A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-3655-001)

A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis.

This study will evaluate the effect of each dose of MK-3655 versus placebo on the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks. The primary hypothesis of the study is that at least 1 dose of MK-3655 is superior to placebo with respect to the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks.

Study Overview

• Status: Terminated
• Conditions: Nonalcoholic Steatohepatitis
• Intervention / Treatment: Drug: MK-3655; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 187
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1118AAT
    • Hospital Aleman ( Site 0009)
  • Santa Fe, Argentina, S3000BPJ
    • Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0008)
  • Buenos Aires
    • Mar del Plata, Buenos Aires, Argentina, 7600
      • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0010)
    • Pilar, Buenos Aires, Argentina, B1629AHJ
      • Hospital Universitario Austral ( Site 0003)
    • Ramos Mejía, Buenos Aires, Argentina, 1704
      • DIM Clínica Privada ( Site 0011)
  • Caba
    • Buenos Aires, Caba, Argentina, 1280
      • Hospital Británico de Buenos Aires ( Site 0002)
    • Buenos Aires, Caba, Argentina, C1430CKE
      • Glenny Corp. S.A.-CLINICAL RESEARCH ( Site 0013)
    • Ciudad de Buenos Aires, Caba, Argentina, C1199ABB
      • Hospital Italiano de Buenos Aires-Hepatology ( Site 0014)
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2002KDS
      • Hospital Provincial del Centenario ( Site 0007)
• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital ( Site 0102)
    • Kogarah, New South Wales, Australia, 2217
      • St George Hospital ( Site 0104)
  • South Australia
    • Bedford Park, South Australia, Australia, 5042
      • Flinders Medical Centre ( Site 0107)
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 2K5
      • GIRI GI Research Institute - Vancouver ( Site 0404)
  • Ontario
    • Toronto, Ontario, Canada, M5G 2C4
      • University Health Network - Toronto General Hospital ( Site 0401)
  • Quebec
    • Montréal, Quebec, Canada, H4A 3J1
      • McGill University Health Centre ( Site 0400)
• Chile
  • Biobio
    • Concepcion, Biobio, Chile, 4070038
      • Hospital Regional de Concepcion ( Site 0505)
  • Coquimbo
    • La Serena, Coquimbo, Chile, 1710216
      • Hospital San Juan de Dios de La Serena ( Site 0500)
  • Los Rios
    • Valdivia, Los Rios, Chile, 5110683
      • Clinical Research Chile SpA ( Site 0506)
  • Region M. De Santiago
    • Santiago, Region M. De Santiago, Chile, 7500587
      • Enroll SpA ( Site 0508)
    • Santiago, Region M. De Santiago, Chile, 8330077
      • Pontificia Universidad Catolica de Chile ( Site 0501)
  • Valparaiso
    • Vina del Mar, Valparaiso, Chile, 2540488
      • Centro de Investigaciones Clinicas Vina del Mar ( Site 0502)
• China
  • Beijing
    • Beijing, Beijing, China, 100069
      • Beijing YouAn Hospital, Capital Medical University ( Site 0605)
  • Chongqing
    • Wanzhou District, Chongqing, China, 404100
      • Chongqing Three Gorges Central Hospital ( Site 0618)
  • Guangdong
    • Foshan, Guangdong, China, 528041
      • The First People's Hospital of Foshan-Infection Department ( Site 0612)
  • Ningxia
    • Yinchuan City, Ningxia, China, 750004
      • General Hospital of Ningxia Medical University ( Site 0607)
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Xinhua Hospital Affiliated to Jiaotong University School of Medicine ( Site 0602)
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310015
      • The Affiliated Hospital of Hangzhou Normal University ( Site 0600)
• Colombia
  • Distrito Capital De Bogota
    • Bogotá, Distrito Capital De Bogota, Colombia, 110111
      • Fundacion Santa Fe de Bogota ( Site 0705)
• France
  • Paris, France, 75012
