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

April 5, 2024 updated by: Merck Sharp & Dohme LLC

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Recruiting
        • Medizinische Universität Graz-Department of Internal Medicine ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: +43 676 3250561
  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Recruiting
        • Antwerp University Hospital-Gastr-enterologie/hepatologie ( Site 3300)
        • Contact:
          • Study Coordinator
          • Phone Number: 3238213324
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Recruiting
        • AZ Maria Middelares-Digestief Centrum ( Site 3301)
        • Contact:
          • Study Coordinator
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3001
        • Recruiting
        • UZ Leuven-Hepatology ( Site 3302)
        • Contact:
          • Study Coordinator
          • Phone Number: +3216344299
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • Recruiting
        • Heritage Medical Research Clinic ( Site 0403)
        • Contact:
          • Study Coordinator
          • Phone Number: 4035925049
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Recruiting
        • Vancouver General Hospital-Gastroenterology ( Site 0408)
        • Contact:
          • Study Coordinator
          • Phone Number: 6048755223
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • Toronto General Hospital ( Site 0402)
        • Contact:
          • Study Coordinator
          • Phone Number: 4163403312
    • Quebec
      • Montréal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre ( Site 0400)
        • Contact:
          • Study Coordinator
          • Phone Number: 5148432090
  • Chile
    • Region M. De Santiago
      • Providencia, Region M. De Santiago, Chile, 7500587
        • Recruiting
        • Enroll SpA ( Site 0501)
        • Contact:
          • Study Coordinator
          • Phone Number: 964790949
      • Santiago, Region M. De Santiago, Chile, 8320000
        • Recruiting
        • CECIM ( Site 0500)
        • Contact:
          • Study Coordinator
          • Phone Number: +56968352630
      • Santiago, Region M. De Santiago, Chile, 8330032
        • Recruiting
        • Pontificia Universidad Catolica de Chile-CICUC ( Site 0502)
        • Contact:
          • Study Coordinator
          • Phone Number: 569 9737 4444
  • China
    • Beijing
      • Beijing, Beijing, China, 102218
        • Recruiting
        • Beijing Tsinghua Changgung Hospital ( Site 0606)
        • Contact:
          • Study Coordinator
          • Phone Number: 13601281862
      • Beijing, Beijing, China, 100069
        • Recruiting
        • Beijing Youan Hospital ( Site 0602)
        • Contact:
          • Study Coordinator
          • Phone Number: 8613391859683
    • Chongqing
      • Wanzhou, Chongqing, China, 404199
        • Recruiting
        • Chongqing Three Gorges Central Hospital ( Site 0607)
        • Contact:
          • Study Coordinator
          • Phone Number: 13996835633
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Southern Medical University Nanfang Hospital ( Site 0601)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 13802727354
    • Jiangsu
      • Nanjing, Jiangsu, China, 210037
        • Recruiting
        • No. 2 Hospital of Nanjing ( Site 0605)
        • Contact:
          • Study Coordinator
          • Phone Number: +8613951990210
    • Sichuan
      • Cheng Du, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University ( Site 0611)
        • Contact:
          • Study Coordinator
          • Phone Number: 18000573781
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University ( Site 0609)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 13967781644
  • Czechia
      • Liberec, Czechia, 460 63
        • Recruiting
        • Krajská nemocnice Liberec ( Site 0800)
        • Contact:
          • Study Coordinator
          • Phone Number: +42048531111
      • Praha 2, Czechia, 128 08
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze ( Site 0802)
        • Contact:
          • Study Coordinator
          • Phone Number: 00420224962506
    • Praha 2
      • Prague, Praha 2, Czechia, 120 00
        • Recruiting
        • KlinMed ( Site 0801)
        • Contact:
          • Study Coordinator
          • Phone Number: 420973203048
  • France
      • Paris, France, 75679
        • Recruiting
