A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-3655-001)
NCT ID: NCT04583423
Last Updated: 2025-07-17
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
183 participants
INTERVENTIONAL
2020-11-11
2023-04-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MK-3655 50 mg
Following a 2-week placebo run-in, participants will receive MK-3655 50 mg by subcutaneous (SC) injection once every 4 weeks (Q4W) for 52 weeks.
MK-3655
MK-3655 50, 100 or 300 dose for injection
MK-3655 100 mg
Following a 2-week placebo run-in, participants will receive MK-3655 100 mg by SC injection Q4W for 52 weeks.
MK-3655
MK-3655 50, 100 or 300 dose for injection
MK-3655 300 mg
Following a 2-week placebo run-in, participants will receive MK-3655 300 mg by SC injection Q4W for 52 weeks.
MK-3655
MK-3655 50, 100 or 300 dose for injection
Placebo
Following a 2-week placebo run-in, participants will receive Placebo by SC injection Q4W for 52 weeks.
Placebo
Matching placebo to MK-3655
Interventions
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MK-3655
MK-3655 50, 100 or 300 dose for injection
Placebo
Matching placebo to MK-3655
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Is a male or female aged 18 years to 80 years (in Japan and Taiwan aged 20 to 80 years)
* Has a body mass index (BMI) ≥25 kg/m\^2 and ≤50 kg/m\^2 and stable weight for the past 3 months
* Has no history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM controlled by diet or stable doses of antihyperglycemic agents (AHAs)
* Contraceptive use by male participants should be consistent with local regulations.
* A female participant is eligible to participate if she is not pregnant or breastfeeding, and she is not a woman of child-bearing potential (WOCBP) OR she is a WOCBP and uses a contraceptive method that is highly effective during the intervention period and for at least 16 weeks after the last dose of study intervention.
Exclusion Criteria
* Has Type 1 diabetes
* Has a history of malignancy, unless cancer free ≥5 years, or is under evaluation for active or suspected malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
* Has a history of bariatric surgery ≤5 years before study participation
* Has undergone a major surgical procedure ≤3 months before study participation or has major surgery planned during the study
* Has a history or evidence of chronic liver disease other than NASH. Individuals with a history of Hepatitis B or C may be eligible for participation.
* Has significant systemic or major illnesses other than liver disease, including recent events (≤6 months before study entry) of congestive heart failure, unstable coronary artery disease, arterial revascularization, pulmonary disease, renal failure, stroke, transient ischemic attack, or organ transplantation
18 Years
80 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director, MD
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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Adobe Clinical Research, LLC ( Site 2644)
Tucson, Arizona, United States
Arizona Liver Health ( Site 9026)
Tucson, Arizona, United States
Del Sol Research Management ( Site 2674)
Tucson, Arizona, United States
Arkansas Gastroenterology - North Little Rock ( Site 9015)
North Little Rock, Arkansas, United States
Hope Clinical Research, Inc. ( Site 2601)
Canoga Park, California, United States
Velocity Clinical Research, Huntington Park ( Site 9022)
Huntington Park, California, United States
UCSD - Altman Clinical and Translational Research Institute -UC San Diego NAFLD Research Center ( Si
La Jolla, California, United States
Ruane Clinical Research Group, Inc ( Site 9014)
Los Angeles, California, United States
Velocity Clinical Research, Westlake ( Site 9013)
Los Angeles, California, United States
Catalina Research Institute, LLC ( Site 2643)
Montclair, California, United States
Velocity Clinical Research, Panorama City ( Site 9001)
Panorama City, California, United States
California Liver Research Institute ( Site 9025)
Pasadena, California, United States
Quest Clinical Research ( Site 9011)
San Francisco, California, United States
Velocity Clinical Research, Santa Ana ( Site 9002)
Santa Ana, California, United States
Peak Gastroenterology Associates ( Site 2645)
Colorado Springs, Colorado, United States
Top Medical Research, Inc ( Site 2673)
Cutler Bay, Florida, United States
Covenant Metabolic Specialists, LLC ( Site 9027)
Fort Myers, Florida, United States
North Florida South Georgia Veterans Health System ( Site 2613)
Gainesville, Florida, United States
Indago Research and Health Center Inc ( Site 2610)
Hialeah, Florida, United States
Sweet Hope Research Specialty Inc ( Site 2660)
Hialeah, Florida, United States
Genoma Research Group, Inc. ( Site 2669)
Miami, Florida, United States
Floridian Clinical Research, LLC ( Site 2656)
Miami Lakes, Florida, United States
Ocean Blue Medical Research Center Inc ( Site 2667)
Miami Springs, Florida, United States
Sensible Healthcare Llc ( Site 2607)
Ocoee, Florida, United States
Synexus Research ( Site 2672)
Orlando, Florida, United States
Southeast Clinical Research Center ( Site 9003)
Dalton, Georgia, United States
The University of Iowa ( Site 2655)
Iowa City, Iowa, United States
Legacy Clinical Solutions: Tandem Clinical Research, LLC ( Site 2650)
Marrero, Louisiana, United States
The National Diabetes & Obesity Research Institute ( Site 9017)
Biloxi, Mississippi, United States
Kansas City Research Institute ( Site 9018)
Kansas City, Missouri, United States
Excel Clinical Research, LLC ( Site 2603)
Las Vegas, Nevada, United States
Velocity Clinical Research, Syracuse ( Site 9016)
East Syracuse, New York, United States
NYU Langone Health, New York ( Site 2627)
New York, New York, United States
Hillmont G.I. ( Site 9019)
Flourtown, Pennsylvania, United States
Regional Gastroenterology Associates of Lancaster, LTD ( Site 9020)
Lancaster, Pennsylvania, United States
Regional Gastroenterology Associates of Lancaster, LTD ( Site 9004)
Wyomissing, Pennsylvania, United States
Premier Medical Group ( Site 9010)
Clarksville, Tennessee, United States
Texas Clinical Research Institute ( Site 2619)
Arlington, Texas, United States
The Liver Institute at Methodist Dallas Medical Center ( Site 2638)
Dallas, Texas, United States
DHR Health Institute for Research and Development ( Site 9006)
Edinburg, Texas, United States
South Texas Research Institute ( Site 9012)
Edinburg, Texas, United States
Baylor College of Medicine - Advanced Liver Therapies ( Site 2670)
Houston, Texas, United States
The Crofoot Research Center, Inc. ( Site 2611)
Houston, Texas, United States
Quality Research ( Site 9024)
San Antonio, Texas, United States
American Research Corporation at Texas Liver Institute ( Site 2634)
San Antonio, Texas, United States
Clinical Trials of Texas, LLC ( Site 2614)
San Antonio, Texas, United States
Impact Research Institute ( Site 2685)
Waco, Texas, United States
Virginia Commonwealth University Health System ( Site 2657)
Richmond, Virginia, United States
Instituto de Investigaciones Clínicas Mar del Plata ( Site 0010)
Mar del Plata, Buenos Aires, Argentina
Hospital Universitario Austral ( Site 0003)
Pilar, Buenos Aires, Argentina
