbul

34208

Synergy Healthcare ( Site 3286), Bradenton

34211

Florida Research Institute ( Site 3243), Lakewood Rch

34899

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

35340

Dokuz Eylul Universitesi Hastanesi-Gastroenterology ( Site 2905), Izmir

39005

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

41013

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

45242

Velocity Clinical Research, Cincinnati ( Site 3237), Cincinnati

49933

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

50006

Changhua Christian Hospital-Endocrinology and metabolism ( Site 2704), Changhua County

50200

Maharaj Nakorn Chiang Mai Hospital ( Site 2801), Muang

52242

University of Iowa ( Site 3213), Iowa City

53100

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

60621

Eagle Clinical Research ( Site 3233), Chicago

63100

Centre Hospitalier Universitaire Estaing ( Site 0913), Clermont-Ferrand

64131

Kansas City Research Institute ( Site 3249), Kansas City

64460

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

66220

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

68000

Oaxaca Site Management Organization ( Site 1613), Oaxaca City

68020

Centro de Investigacion Clinica de Oaxaca ( Site 1607), Oaxaca City

69004

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

75230

Velocity Clinical Research, Dallas ( Site 3220), Dallas

75571

Hôpital Saint Antoine ( Site 0914), Paris

75679

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

76000

CHU Charles Nicolle ( Site 0910), Rouen

77079

Houston Research Institute ( Site 3262), Houston

78215

American Research Corporation ( Site 3202), San Antonio

78229

Pinnacle Clinical Research ( Site 3284), San Antonio

78520

South Texas Research Institute - Brownsville ( Site 3285), Brownsville

78759

Velocity Clinical Research, Austin ( Site 3235), Austin

84088

Velocity Clinical Research, Salt Lake City ( Site 3223), West Jordan

85224

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

85381

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

85712

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

85715

Del Sol Research Management, LLC ( Site 3211), Tucson

89101

The Machuca Foundation ( Site 3234), Las Vegas

90057

Velocity Clinical Research, Westlake ( Site 3216), Los Angeles

90127

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

90247

Velocity Clinical Research, Gardena ( Site 3225), Gardena

90255

Velocity Clinical Research, Huntington Park ( Site 3217), Huntington Park

91105

California Liver Research Institute ( Site 3232), Pasadena

91402

Velocity Clinical Research, Panorama City ( Site 3214), Panorama City

91942

Velocity Clinical Research, San Diego ( Site 3226), La Mesa

92110

Hôpital Beaujon-Hépatologie ( Site 0908), Clichy

92307

Om Research - Apple Valley ( Site 3244), Apple Valley

93012

Om Research LLC ( Site 3245), Camarillo

93534

Om Research LLC ( Site 3229), Lancaster

95821

Clinical Trials Research ( Site 3230), Sacramento

100069

Beijing Youan Hospital ( Site 0602), Beijing

102218

Beijing Tsinghua Changgung Hospital ( Site 0606), Beijing

110111

Fundacion Santa Fe de Bogota ( Site 0701), Bogotá

110221

Solano & Terront Servicios Medicos - UNIENDO ( Site 0705), Bogotá

169608

Singapore General Hospital ( Site 2188), Singapore

200001

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

210037

No. 2 Hospital of Nanjing ( Site 0605), Nanjing

230002

Oncomédica S.A.S ( Site 0702), Montería

300192

Tianjin Second People's Hospital ( Site 0604), Tianjin

325000

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

404000

Chongqing University Three Gorges Hospital ( Site 0607), Wanzhou

510080

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

510515

Southern Medical University Nanfang Hospital ( Site 0601), Guangzhou

610041

West China Hospital, Sichuan University ( Site 0611), Chengdu

760026

Fundación Valle del Lili ( Site 0700), Santiago de Cali

3109601

Rambam Health Care Campus ( Site 1304), Haifa

3436212

Carmel Hospital ( Site 1305), Haifa

4731001