        • Hopitaux Universitaires Paris Centre-Hopital Cochin-Service HEPATOLOGIE- Recherche Clinique ( Site 0
        • Contact:
          • Study Coordinator
          • Phone Number: +33158413001
      • Paris, France, 75012
        • Recruiting
        • Hôpital Saint Antoine ( Site 0914)
        • Contact:
          • Study Coordinator
          • Phone Number: 33149283274
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06202
        • Recruiting
        • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet-Pôle de Référence Hépato Gastro-entérol
        • Contact:
          • Study Coordinator
          • Phone Number: 33492035972
    • Aquitaine
      • Pessac, Aquitaine, France, 33600
        • Recruiting
        • CHU Bordeaux Haut-Leveque-Service d'Hépato-gastroentérologie ( Site 0904)
        • Contact:
          • Study Coordinator
          • Phone Number: +33 557656439
    • Haute-Normandie
      • Rouen, Haute-Normandie, France, 76000
        • Recruiting
        • CHU Charles Nicolle ( Site 0910)
        • Contact:
          • Study Coordinator
          • Phone Number: 0232886633
    • Hauts-de-Seine
      • Clichy, Hauts-de-Seine, France, 92110
        • Recruiting
        • Hôpital Beaujon-Hépatologie ( Site 0908)
        • Contact:
          • Study Coordinator
          • Phone Number: +33140875764
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49933
        • Recruiting
        • Centre Hospitalier Universitaire d'Angers-Hepato Gastroenterology ( Site 0900)
        • Contact:
          • Study Coordinator
          • Phone Number: +33241353142
    • Puy-de-Dome
      • Clermont-Ferrand, Puy-de-Dome, France, 63100
        • Recruiting
        • Centre Hospitalier Universitaire Estaing ( Site 0913)
        • Contact:
          • Study Coordinator
          • Phone Number: 33473750523
    • Rhone-Alpes
      • Lyon, Rhone-Alpes, France, 69004
        • Recruiting
        • Hôpital de la Croix Rousse-Centre de Recherche Clinique ( Site 0911)
        • Contact:
          • Study Coordinator
          • Phone Number: 0033426109410
      • Pierre-Bénite, Rhone-Alpes, France, 69494 Cédex
        • Recruiting
        • centre hospitalier lyon sud-Endocrinologie, Diabète et Nutrition ( Site 0906)
        • Contact:
          • Study Coordinator
          • Phone Number: +33478861489
  • Hong Kong
      • Shatin, Hong Kong
        • Recruiting
        • Prince of Wales Hospital ( Site 1000)
        • Contact:
          • Study Coordinator
          • Phone Number: 852-92176788
  • Hungary
      • Budapest, Hungary, 1036
        • Recruiting
        • SYNEXUS Magyarország Kft. Eü. ( Site 1110)
        • Contact:
          • Study Coordinator
          • Phone Number: 36704508040
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus ( Site 1304)
        • Contact:
          • Study Coordinator
          • Phone Number: +972 54 4746115
      • Haifa, Israel, 3436212
        • Recruiting
        • Carmel Hospital ( Site 1305)
        • Contact:
          • Study Coordinator
          • Phone Number: 97248250053
      • Jerusalem, Israel, 9778419
        • Recruiting
        • Shaare Zedek Medical Center-Liver Unit ( Site 1302)
        • Contact:
          • Study Coordinator
          • Phone Number: 054-5650213
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center ( Site 1301)
        • Contact:
          • Study Coordinator
          • Phone Number: 97239377252
      • Ramat Hasharon, Israel, 4731001
        • Recruiting
        • Maccabi Health Services - Ramat Hasharon ( Site 1303)
        • Contact:
          • Study Coordinator
          • Phone Number: 97226555116
  • Italy
      • Torino, Italy, 10126
        • Recruiting
        • Azienda Ospedaliero-Universitaria Città della Salute e della-S.C. Gastroenterologia U. ( Site 1401)
        • Contact:
          • Study Coordinator
          • Phone Number: +390116336224
    • Lazio
      • Roma, Lazio, Italy, oo168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Dipartimento di Medicina Interna e Gas
        • Contact:
          • Study Coordinator
          • Phone Number: 0039 06 3015 4469
    • Lombardia
      • Milano, Lombardia, Italy, 20122
        • Recruiting
        • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 1403)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 02 55033301
      • Rozzano, Lombardia, Italy, 20089
        • Recruiting
        • Humanitas-Medicina interna ed Epatologia ( Site 1400)
        • Contact:
          • Study Coordinator
          • Phone Number: 00393286662729
    • Sicilia
      • Palermo, Sicilia, Italy, 90127
        • Recruiting
        • A.O.U. Policlinico Paolo Giaccone-Dep. Of Internal Medicine and Specialistic ( Site 1402)
        • Contact:
          • Study Coordinator
          • Phone Number: 390916552106
  • Japan
      • Fukui, Japan, 918-8503
        • Recruiting
        • Fukuiken Saiseikai Hospital ( Site 1507)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-776-23-1111
      • Gifu, Japan, 500-8513
        • Recruiting
        • Gifu Municipal Hospital ( Site 1506)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-952-34-3010
      • Kyoto, Japan, 602-8566
        • Recruiting
        • University Hospital,Kyoto Prefectural University of Medicine ( Site 1519)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-75-251-5111
      • Okayama, Japan, 700-8505
        • Recruiting
        • Kawasaki Medical School General Medical Center ( Site 1508)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-8-6225-2111
      • Osaka, Japan, 545-8586
        • Recruiting
        • Osaka Metropolitan University Hospital ( Site 1520)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-6-6645-2121
      • Saga, Japan, 849-8501
        • Recruiting
        • Saga University Hospital ( Site 1510)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-952-34-3010
      • Tokyo, Japan, 180-8610
        • Recruiting
        • Japanese Red Cross Musashino Hospital ( Site 1517)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-422-32-3111
    • Ehime
      • Toon, Ehime, Japan, 7910295
        • Recruiting
        • Ehime University Hospital ( Site 1509)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-89-964-5111
    • Fukuoka
      • Kurume, Fukuoka, Japan, 830-0011
        • Recruiting
        • Kurume University Hospital ( Site 1504)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-942-35-3311
    • Gifu
      • Ogaki, Gifu, Japan, 503-0864
        • Recruiting
        • Ogaki Municipal Hospital ( Site 1511)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-5-8481-3341
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0033
        • Recruiting
        • Sapporo Kosei General Hospital ( Site 1521)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-11-261-5331
    • Kagawa
      • Kita, Kagawa, Japan, 761-0701
        • Recruiting
        • Kagawa University Hospital ( Site 1515)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-87-898-5111
      • Takamatsu, Kagawa, Japan, 760-8557
        • Recruiting
        • Kagawa Prefectural Central Hospital ( Site 1514)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-87-811-3333
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 215-0026
        • Recruiting
        • Shinyurigaoka General Hospital ( Site 1518)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-44-322-9991
      • Kawasaki, Kanagawa, Japan, 216-8511
        • Recruiting
        • St. Marianna University Hospital ( Site 1516)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-44-977-8111
      • Kawasaki, Kanagawa, Japan, 105-8470
        • Recruiting
        • Toranomon Hospital Kajigaya ( Site 1502)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-44-877-5111
      • Yokohama, Kanagawa, Japan, 236-0004
        • Recruiting
        • Yokohama City University Hospital ( Site 1505)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-4-5787-2800
    • Nagano
      • Matsumoto, Nagano, Japan, 390-8621
        • Recruiting
        • Shinshu University Hospital ( Site 1512)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-263-37-3389
    • Nara
      • Kashihara, Nara, Japan, 634-0813
        • Recruiting
        • Nara Medical University Hospital ( Site 1513)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-744-22-3051
    • Osaka
      • Suita, Osaka, Japan, 564-0013
        • Recruiting
        • Osaka Saiseikai Suita Hospital ( Site 1503)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-6-6382-1521
    • Tokyo
      • Minato-ku, Tokyo, Japan, 105-8470
        • Recruiting
        • Toranomon Hospital ( Site 1501)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3588-1111
  • Korea, Republic of
      • Incheon, Korea, Republic of, 22332
        • Recruiting
        • Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2402)
        • Contact:
          • Study Coordinator
          • Phone Number: +82328902548