    • A.P.H. Paris, Hopital Saint Antoine ( Site 0807)
  • Paris, France, 75013
    • Hopital de la Pitie Salpetriere ( Site 0813)
  • Paris, France, 75679
    • Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0812)
  • Alpes-Maritimes
    • Nice, Alpes-Maritimes, France, 06202
      • CHU de Nice Hopital de l Archet II ( Site 0800)
  • Aquitaine
    • Pessac, Aquitaine, France, 33600
      • hopital haut leveque chu de bordeaux-Service d'Hépato-gastroentérologie ( Site 0805)
  • Auvergne
    • Lyon, Auvergne, France, 69004
      • Hopital de la Croix-Rousse ( Site 0809)
  • Bourgogne
    • Dijon, Bourgogne, France, 21079
      • CHU Dijon Bourgogne - Hopital F. Mitterrand ( Site 0816)
  • Franche-Comte
    • Besançon, Franche-Comte, France, 25000
      • CHU Besançon ( Site 0806)
  • Haute-Vienne
    • Limoges, Haute-Vienne, France, 87042
      • Centre Hospitalier et Universitaire Dupuytren ( Site 0810)
  • Hauts-de-Seine
    • Clichy, Hauts-de-Seine, France, 92110
      • Hôpital Beaujon ( Site 0804)
  • Meurthe-et-Moselle
    • Vandoeuvre les Nancy, Meurthe-et-Moselle, France, 54500
      • C.H.U. Nancy Hopital de Brabois ( Site 0803)
  • Nord
    • Lille, Nord, France, 59037
      • Hôpital Claude Huriez ( Site 0811)
  • Val-de-Marne
    • Creteil, Val-de-Marne, France, 94000
      • Hopital Henri Mondor ( Site 0808)
• Germany
  • Berlin, Germany, 13353
    • Charite Universitaetsmedizin Berlin ( Site 0443)
  • Baden-Wurttemberg
    • Freiburg, Baden-Wurttemberg, Germany, 79106
      • Universitaetsklinikum Freiburg ( Site 0446)
  • Hessen
    • Frankfurt, Hessen, Germany, 60590
      • Universitätsklinikum Frankfurt-Medizinische Klinik 1 ( Site 0445)
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • Johannes Gutenberg Universitat Mainz ( Site 0442)
  • Sachsen
    • Leipzig, Sachsen, Germany, 04103
      • Universitaetsklinikum Leipzig ( Site 0447)
• Greece
  • Kentriki Makedonia
    • Thessaloniki, Kentriki Makedonia, Greece, 5 46 42
      • Hippokration University Hopsital-4th Department of Internal Medicine ( Site 3300)
• Hong Kong
  • Hong Kong, Hong Kong, 000000
    • Queen Mary Hospital ( Site 1003)
  • Shatin, Hong Kong
    • Prince of Wales Hospital ( Site 1001)
  • Shatin, Hong Kong
    • Prince of Wales Hospital ( Site 1002)
• Israel
  • Haifa, Israel, 3109601
    • Rambam Medical Center ( Site 1201)
  • Haifa, Israel, 3436212
    • Carmel Medical Center ( Site 1203)
  • Jerusalem, Israel, 9132201
    • Shaare Zedek Medical Center ( Site 1205)
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center ( Site 1204)
  • Ramat Gan, Israel, 5265601
    • Chaim Sheba Medical Center ( Site 1200)
  • Ramat Hasharon, Israel, 4731001
    • Maccabi Health Services - Ramat Hasharon ( Site 1206)
  • Tel Aviv, Israel, 6423906
    • Sourasky Medical Center ( Site 1202)
• Italy
  • Modena, Italy, 41124
    • A O U Policlinico di Modena ( Site 1307)
  • Roma, Italy, 00161
    • Azienda Ospedaliera Policlinico Umberto I ( Site 1300)
  • Verona, Italy, 37134
    • Azienda Ospedaliera Universitaria Integrata Verona ( Site 1301)
  • Lombardia
    • Rozzano, Lombardia, Italy, 20089
      • IRCCS Istituto Clinico Humanitas di Rozzano ( Site 1303)
• Japan
  • Fukui, Japan, 918-8503
    • Fukui-ken Saiseikai Hospital ( Site 1410)
  • Gifu, Japan, 500-8513
    • Gifu Municipal Hospital ( Site 1408)
  • Hiroshima, Japan, 7348551
    • Hiroshima University Hospital ( Site 1413)
  • Kagoshima, Japan, 890-8520
    • Kagoshima University Hospital ( Site 1418)
  • Kyoto, Japan, 602-8566
    • University Hospital, Kyoto Prefectural University of Medicine ( Site 1405)
  • Okayama, Japan, 700-8505
    • Kawasaki Medical School General Medical Center ( Site 1412)
  • Osaka, Japan, 545-8586
    • Osaka Metropolitan University Hospital ( Site 1415)
  • Tokyo, Japan, 105-8470
    • Toranomon Hospital ( Site 1401)
  • Aichi
    • Nagakute, Aichi, Japan, 480-1195
      • Aichi Medical University Hospital ( Site 1402)
  • Ehime
    • Toon, Ehime, Japan, 791-0295
      • Ehime University Hospital ( Site 1417)
  • Gifu
    • Ogaki, Gifu, Japan, 503-8502
      • Ogaki Municipal Hospital ( Site 1409)
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-0033
      • Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 1404)
  • Ishikawa
    • Kanazawa, Ishikawa, Japan, 920-8641
      • Kanazawa University Hospital ( Site 1419)
  • Kagawa
    • Kita-gun, Kagawa, Japan, 761-0793
      • Kagawa University Hospital ( Site 1414)
    • Takamatsu, Kagawa, Japan, 760-0065
      • Kagawa Prefectural Central Hospital-liver intemal medicine ( Site 1416)
  • Kanagawa
    • Kawasaki, Kanagawa, Japan, 215-0026
      • Shinyurigaoka General Hospital ( Site 1420)
    • Yokohama, Kanagawa, Japan, 236-0004
      • Yokohama City University Hospital ( Site 1411)
  • Nara
    • Kashihara, Nara, Japan, 634-8522
      • Nara Medical University Hospital ( Site 1407)
  • Osaka
    • Suita, Osaka, Japan, 564-0013
      • Saiseikai Suita Hospital ( Site 1403)
• Korea, Republic of
  • Incheon, Korea, Republic of, 22332
    • Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2006)
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital ( Site 2003)
  • Seoul, Korea, Republic of, 04763
    • Hanyang University Seoul Hospital ( Site 2002)
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 2008)
  • Seoul, Korea, Republic of, 08308
    • Korea University Guro Hospital ( Site 2004)
  • Kyonggi-do
    • Seongnam, Kyonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital-Internal Medicine ( Site 2005)
  • Pusan-Kwangyokshi
    • Busan, Pusan-Kwangyokshi, Korea, Republic of, 49241
      • Pusan National University Hospital-Internal Medicine ( Site 2010)
  • Seoul
    • Dongjak-gu, Seoul, Korea, Republic of, 06973
      • Chungang University Hospital ( Site 2007)
    • Songpagu, Seoul, Korea, Republic of, 05505
      • Asan Medical Center ( Site 2001)
• Malaysia
  • Kuala Lumpur, Malaysia, 50586
    • Hospital Kuala Lumpur-Gastroenterology Department ( Site 2701)
• Mexico
  • Mexico City, Mexico, 06700
    • Centro de Investigacion y Gastroenterologia SC ( Site 1503)
  • Distrito Federal
    • Mexico City, Distrito Federal, Mexico, 14050
      • Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 1515)
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44130
      • Centro de Investigacion Medico Biologica y Terapia Avanzada SC ( Site 1511)
    • Zapopan, Jalisco, Mexico, 45116
      • Centro de Investigacion Medica de Occidente S.C. ( Site 1514)
  • Yucatan
    • Merida, Yucatan, Mexico, 97070
      • Medical Care and Research S.A. de C.V. ( Site 1506)
• New Zealand
  • Auckland, New Zealand, 1010
    • Auckland Clinical Studies Limited ( Site 1600)
  • Auckland, New Zealand, 2025
    • Middlemore Clinical Trials ( Site 1601)
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8011
      • Christchurch Hospital ( Site 1602)
• Puerto Rico
  • Rio Piedras, Puerto Rico, 00935
    • Pan American Center for Oncology Trials ( Site 3102)
  • San Juan, Puerto Rico, 00909
    • Klinical Investigations Group ( Site 3100)
  • San Juan, Puerto Rico, 00927
    • FDI Clinical Research ( Site 3101)
• Russian Federation
  • Moskva
    • Moscow, Moskva, Russian Federation, 115516
      • City Clinical Hospital named V.M.Buyanova ( Site 1922)
    • Moscow, Moskva, Russian Federation, 117198
      • Russian University of People Friendship ( Site 1907)
    • Moscow, Moskva, Russian Federation, 119435
      • Nephrology Clinic of Internal and Prof. Diseases n.a.E.M.Tareev ( Site 1906)
    • Moscow, Moskva, Russian Federation, 125008
      • Center targetnoy therapy-Gastroenterology ( Site 1918)
    • Moscow, Moskva, Russian Federation, 125367
      • Medical Rehabilitation Center ( Site 1904)
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russian Federation, 196143
      • Scientific research center ECO-security ( Site 1920)
    • Saint Petersburg, Sankt-Peterburg, Russian Federation, 197348
      • Surgical Clinic "Parada" ( Site 1921)
    • Saint Petersburg, Sankt-Peterburg, Russian Federation, 199226
      • LLC Astarta ( Site 1912)
    • St -Petersburg, Sankt-Peterburg, Russian Federation, 194358
      • SPb State Budgetary Institution Health Care City Policlinic 17 ( Site 1910)
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d Hebron ( Site 2101)
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona ( Site 2102)
  • Cantabria
    • Santander, Cantabria, Spain, 39005
      • Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 2106)
  • La Coruna
    • Santiago de Compostela, La Coruna, Spain, 15706
      • Hospital Clinico Universitario de Santiago ( Site 2104)
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro-Majadahonda ( Site 2100)
  • Sevilla
    • Sevila, Sevilla, Spain, 41013
      • Hospital Universitario Virgen del Rocio ( Site 2105)
• Sweden
  • Stockholms Lan
    • Huddinge, Stockholms Lan, Sweden, 141 86
      • Karolinska Universitetssjukhuset Huddinge ( Site 2900)
  • Uppsala Lan
    • Uppsala, Uppsala Lan, Sweden, 751 85
      • Akademiska sjukhuset ( Site 2901)
• Taiwan
  • Kaohsiung, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2302)
  • Taichung, Taiwan, 407
    • Taichung Veterans General Hospital ( Site 2306)
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital ( Site 2304)
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital ( Site 2301)
  • Chiayi
    • Chiayi City, Chiayi, Taiwan, 600
      • Chiayi Christian Hospital ( Site 2308)
  • Taichung
    • Taichung City, Taichung, Taiwan, 402
      • Chung Shan Medical University Hospital ( Site 2307)
  • Taoyuan
    • Taoyuan County, Taoyuan, Taiwan, 333
      • Chang Gung Memorial Hospital - Linkou Branch ( Site 2305)
• Turkey
  • Ankara, Turkey, 06230
    • Hacettepe Uni. Ic Hastaliklari Anabilim Dali, Nefroloji BD ( Site 2403)
  • Ankara, Turkey, 06560
    • Gazi University Medical Faculty ( Site 2405)
  • Ankara, Turkey, 54290
    • Ankara University Cebeci Research and Application Hospital ( Site 2406)
  • Istanbul, Turkey, 34093
    • Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 2402)
  • Istanbul, Turkey, 34093
    • Istanbul Universitesi Tip Fakultesi Hastanesi ( Site 2401)
  • Istanbul, Turkey, 34899
    • Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 2400)
  • Izmir, Turkey, 35100
    • Ege University Medical Faculty ( Site 2404)
• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Adobe Clinical Research, LLC ( Site 2644)
    • Tucson, Arizona, United States, 85712
      • Arizona Liver Health ( Site 9026)
    • Tucson, Arizona, United States, 85715
      • Del Sol Research Management ( Site 2674)
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • Arkansas Gastroenterology - North Little Rock ( Site 9015)
  • California
    • Canoga Park, California, United States, 91303
      • Hope Clinical Research, Inc. ( Site 2601)
    • Huntington Park, California, United States, 90255
      • Velocity Clinical Research, Huntington Park ( Site 9022)
    • La Jolla, California, United States, 92037
      • UCSD - Altman Clinical and Translational Research Institute -UC San Diego NAFLD Research Center ( Si
    • Los Angeles, California, United States, 90036
      • Ruane Clinical Research Group, Inc ( Site 9014)
    • Los Angeles, California, United States, 90057
      • Velocity Clinical Research, Westlake ( Site 9013)
    • Montclair, California, United States, 91763
      • Catalina Research Institute, LLC ( Site 2643)
    • Panorama City, California, United States, 91402
      • Velocity Clinical Research, Panorama City ( Site 9001)
    • Pasadena, California, United States, 91105
      • California Liver Research Institute ( Site 9025)
    • San Francisco, California, United States, 94115
      • Quest Clinical Research ( Site 9011)
    • Santa Ana, California, United States, 92704
      • Velocity Clinical Research, Santa Ana ( Site 9002)
  • Colorado
    • Colorado Springs, Colorado, United States, 80920
      • Peak Gastroenterology Associates ( Site 2645)
  • Florida
    • Cutler Bay, Florida, United States, 33189
      • Top Medical Research, Inc ( Site 2673)
    • Fort Myers, Florida, United States, 33912
      • Covenant Metabolic Specialists, LLC ( Site 9027)
    • Gainesville, Florida, United States, 32608
      • North Florida South Georgia Veterans Health System ( Site 2613)
    • Hialeah, Florida, United States, 33012
      • Indago Research and Health Center Inc ( Site 2610)
    • Hialeah, Florida, United States, 33016
      • Sweet Hope Research Specialty Inc ( Site 2660)
    • Miami, Florida, United States, 33173
      • Genoma Research Group, Inc. ( Site 2669)
    • Miami Lakes, Florida, United States, 33016-1518
      • Floridian Clinical Research, LLC ( Site 2656)
    • Miami Springs, Florida, United States, 33166
      • Ocean Blue Medical Research Center Inc ( Site 2667)
    • Ocoee, Florida, United States, 34761
      • Sensible Healthcare Llc ( Site 2607)
    • Orlando, Florida, United States, 32806
      • Synexus Research ( Site 2672)
  • Georgia
    • Dalton, Georgia, United States, 30720
      • Southeast Clinical Research Center ( Site 9003)
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • The University of Iowa ( Site 2655)
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • Legacy Clinical Solutions: Tandem Clinical Research, LLC ( Site 2650)
  • Mississippi
    • Biloxi, Mississippi, United States, 39532
      • The National Diabetes & Obesity Research Institute ( Site 9017)
  • Missouri
    • Kansas City, Missouri, United States, 64131
      • Kansas City Research Institute ( Site 9018)
  • Nevada
    • Las Vegas, Nevada, United States, 89109
      • Excel Clinical Research, LLC ( Site 2603)
  • New York
    • East Syracuse, New York, United States, 13057
      • Velocity Clinical Research, Syracuse ( Site 9016)
    • New York, New York, United States, 10016
      • NYU Langone Health, New York ( Site 2627)
  • Pennsylvania
    • Flourtown, Pennsylvania, United States, 19031
      • Hillmont G.I. ( Site 9019)
    • Lancaster, Pennsylvania, United States, 17601
      • Regional Gastroenterology Associates of Lancaster, LTD ( Site 9020)
    • Wyomissing, Pennsylvania, United States, 19610
      • Regional Gastroenterology Associates of Lancaster, LTD ( Site 9004)
  • Tennessee
    • Clarksville, Tennessee, United States, 37040
      • Premier Medical Group ( Site 9010)
  • Texas
    • Arlington, Texas, United States, 76012
      • Texas Clinical Research Institute ( Site 2619)
    • Dallas, Texas, United States, 75203
      • The Liver Institute at Methodist Dallas Medical Center ( Site 2638)
    • Edinburg, Texas, United States, 78539
      • DHR Health Institute for Research and Development ( Site 9006)
    • Edinburg, Texas, United States, 78539
      • South Texas Research Institute ( Site 9012)
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine - Advanced Liver Therapies ( Site 2670)
    • Houston, Texas, United States, 77098
      • The Crofoot Research Center, Inc. ( Site 2611)
    • San Antonio, Texas, United States, 78209
      • Quality Research ( Site 9024)
    • San Antonio, Texas, United States, 78215
      • American Research Corporation at Texas Liver Institute ( Site 2634)
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, LLC ( Site 2614)
    • Waco, Texas, United States, 76710
      • Impact Research Institute ( Site 2685)
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University Health System ( Site 2657)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Has histological confirmation of NASH
2. Is a male or female aged 18 years to 80 years (in Japan and Taiwan aged 20 to 80 years)
3. Has a body mass index (BMI) ≥25 kg/m^2 and ≤50 kg/m^2 and stable weight for the past 3 months
4. Has no history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM controlled by diet or stable doses of antihyperglycemic agents (AHAs)
5. Contraceptive use by male participants should be consistent with local regulations.
6. 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

1. Has presence of cirrhosis on liver biopsy
2. Has Type 1 diabetes
3. 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
4. Has a history of bariatric surgery ≤5 years before study participation
5. Has undergone a major surgical procedure ≤3 months before study participation or has major surgery planned during the study
6. 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.
7. 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MK-3655 Low Dose; MK-3655 low dose by subcutaneous (sc) injection once every 4 weeks (Q4W).	Drug: MK-3655; MK-3655 low, middle, or high dose for injection; Other Names: NGM313
Experimental: MK-3655 Middle Dose; MK-3655 middle dose by sc injection Q4W.	Drug: MK-3655; MK-3655 low, middle, or high dose for injection; Other Names: NGM313
Experimental: MK-3655 High Dose; MK-3655 high dose by sc injection Q4W.	Drug: MK-3655; MK-3655 low, middle, or high dose for injection; Other Names: NGM313
Placebo Comparator: Placebo; Matching placebo to MK-3655 by sc injection Q4W.	Drug: Placebo; Matching placebo to MK-3655

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 After 52 Weeks	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 defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.	Up to 56 weeks
Percentage of Participants Discontinuing Study Medication Due to an AE	An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.	Up to 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percent Change from Baseline in Liver Fat Content (LFC) After 24 Weeks	LFC % is measured by Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF) and evaluated by BICR. MRI-PDFF is a highly accurate noninvasive measure of the proportion of fat content of a tissue.	Baseline and Week 24
Percentage of Participants With ≥1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis Assessed With the NASH CRN Scoring System After 52 Weeks	Participants evaluated with the NASH CRN scoring system with BICR with ≥1 stage improvement in fibrosis without worsening of steatohepatitis defined as no increase in the ballooning, inflammation, or steatosis scores.	Week 52
Percentage of Participants With ≥2 Point Improvement in the Nonalcoholic Fatty Liver Disease Activity Score (NAS) Without Worsening of Fibrosis After 52 Weeks	Participants with ≥2 point improvement in the NAS with ≥1 point improvement in inflammation or ballooning without worsening of fibrosis assessed with the NASH CRN scoring system (evaluated by BICR). The NAS is calculated as the unweighted sum of the scores and ranges from 0-8 (highest activity).	Week 52

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2020
• Primary Completion (Actual): April 13, 2023
• Study Completion (Actual): April 13, 2023

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 12, 2020

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Non-alcoholic fatty liver disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 3655-001; MK-3655-001 (Other Identifier: Merck Protocol Number); jRCT2051200083 (Registry Identifier: jRCT); 2019-003048-63 (EudraCT Number)

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
• product manufactured in and exported from the U.S.: No