DIM Clínica Privada ( Site 0011)
Ramos Mejía, Buenos Aires, Argentina
Hospital Británico de Buenos Aires ( Site 0002)
Buenos Aires, Buenos Aires F.D., Argentina
Glenny Corp. S.A.-CLINICAL RESEARCH ( Site 0013)
Buenos Aires, Buenos Aires F.D., Argentina
Hospital Italiano de Buenos Aires-Hepatology ( Site 0014)
Ciudad de Buenos Aires, Buenos Aires F.D., Argentina
Hospital Provincial del Centenario ( Site 0007)
Rosario, Santa Fe Province, Argentina
Hospital Aleman ( Site 0009)
Buenos Aires, , Argentina
Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0008)
Santa Fe, , Argentina
Royal Prince Alfred Hospital ( Site 0102)
Camperdown, New South Wales, Australia
St George Hospital ( Site 0104)
Kogarah, New South Wales, Australia
Flinders Medical Centre ( Site 0107)
Bedford Park, South Australia, Australia
GIRI GI Research Institute - Vancouver ( Site 0404)
Vancouver, British Columbia, Canada
University Health Network - Toronto General Hospital ( Site 0401)
Toronto, Ontario, Canada
McGill University Health Centre ( Site 0400)
Montreal, Quebec, Canada
Hospital San Juan de Dios de La Serena ( Site 0500)
La Serena, Coquimbo Region, Chile
Clinical Research Chile SpA ( Site 0506)
Valdivia, Los Ríos Region, Chile
Enroll SpA ( Site 0508)
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile ( Site 0501)
Santiago, Region M. de Santiago, Chile
Centro de Investigaciones Clinicas Vina del Mar ( Site 0502)
Viña del Mar, Región de Valparaíso, Chile
Hospital Regional de Concepcion ( Site 0505)
Concepción, Región del Biobío, Chile
Beijing YouAn Hospital, Capital Medical University ( Site 0605)
Beijing, Beijing Municipality, China
Chongqing Three Gorges Central Hospital ( Site 0618)
Wanzhou District, Chongqing Municipality, China
The First People's Hospital of Foshan-Infection Department ( Site 0612)
Foshan, Guangdong, China
General Hospital of Ningxia Medical University ( Site 0607)
Yinchuan, Ningxia, China
Xinhua Hospital Affiliated to Jiaotong University School of Medicine ( Site 0602)
Shanghai, Shanghai Municipality, China
The Affiliated Hospital of Hangzhou Normal University ( Site 0600)
Hangzhou, Zhejiang, China
Fundacion Santa Fe de Bogota ( Site 0705)
Bogotá, Bogota D.C., Colombia
CHU de Nice Hopital de l Archet II ( Site 0800)
Nice, Alpes-Maritimes, France
hopital haut leveque chu de bordeaux-Service d'Hépato-gastroentérologie ( Site 0805)
Pessac, Aquitaine, France
Hopital de la Croix-Rousse ( Site 0809)
Lyon, Auvergne, France
CHU Dijon Bourgogne - Hopital F. Mitterrand ( Site 0816)
Dijon, Bourgogne-Franche-Comté, France
CHU Besançon ( Site 0806)
Besançon, Franche-Comte, France
Centre Hospitalier et Universitaire Dupuytren ( Site 0810)
Limoges, Haute-Vienne, France
Hôpital Beaujon ( Site 0804)
Clichy, Hauts-de-Seine, France
C.H.U. Nancy Hopital de Brabois ( Site 0803)
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
Hôpital Claude Huriez ( Site 0811)
Lille, Nord, France
Hopital Henri Mondor ( Site 0808)
Créteil, Val-de-Marne, France
A.P.H. Paris, Hopital Saint Antoine ( Site 0807)
Paris, , France
Hopital de la Pitie Salpetriere ( Site 0813)
Paris, , France
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0812)
Paris, , France
Universitaetsklinikum Freiburg ( Site 0446)
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitätsklinikum Frankfurt-Medizinische Klinik 1 ( Site 0445)
Frankfurt am Main, Hesse, Germany
Johannes Gutenberg Universitat Mainz ( Site 0442)
Mainz, Rhineland-Palatinate, Germany
Universitaetsklinikum Leipzig ( Site 0447)
Leipzig, Saxony, Germany
Charite Universitaetsmedizin Berlin ( Site 0443)
Berlin, , Germany
Hippokration University Hopsital-4th Department of Internal Medicine ( Site 3300)
Thessaloniki, Central Macedonia, Greece
Queen Mary Hospital ( Site 1003)
Hong Kong, , Hong Kong
Prince of Wales Hospital ( Site 1001)
Shatin, , Hong Kong
Prince of Wales Hospital ( Site 1002)
Shatin, , Hong Kong
Rambam Medical Center ( Site 1201)
Haifa, , Israel
Carmel Medical Center ( Site 1203)
Haifa, , Israel
Shaare Zedek Medical Center ( Site 1205)
Jerusalem, , Israel
Rabin Medical Center ( Site 1204)
Petah Tikva, , Israel
Chaim Sheba Medical Center ( Site 1200)
Ramat Gan, , Israel
Maccabi Health Services - Ramat Hasharon ( Site 1206)
Ramat HaSharon, , Israel
Sourasky Medical Center ( Site 1202)
Tel Aviv, , Israel
IRCCS Istituto Clinico Humanitas di Rozzano ( Site 1303)
Rozzano, Lombardy, Italy
A O U Policlinico di Modena ( Site 1307)
Modena, , Italy
Azienda Ospedaliera Policlinico Umberto I ( Site 1300)
Roma, , Italy
Azienda Ospedaliera Universitaria Integrata Verona ( Site 1301)
Verona, , Italy
Aichi Medical University Hospital ( Site 1402)
Nagakute, Aichi-ken, Japan
Ehime University Hospital ( Site 1417)
Tōon, Ehime, Japan
Ogaki Municipal Hospital ( Site 1409)
Ōgaki, Gifu, Japan
Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 1404)
Sapporo, Hokkaido, Japan
Kanazawa University Hospital ( Site 1419)
Kanazawa, Ishikawa-ken, Japan
Kagawa University Hospital ( Site 1414)
Kita-gun, Kagawa-ken, Japan
Kagawa Prefectural Central Hospital-liver intemal medicine ( Site 1416)
Takamatsu, Kagawa-ken, Japan
Shinyurigaoka General Hospital ( Site 1420)
Kawasaki, Kanagawa, Japan
Yokohama City University Hospital ( Site 1411)
Yokohama, Kanagawa, Japan
Nara Medical University Hospital ( Site 1407)
Kashihara, Nara, Japan
Saiseikai Suita Hospital ( Site 1403)
Suita, Osaka, Japan
Fukui-ken Saiseikai Hospital ( Site 1410)
Fukui, , Japan
Gifu Municipal Hospital ( Site 1408)
Gifu, , Japan
Hiroshima University Hospital ( Site 1413)
Hiroshima, , Japan
Kagoshima University Hospital ( Site 1418)
Kagoshima, , Japan
University Hospital, Kyoto Prefectural University of Medicine ( Site 1405)
Kyoto, , Japan
Kawasaki Medical School General Medical Center ( Site 1412)
Okayama, , Japan
Osaka Metropolitan University Hospital ( Site 1415)
Osaka, , Japan
Toranomon Hospital ( Site 1401)
Tokyo, , Japan
Hospital Kuala Lumpur-Gastroenterology Department ( Site 2701)
Kuala Lumpur, , Malaysia
Centro de Investigacion Medico Biologica y Terapia Avanzada SC ( Site 1511)
Guadalajara, Jalisco, Mexico
Centro de Investigacion Medica de Occidente S.C. ( Site 1514)
Zapopan, Jalisco, Mexico
Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 1515)
Mexico City, Mexico City, Mexico
Medical Care and Research S.A. de C.V. ( Site 1506)
Mérida, Yucatán, Mexico
Centro de Investigacion y Gastroenterologia SC ( Site 1503)
Mexico City, , Mexico
Christchurch Hospital ( Site 1602)
Christchurch, Canterbury, New Zealand
Auckland Clinical Studies Limited ( Site 1600)
Auckland, , New Zealand
Middlemore Clinical Trials ( Site 1601)
Auckland, , New Zealand
Pan American Center for Oncology Trials ( Site 3102)
Rio Piedras, , Puerto Rico
Klinical Investigations Group ( Site 3100)
San Juan, , Puerto Rico
FDI Clinical Research ( Site 3101)
San Juan, , Puerto Rico
City Clinical Hospital named V.M.Buyanova ( Site 1922)
Moscow, Moscow, Russia
Russian University of People Friendship ( Site 1907)
Moscow, Moscow, Russia
Nephrology Clinic of Internal and Prof. Diseases n.a.E.M.Tareev ( Site 1906)
Moscow, Moscow, Russia
Center targetnoy therapy-Gastroenterology ( Site 1918)
Moscow, Moscow, Russia
Medical Rehabilitation Center ( Site 1904)
Moscow, Moscow, Russia
SPb State Budgetary Institution Health Care City Policlinic 17 ( Site 1910)
Saint Petersburg, Sankt-Peterburg, Russia
Scientific research center ECO-security ( Site 1920)
Saint Petersburg, Sankt-Peterburg, Russia
Surgical Clinic "Parada" ( Site 1921)
Saint Petersburg, Sankt-Peterburg, Russia
LLC Astarta ( Site 1912)
Saint Petersburg, Sankt-Peterburg, Russia
Seoul National University Bundang Hospital-Internal Medicine ( Site 2005)
Seongnam, Kyonggi-do, South Korea
Pusan National University Hospital-Internal Medicine ( Site 2010)
Busan, Pusan-Kwangyokshi, South Korea
Chungang University Hospital ( Site 2007)
Dongjak-gu, Seoul, South Korea
Asan Medical Center ( Site 2001)
Songpagu, Seoul, South Korea
Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2006)
Incheon, , South Korea
Seoul National University Hospital ( Site 2003)
Seoul, , South Korea
Hanyang University Seoul Hospital ( Site 2002)
Seoul, , South Korea
Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 2008)
Seoul, , South Korea
Korea University Guro Hospital ( Site 2004)
Seoul, , South Korea
Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 2106)
Santander, Cantabria, Spain
Hospital Clinico Universitario de Santiago ( Site 2104)
Santiago de Compostela, La Coruna, Spain
Hospital Universitario Puerta de Hierro-Majadahonda ( Site 2100)
Majadahonda, Madrid, Spain
Hospital Universitario Virgen del Rocio ( Site 2105)
Seville, Sevilla, Spain
Hospital Universitari Vall d Hebron ( Site 2101)
Barcelona, , Spain
Hospital Clinic de Barcelona ( Site 2102)
Barcelona, , Spain
Karolinska Universitetssjukhuset Huddinge ( Site 2900)
Huddinge, Stockholm County, Sweden
Akademiska sjukhuset ( Site 2901)
Uppsala, Uppsala County, Sweden
Chiayi Christian Hospital ( Site 2308)
Chiayi City, Chiayi, Taiwan
Chung Shan Medical University Hospital ( Site 2307)
Taichung, Taichung, Taiwan
Chang Gung Memorial Hospital - Linkou Branch ( Site 2305)
Taoyuan, Taoyuan, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2302)
Kaohsiung City, , Taiwan
Taichung Veterans General Hospital ( Site 2306)
Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 2304)
Tainan City, , Taiwan
National Taiwan University Hospital ( Site 2301)
Taipei, , Taiwan
Hacettepe Uni. Ic Hastaliklari Anabilim Dali, Nefroloji BD ( Site 2403)
Ankara, , Turkey (Türkiye)
Gazi University Medical Faculty ( Site 2405)
Ankara, , Turkey (Türkiye)
Ankara University Cebeci Research and Application Hospital ( Site 2406)
Ankara, , Turkey (Türkiye)
Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 2402)
Istanbul, , Turkey (Türkiye)
Istanbul Universitesi Tip Fakultesi Hastanesi ( Site 2401)
Istanbul, , Turkey (Türkiye)
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 2400)
Istanbul, , Turkey (Türkiye)
Ege University Medical Faculty ( Site 2404)
Izmir, , Turkey (Türkiye)
Countries
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References
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Raji A, Gantz I, Crutchlow M, Flynn H, Xu L, Rodgers AJ, Krishnan R, Rizk ML, Hu S, Kaufman KD, Engel SS; MK-3655 P001 Study Group. Clinical Trial: A Phase 2b Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-Cirrhotic MASH. Aliment Pharmacol Ther. 2025 Apr;61(7):1152-1162. doi: 10.1111/apt.70038. Epub 2025 Feb 21.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-3655-001
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2051200083
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-003048-63
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
3655-001
Identifier Type: -
Identifier Source: org_study_id
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