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 2400)
        • Contact:
          • Study Coordinator
          • Phone Number: +82234103878
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System ( Site 2401)
        • Contact:
          • Study Coordinator
          • Phone Number: +82222281988
    • Seoul
      • Dongjak-gu, Seoul, Korea, Republic of, 07061
        • Recruiting
        • Boramae Medical Center-Internal Medicine ( Site 2403)
        • Contact:
          • Study Coordinator
  • Portugal
      • Viana do Castelo, Portugal, 4904 - 858
        • Recruiting
        • ULSAM - Hospital de Santa Luzia ( Site 1907)
        • Contact:
          • Study Coordinator
    • Braga
      • Guimarães, Braga, Portugal, 4800-055
        • Recruiting
        • Centro Hospitalar do Alto Ave - Hospital Senhora da Oliveira-Internal Medicine ( Site 1905)
        • Contact:
          • Study Coordinator
          • Phone Number: +351912561248
    • Lisboa
      • Lisbon, Lisboa, Portugal, 1649-035
        • Recruiting
        • Centro Hospitalar Universitário Lisboa Norte, E.P.E. - Hospital de Santa Maria ( Site 1904)
        • Contact:
          • Study Coordinator
          • Phone Number: +351918188955
      • Lisbon, Lisboa, Portugal, 1349-019
        • Recruiting
        • Centro Hospitalar de Lisboa Ocidental - Hospital de Egas Moniz ( Site 1906)
        • Contact:
          • Study Coordinator
          • Phone Number: 351919865307
  • Puerto Rico
      • Guaynabo, Puerto Rico, 00970
        • Recruiting
        • ISIS CLINICAL RESEARCH CENTER ( Site 2006)
        • Contact:
          • Study Coordinator
          • Phone Number: 7874045252
      • Rio Piedras, Puerto Rico, 00935
        • Recruiting
        • Pan American Center for Oncology Trials ( Site 2000)
        • Contact:
          • Study Coordinator
          • Phone Number: 787-362-9625
      • San Juan, Puerto Rico, 00907
        • Recruiting
        • Klinical Investigations Group-Clinical Research ( Site 2001)
        • Contact:
          • Study Coordinator
          • Phone Number: 7879197865
      • San Juan, Puerto Rico, 00909
        • Recruiting
        • Latin Clinical Trial Center ( Site 2004)
        • Contact:
          • Study Coordinator
          • Phone Number: 7879859911
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 169608
        • Recruiting
        • Singapore General Hospital ( Site 2188)
        • Contact:
          • Study Coordinator
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 2507)
        • Contact:
          • Study Coordinator
          • Phone Number: 34-666630248
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz-HEPATOLOGIA ( Site 2509)
        • Contact:
          • Study Coordinator
          • Phone Number: 34912071876
      • Madrid, Spain, 28222
        • Recruiting
        • HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Gastroenterologia y Hepatologia ( Site 2500)
        • Contact:
          • Study Coordinator
          • Phone Number: 34607945067
      • Sevilla, Spain, 41013
        • Recruiting
        • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos Clínicos de Aparato Digestivo ( Site 2504)
        • Contact:
          • Study Coordinator
          • Phone Number: 955012065
    • Andalucia
      • Malaga, Andalucia, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 2506)
        • Contact:
          • Study Coordinator
          • Phone Number: 34637784371
    • Cantabria
      • Santander, Cantabria, Spain, 39005
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 2505)
        • Contact:
          • Study Coordinator
          • Phone Number: 942204089
    • Ciudad Real
      • Tomelloso, Ciudad Real, Spain, 13700
        • Recruiting
        • Hospital General de Tomelloso-Aparato Digestivo ( Site 2514)
        • Contact:
          • Study Coordinator
          • Phone Number: 0034926525927
    • La Coruna
      • A Coruña, La Coruna, Spain, 15006
        • Recruiting
        • CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 2511)
        • Contact:
          • Study Coordinator
          • Phone Number: 34655624017
      • Santiago de Compostela, La Coruna, Spain, 15706
        • Recruiting
        • CHUS - Hospital Clinico Universitario ( Site 2503)
        • Contact:
          • Study Coordinator
          • Phone Number: 34981951370
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal ( Site 2508)
        • Contact:
          • Study Coordinator
          • Phone Number: 34913368589
  • Switzerland
    • Sankt Gallen
      • st.Gallen, Sankt Gallen, Switzerland, 9007
        • Recruiting
        • Cantonal Hospital St.Gallen-Klinik für Gastroenterologie / Hepatologie ( Site 2601)
        • Contact:
          • Study Coordinator
          • Phone Number: 0041714941191
    • Ticino
      • Lugano, Ticino, Switzerland, 6900
        • Recruiting
        • Fondazione Epatocentro Ticino ( Site 2602)
        • Contact:
          • Study Coordinator
          • Phone Number: 41919608503
    • Zurich
      • Zürich, Zurich, Switzerland, 8091
        • Recruiting
        • UniversitätsSpital Zürich-Gastroenterologie & Hepatologie ( Site 2603)
        • Contact:
          • Study Coordinator
          • Phone Number: +41765124627
  • Taiwan
      • Taichung, Taiwan, 407
        • Recruiting
        • Taichung Veterans General Hospital ( Site 2703)
        • Contact:
          • Study Coordinator
          • Phone Number: 8864235925253309
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital-Liver Research team of National Cheng Kung University Hospi
        • Contact:
          • Study Coordinator
          • Phone Number: +886 6 235 3535
      • Taipei, Taiwan, 11217
        • Recruiting
        • Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine (
        • Contact:
          • Study Coordinator
          • Phone Number: +886938590872
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital-Internal Medicine ( Site 2700)
        • Contact:
          • Study Coordinator
          • Phone Number: +886972651071
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Medical Foundation-Linkou Branch ( Site 2702)
        • Contact:
          • Study Coordinator
          • Phone Number: 886975366077
    • Changhua
      • Changhua County, Changhua, Taiwan, 50006
        • Recruiting
        • Changhua Christian Hospital-Endocrinology and metabolism ( Site 2704)
        • Contact:
          • Study Coordinator
          • Phone Number: 886-7238595-3239
    • Chiayi
      • Chiayi City, Chiayi, Taiwan, 600
        • Recruiting
        • Chiayi Christian Hospital ( Site 2707)
        • Contact:
          • Study Coordinator
          • Phone Number: +886 971-000-208
  • Thailand
    • Chiang Mai
      • Muang, Chiang Mai, Thailand, 50200
        • Recruiting
        • Maharaj Nakorn Chiang Mai Hospital ( Site 2801)
        • Contact:
          • Study Coordinator
          • Phone Number: +6653936445
    • Krung Thep Maha Nakhon
      • Bangkok, Krung Thep Maha Nakhon, Thailand, 10330
        • Recruiting
        • Chulalongkorn University ( Site 2800)
        • Contact:
          • Study Coordinator
          • Phone Number: +66611589900
      • Bangkok, Krung Thep Maha Nakhon, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital-Department of Medicine ( Site 2802)
        • Contact:
          • Study Coordinator
          • Phone Number: +66241972813
  • Turkey
      • Ankara, Turkey, 06230
        • Recruiting
        • Hacettepe Universite Hastaneleri-internal diseases ( Site 2901)
        • Contact:
          • Study Coordinator
          • Phone Number: 905332344232
      • Istanbul, Turkey, 34093
        • Recruiting
        • Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 2903)
        • Contact:
          • Study Coordinator
          • Phone Number: +90 532 344 87 18
      • Rize, Turkey, 53100
        • Recruiting
        • Recep Tayyip Erdogan University Training and Research Hospital ( Site 2900)
        • Contact:
          • Study Coordinator
          • Phone Number: +905334403995
      • İzmir, Turkey, 35340
        • Recruiting
        • Dokuz Eylul Universitesi Hastanesi-Gastroenterology ( Site 2905)
        • Contact:
          • Study Coordinator
          • Phone Number: +905059340648
  • United Kingdom
    • England
      • London, England, United Kingdom, E1 1BB
        • Recruiting
        • Royal London Hospital ( Site 3003)
        • Contact:
          • Study Coordinator
          • Phone Number: +447866460778
    • London, City Of
      • London, London, City Of, United Kingdom, SE5 9RL
        • Recruiting
        • King's College Hospital ( Site 3002)
        • Contact:
          • Study Coordinator
          • Phone Number: 02032997615
    • Scotland
      • Aberdeen, Scotland, United Kingdom, AB25 2ZN
        • Recruiting
        • Aberdeen Royal Infirmary-Department of Gastroenterology ( Site 3004)
        • Contact:
          • Study Coordinator
          • Phone Number: 07824394503
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Recruiting
        • The Institute for Liver Health II dba Arizona Clinical Trial-The Institute for Liver Health ( Site 3
        • Contact:
          • Study Coordinator
          • Phone Number: 434-825-0921
      • Peoria, Arizona, United States, 85381
        • Recruiting
        • The Institute for Liver Health II dba Arizona Clinical Trials - Peoria ( Site 3289)
        • Contact:
          • Study Coordinator
          • Phone Number: 480-470-4000
      • Tucson, Arizona, United States, 85715
        • Recruiting
        • Del Sol Research Management, LLC ( Site 3211)
        • Contact:
          • Study Coordinator
          • Phone Number: 520-257-3881
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • The Institute for Liver Health II dba Arizona Liver Health-Tucson ( Site 3218)
        • Contact:
          • Study Coordinator
          • Phone Number: 520-485-4000
    • California
      • Camarillo, California, United States, 93012
        • Recruiting
        • Om Research LLC ( Site 3245)
        • Contact:
          • Study Coordinator
          • Phone Number: 661-388-2239
      • Gardena, California, United States, 90247
        • Recruiting
        • Velocity Clinical Research, Gardena ( Site 3225)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-351-1368
      • Huntington Park, California, United States, 90255
        • Recruiting
        • Velocity Clinical Research, Huntington Park ( Site 3217)
        • Contact:
          • Study Coordinator
          • Phone Number: 323-588-1968
      • La Mesa, California, United States, 91942
        • Recruiting
        • Velocity Clinical Research, San Diego ( Site 3226)
        • Contact:
          • Study Coordinator
          • Phone Number: 619-567-1550
      • Lancaster, California, United States, 93534
        • Recruiting
        • Om Research LLC ( Site 3229)
        • Contact:
          • Study Coordinator
          • Phone Number: 661-388-2239
      • Los Angeles, California, United States, 90057
        • Recruiting
        • Velocity Clinical Research, Westlake ( Site 3216)
        • Contact:
          • Study Coordinator
          • Phone Number: 213-483-1800
      • Panorama City, California, United States, 91402
        • Recruiting
        • Velocity Clinical Research, Panorama City ( Site 3214)
        • Contact:
          • Study Coordinator
          • Phone Number: 818-532-6880
      • Pasadena, California, United States, 91105
        • Recruiting
        • California Liver Research Institute ( Site 3232)
        • Contact:
          • Study Coordinator
          • Phone Number: 626-795-5769
      • Sacramento, California, United States, 95821
        • Recruiting
        • Clinical Trials Research ( Site 3230)
        • Contact:
          • Study Coordinator
          • Phone Number: 001-916-434-8230
    • Florida
      • Bradenton, Florida, United States, 34208
        • Recruiting
        • Synergy Healthcare ( Site 3286)
        • Contact:
          • Study Coordinator
          • Phone Number: 727-888-1978
      • Cutler Bay, Florida, United States, 33189
        • Recruiting
        • Top Medical Research ( Site 3209)
        • Contact:
          • Study Coordinator
          • Phone Number: 305-971-6883
      • Fort Myers, Florida, United States, 33912
        • Recruiting
        • Covenant Metabolic Specialists, LLC ( Site 3231)
        • Contact:
          • Study Coordinator
          • Phone Number: 941-894-2014
      • Hallandale Beach, Florida, United States, 33009
        • Recruiting
        • Velocity Clinical Research, Hallandale Beach ( Site 3241)
        • Contact:
          • Study Coordinator
          • Phone Number: 954-455-5757
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Indago Research & Health Center, Inc ( Site 3207)
        • Contact:
          • Study Coordinator
          • Phone Number: 305-825-6588
      • Hialeah, Florida, United States, 33016
        • Recruiting
        • Sweet Hope Research Specialty, Inc-Research ( Site 3200)
        • Contact:
          • Study Coordinator
          • Phone Number: 786-560-5794
      • Lakewood Ranch, Florida, United States, 34211
        • Recruiting
        • Florida Research Institute ( Site 3243)
        • Contact:
          • Study Coordinator
          • Phone Number: 941-727-7772
      • Miami, Florida, United States, 33173
        • Recruiting
        • Genoma Research Group ( Site 3242)
        • Contact:
          • Study Coordinator
          • Phone Number: 305-392-1264
      • Miami Lakes, Florida, United States, 33016-1518
        • Recruiting
        • Floridian Clinical Research, LLC ( Site 3203)
        • Contact:
          • Study Coordinator
          • Phone Number: 954-439-0531
    • Georgia
      • Dalton, Georgia, United States, 30720
        • Recruiting
        • Southeast Clinical Research Center ( Site 3288)
        • Contact:
          • Study Coordinator
          • Phone Number: 706-913-1779
    • Illinois
      • Chicago, Illinois, United States, 60621
        • Recruiting
        • Eagle Clinical Research ( Site 3233)
        • Contact:
          • Study Coordinator
          • Phone Number: 708-646-1080
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa ( Site 3213)
        • Contact:
          • Study Coordinator
          • Phone Number: 319-335-6707
    • Nevada
      • Las Vegas, Nevada, United States, 89101
        • Recruiting
        • The Machuca Foundation ( Site 3234)
        • Contact:
          • Study Coordinator
          • Phone Number: 725-400-2550
    • New York
      • East Syracuse, New York, United States, 13057
        • Recruiting
        • Velocity Clinical Research, Syracuse ( Site 3227)
        • Contact:
          • Study Coordinator
          • Phone Number: 315-760-5905
      • New York, New York, United States, 10075
        • Recruiting
        • New York Gastroenterology Associates ( Site 3252)
        • Contact:
          • Study Coordinator
          • Phone Number: 347-248-8719
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Recruiting
        • Velocity Clinical Research, Cincinnati ( Site 3237)
        • Contact:
          • Study Coordinator
          • Phone Number: 513-769-2767
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Recruiting
        • Velocity Clinical Research, Providence ( Site 3222)
        • Contact:
          • Study Coordinator
          • Phone Number: 401-739-9350
    • Texas
      • Brownsville, Texas, United States, 78520
        • Recruiting
        • South Texas Research Institute - Brownsville ( Site 3285)
        • Contact:
          • Study Coordinator
          • Phone Number: 956-468-3360
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Velocity Clinical Research, Dallas ( Site 3220)
        • Contact:
          • Study Coordinator
          • Phone Number: 682-348-1169
      • Houston, Texas, United States, 77079
        • Recruiting
        • Houston Research Institute ( Site 3262)
        • Contact:
          • Study Coordinator
          • Phone Number: 818-414-4133
      • San Antonio, Texas, United States, 78215
        • Recruiting
        • American Research Corporation ( Site 3202)
        • Contact:
          • Study Coordinator
          • Phone Number: 210-253-3426
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Pinnacle Clinical Research ( Site 3284)
        • Contact:
          • Study Coordinator
          • Phone Number: 210-982-0320
    • Utah
      • West Jordan, Utah, United States, 84088
        • Recruiting
        • Velocity Clinical Research, Salt Lake City ( Site 3223)
        • Contact:
          • Study Coordinator
          • Phone Number: 801-542-8190
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Gastroenterology Consultants of Southwest Virginia ( Site 3282)
        • Contact:
          • Study Coordinator
          • Phone Number: 540-345-4900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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)
Time Frame: Up to 60 weeks
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
Time Frame: Up to 52 weeks
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
Time Frame: 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
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2023

Primary Completion (Estimated)

December 5, 2025

Study Completion (Estimated)

December 5, 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 (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6024-013
  • 2022-502647-35-00 (Registry Identifier: EU CT)
  • MK-6024-013 (Other Identifier: Merck)
  • jRCT2031230187 (Registry Identifier: jRCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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