Maccabi Health Services - Ramat Hasharon ( Site 1303), Ramat HaSharon

5265601

Sheba Medical Center ( Site 1300), Ramat Gan

7500587

Enroll SpA ( Site 0501), Providencia

7830604

Barzilai Medical Center ( Site 1306), Ashkelon

7910295

Ehime University Hospital ( Site 1509), Tōon

8320000

CECIM ( Site 0500), Santiago

8330032

Pontificia Universidad Catolica de Chile-CICUC ( Site 0502), Santiago

9778419

Shaare Zedek Medical Center-Liver Unit ( Site 1302), Jerusalem

33016-1518

Floridian Clinical Research, LLC ( Site 3203), Miami Lakes

02818

Velocity Clinical Research, Providence ( Site 3222), East Greenwich

T2N 4Z6

Heritage Medical Research Clinic ( Site 0403), Calgary

V5Z 1M9

Vancouver General Hospital-Gastroenterology ( Site 0408), Vancouver

M5G 2C4

Toronto General Hospital ( Site 0402), Toronto

H4A 3J1

McGill University Health Centre ( Site 0400), Montreal

G1V 4T3

Diex Recherche Quebec Inc. ( Site 0409), Québec

050021

Fundación Centro de Investigación Clínica CIC ( Site 0704), Medellín

120 00

KlinMed ( Site 0801), Prague

460 63

Krajská nemocnice Liberec ( Site 0800), Liberec

128 08

Vseobecna fakultni nemocnice v Praze ( Site 0802), Prague

06202

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

69494 Cédex

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

Unknown

Prince of Wales Hospital ( Site 1000), Shatin

4941 492

Rabin Medical Center ( Site 1301), Petah Tikva

00168

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

830-0011

Kurume University Hospital ( Site 1504), Kurume

503-0864

Ogaki Municipal Hospital ( Site 1511), Ōgaki

060-0033

Sapporo Kosei General Hospital ( Site 1521), Sapporo

761-0701

Kagawa University Hospital ( Site 1515), Kita

760-8557

Kagawa Prefectural Central Hospital ( Site 1514), Takamatsu

105-8470

Toranomon Hospital Kajigaya ( Site 1502), Kawasaki

Toranomon Hospital ( Site 1501), Minato-ku

215-0026

Shinyurigaoka General Hospital ( Site 1518), Kawasaki

216-8511

St. Marianna University Hospital ( Site 1516), Kawasaki

236-0004

Yokohama City University Hospital ( Site 1505), Yokohama

390-8621

Shinshu University Hospital ( Site 1512), Matsumoto

634-0813

Nara Medical University Hospital ( Site 1513), Kashihara

564-0013

Osaka Saiseikai Suita Hospital ( Site 1503), Suita

918-8503

Fukuiken Saiseikai Hospital ( Site 1507), Fukui

500-8513

Gifu Municipal Hospital ( Site 1506), Gifu

602-8566

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

700-8505

Kawasaki Medical School General Medical Center ( Site 1508), Okayama

545-8586

Osaka Metropolitan University Hospital ( Site 1520), Osaka

849-8501

Saga University Hospital ( Site 1510), Saga

180-8610

Japanese Red Cross Musashino Hospital ( Site 1517), Tokyo

06700

Centro de Investigación y Gastroenterología ( Site 1601), Cuauhtémoc

03330

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

4835-044

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

1349-019

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

1649-035

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

4904 - 858

ULSAM - Hospital de Santa Luzia ( Site 1907), Viana do Castelo

00968

ISIS CLINICAL RESEARCH CENTER ( Site 2006), Guaynabo

00935

Pan American Center for Oncology Trials ( Site 2000), Rio Piedras

00909

Klinical Investigations Group-Clinical Research ( Site 2001), San Juan

Latin Clinical Trial Center ( Site 2004), San Juan

07061

Boramae Medical Center-Internal Medicine ( Site 2403), Dongjak-gu

03722

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

06351

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

08035

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

06230

Hacettepe Universite Hastaneleri-internal diseases ( Site 2901), Ankara

E1 1BB

Royal London Hospital ( Site 3003), London

SE5 9RL

King's College Hospital ( Site 3002), London

AB25 2ZN

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

B15 2TH

Queen Elizabeth Hospital Birmingham ( Site 3000), Birmingham

LS9 7TF

St James's University Hospital ( Site 3005), Leeds

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY