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

NCT04583423 | Terminated Phase 2 Results DMC FDA Drug

• 4 other identifiers: 3655-001MK-3655-001jRCT20512000832019-003048-63
• Study Type: interventional
• Target: 183
• Locations: 24 countries
• Sites: 180

Brief Summary

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.

Conditions

Nonalcoholic Steatohepatitis

Keywords

Non-alcoholic fatty liver disease

Outcome Measures

Primary Outcomes (3)

• 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) was used to assess treatment response. The NASH CRN scoring scales were: lobular inflammation score (0-3); hepatocyte ballooning score (0-2); steatosis score (0-3); and fibrosis score (0-4). NASH resolution was 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) was 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 was considered related to the medical treatment or procedure, that occurred during the course of the study.

  Up to 64 weeks

• Percentage of Participants Discontinuing Study Medication Due to an AE

  An adverse event (AE) was 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 was considered related to the medical treatment or procedure, that occurred during the course of the study.

  Up to 52 weeks

Secondary Outcomes (3)

• Mean Percent Relative Reduction From Baseline in Liver Fat Content (LFC) After 24 Weeks

  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

  Week 52

• Percentage of Participants With ≥2 Point Improvement in NAS With ≥1 Point Improvement in Inflammation or Ballooning Without Worsening of Fbrosis by Histology (Evaluated by BICR) After 52 Weeks

  Week 52

Study Arms (4)

MK-3655 50 mg

EXPERIMENTAL

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.

Drug: MK-3655

MK-3655 100 mg

EXPERIMENTAL

Following a 2-week placebo run-in, participants will receive MK-3655 100 mg by SC injection Q4W for 52 weeks.

Drug: MK-3655

MK-3655 300 mg

EXPERIMENTAL

Following a 2-week placebo run-in, participants will receive MK-3655 300 mg by SC injection Q4W for 52 weeks.

Drug: MK-3655

Placebo

PLACEBO COMPARATOR

Following a 2-week placebo run-in, participants will receive Placebo by SC injection Q4W for 52 weeks.

Drug: Placebo

Interventions

MK-3655 DRUG

MK-3655 50, 100 or 300 dose for injection

Also known as: NGM313

MK-3655 100 mg; MK-3655 300 mg; MK-3655 50 mg

Placebo DRUG

Matching placebo to MK-3655

Placebo

Eligibility Criteria

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

You may qualify if:

• Has histological confirmation of NASH
• 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.

You may not qualify if:

• Has presence of cirrhosis on liver biopsy
• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (180)

Adobe Clinical Research, LLC ( Site 2644)

Tucson, Arizona, 85712, United States

Location

Arizona Liver Health ( Site 9026)

Tucson, Arizona, 85712, United States

Location

Del Sol Research Management ( Site 2674)

Tucson, Arizona, 85715, United States

Location

Arkansas Gastroenterology - North Little Rock ( Site 9015)

North Little Rock, Arkansas, 72117, United States

Location

Hope Clinical Research, Inc. ( Site 2601)

Canoga Park, California, 91303, United States

Location

Velocity Clinical Research, Huntington Park ( Site 9022)

Huntington Park, California, 90255, United States

Location

UCSD - Altman Clinical and Translational Research Institute -UC San Diego NAFLD Research Center ( Si

La Jolla, California, 92037, United States

Location

Ruane Clinical Research Group, Inc ( Site 9014)

Los Angeles, California, 90036, United States

Location

Velocity Clinical Research, Westlake ( Site 9013)

Los Angeles, California, 90057, United States

Location

Catalina Research Institute, LLC ( Site 2643)

Montclair, California, 91763, United States

Location

Velocity Clinical Research, Panorama City ( Site 9001)

Panorama City, California, 91402, United States

Location

California Liver Research Institute ( Site 9025)

Pasadena, California, 91105, United States

Location

Quest Clinical Research ( Site 9011)

San Francisco, California, 94115, United States

Location

Velocity Clinical Research, Santa Ana ( Site 9002)

Santa Ana, California, 92704, United States

Location

Peak Gastroenterology Associates ( Site 2645)

Colorado Springs, Colorado, 80920, United States

Location

Top Medical Research, Inc ( Site 2673)

Cutler Bay, Florida, 33189, United States

Location

Covenant Metabolic Specialists, LLC ( Site 9027)

Fort Myers, Florida, 33912, United States

Location

North Florida South Georgia Veterans Health System ( Site 2613)

Gainesville, Florida, 32608, United States

Location

Indago Research and Health Center Inc ( Site 2610)

Hialeah, Florida, 33012, United States

Location

Sweet Hope Research Specialty Inc ( Site 2660)

Hialeah, Florida, 33016, United States

Location

Genoma Research Group, Inc. ( Site 2669)

Miami, Florida, 33173, United States

Location

Floridian Clinical Research, LLC ( Site 2656)

Miami Lakes, Florida, 33016-1518, United States

Location

Ocean Blue Medical Research Center Inc ( Site 2667)

Miami Springs, Florida, 33166, United States

Location

Sensible Healthcare Llc ( Site 2607)

Ocoee, Florida, 34761, United States

Location

Synexus Research ( Site 2672)

Orlando, Florida, 32806, United States

Location

Southeast Clinical Research Center ( Site 9003)

Dalton, Georgia, 30720, United States

Location

The University of Iowa ( Site 2655)

Iowa City, Iowa, 52242, United States

Location

Legacy Clinical Solutions: Tandem Clinical Research, LLC ( Site 2650)

Marrero, Louisiana, 70072, United States

Location

The National Diabetes & Obesity Research Institute ( Site 9017)

Biloxi, Mississippi, 39532, United States

Location

Kansas City Research Institute ( Site 9018)

Kansas City, Missouri, 64131, United States

Location

Excel Clinical Research, LLC ( Site 2603)

Las Vegas, Nevada, 89109, United States

Location

Velocity Clinical Research, Syracuse ( Site 9016)

East Syracuse, New York, 13057, United States

Location

NYU Langone Health, New York ( Site 2627)

New York, New York, 10016, United States

Location

Hillmont G.I. ( Site 9019)

Flourtown, Pennsylvania, 19031, United States

Location

Regional Gastroenterology Associates of Lancaster, LTD ( Site 9020)

Lancaster, Pennsylvania, 17601, United States

Location

Regional Gastroenterology Associates of Lancaster, LTD ( Site 9004)

Wyomissing, Pennsylvania, 19610, United States

Location

Premier Medical Group ( Site 9010)

Clarksville, Tennessee, 37040, United States

Location

Texas Clinical Research Institute ( Site 2619)

Arlington, Texas, 76012, United States

Location

The Liver Institute at Methodist Dallas Medical Center ( Site 2638)

Dallas, Texas, 75203, United States

Location

DHR Health Institute for Research and Development ( Site 9006)

Edinburg, Texas, 78539, United States

Location

South Texas Research Institute ( Site 9012)

Edinburg, Texas, 78539, United States

Location

Baylor College of Medicine - Advanced Liver Therapies ( Site 2670)

Houston, Texas, 77030, United States

Location

The Crofoot Research Center, Inc. ( Site 2611)

Houston, Texas, 77098, United States

Location

Quality Research ( Site 9024)

San Antonio, Texas, 78209, United States

Location

American Research Corporation at Texas Liver Institute ( Site 2634)

San Antonio, Texas, 78215, United States

Location

Clinical Trials of Texas, LLC ( Site 2614)

San Antonio, Texas, 78229, United States

Location

Impact Research Institute ( Site 2685)

Waco, Texas, 76710, United States

Location

Virginia Commonwealth University Health System ( Site 2657)

Richmond, Virginia, 23298, United States

Location

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0010)

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Hospital Universitario Austral ( Site 0003)

Pilar, Buenos Aires, B1629AHJ, Argentina

Location

DIM Clínica Privada ( Site 0011)

Ramos Mejía, Buenos Aires, 1704, Argentina

Location

Hospital Británico de Buenos Aires ( Site 0002)

Buenos Aires, Buenos Aires F.D., 1280, Argentina

Location

Glenny Corp. S.A.-CLINICAL RESEARCH ( Site 0013)

Buenos Aires, Buenos Aires F.D., C1430CKE, Argentina

Location

Hospital Italiano de Buenos Aires-Hepatology ( Site 0014)

Ciudad de Buenos Aires, Buenos Aires F.D., C1199ABB, Argentina

Location

Hospital Provincial del Centenario ( Site 0007)

Rosario, Santa Fe Province, S2002KDS, Argentina

Location

Hospital Aleman ( Site 0009)

Buenos Aires, C1118AAT, Argentina

Location

Clinica de nefrologia urologia y enfermedades cardiovasculares ( Site 0008)

Santa Fe, S3000BPJ, Argentina

Location

Royal Prince Alfred Hospital ( Site 0102)

Camperdown, New South Wales, 2050, Australia

Location

St George Hospital ( Site 0104)

Kogarah, New South Wales, 2217, Australia

Location

Flinders Medical Centre ( Site 0107)

Bedford Park, South Australia, 5042, Australia

Location

GIRI GI Research Institute - Vancouver ( Site 0404)

Vancouver, British Columbia, V5Z 2K5, Canada

Location

University Health Network - Toronto General Hospital ( Site 0401)

Toronto, Ontario, M5G 2C4, Canada

Location

McGill University Health Centre ( Site 0400)

Montreal, Quebec, H4A 3J1, Canada

Location

Hospital San Juan de Dios de La Serena ( Site 0500)

La Serena, Coquimbo Region, 1710216, Chile

Location

Clinical Research Chile SpA ( Site 0506)

Valdivia, Los Ríos Region, 5110683, Chile

Location

Enroll SpA ( Site 0508)

Santiago, Region M. de Santiago, 7500587, Chile

Location

Pontificia Universidad Catolica de Chile ( Site 0501)

Santiago, Region M. de Santiago, 8330077, Chile

Location

Centro de Investigaciones Clinicas Vina del Mar ( Site 0502)

Viña del Mar, Región de Valparaíso, 2540488, Chile

Location

Hospital Regional de Concepcion ( Site 0505)

Concepción, Región del Biobío, 4070038, Chile

Location

Beijing YouAn Hospital, Capital Medical University ( Site 0605)

Beijing, Beijing Municipality, 100069, China

Location

Chongqing Three Gorges Central Hospital ( Site 0618)

Wanzhou District, Chongqing Municipality, 404100, China

Location

The First People's Hospital of Foshan-Infection Department ( Site 0612)

Foshan, Guangdong, 528041, China

Location

General Hospital of Ningxia Medical University ( Site 0607)

Yinchuan, Ningxia, 750004, China

Location

Xinhua Hospital Affiliated to Jiaotong University School of Medicine ( Site 0602)

Shanghai, Shanghai Municipality, 200092, China

Location

The Affiliated Hospital of Hangzhou Normal University ( Site 0600)

Hangzhou, Zhejiang, 310015, China

Location

Fundacion Santa Fe de Bogota ( Site 0705)

Bogotá, Bogota D.C., 110111, Colombia

Location

CHU de Nice Hopital de l Archet II ( Site 0800)

Nice, Alpes-Maritimes, 06202, France

Location

hopital haut leveque chu de bordeaux-Service d'Hépato-gastroentérologie ( Site 0805)

Pessac, Aquitaine, 33600, France

Location

Hopital de la Croix-Rousse ( Site 0809)

Lyon, Auvergne, 69004, France

Location

CHU Dijon Bourgogne - Hopital F. Mitterrand ( Site 0816)

Dijon, Bourgogne-Franche-Comté, 21079, France

Location

CHU Besançon ( Site 0806)

Besançon, Franche-Comte, 25000, France

Location

Centre Hospitalier et Universitaire Dupuytren ( Site 0810)

Limoges, Haute-Vienne, 87042, France

Location

Hôpital Beaujon ( Site 0804)

Clichy, Hauts-de-Seine, 92110, France

Location

C.H.U. Nancy Hopital de Brabois ( Site 0803)

Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54500, France

Location

Hôpital Claude Huriez ( Site 0811)

Lille, Nord, 59037, France

Location

Hopital Henri Mondor ( Site 0808)

Créteil, Val-de-Marne, 94000, France

Location

A.P.H. Paris, Hopital Saint Antoine ( Site 0807)

Paris, 75012, France

Location

Hopital de la Pitie Salpetriere ( Site 0813)

Paris, 75013, France

Location

Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0812)

Paris, 75679, France

Location

Universitaetsklinikum Freiburg ( Site 0446)

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Universitätsklinikum Frankfurt-Medizinische Klinik 1 ( Site 0445)

Frankfurt am Main, Hesse, 60590, Germany

Location

Johannes Gutenberg Universitat Mainz ( Site 0442)

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Universitaetsklinikum Leipzig ( Site 0447)

Leipzig, Saxony, 04103, Germany

Location

Charite Universitaetsmedizin Berlin ( Site 0443)

Berlin, 13353, Germany

Location

Hippokration University Hopsital-4th Department of Internal Medicine ( Site 3300)

Thessaloniki, Central Macedonia, 5 46 42, Greece

Location

Queen Mary Hospital ( Site 1003)

Hong Kong, 000000, Hong Kong

Location

Prince of Wales Hospital ( Site 1001)

Shatin, Hong Kong

Location

Prince of Wales Hospital ( Site 1002)

Shatin, Hong Kong

Location

Rambam Medical Center ( Site 1201)

Haifa, 3109601, Israel

Location

Carmel Medical Center ( Site 1203)

Haifa, 3436212, Israel

Location

Shaare Zedek Medical Center ( Site 1205)

Jerusalem, 9132201, Israel

Location

Rabin Medical Center ( Site 1204)

Petah Tikva, 4941492, Israel

Location

Chaim Sheba Medical Center ( Site 1200)

Ramat Gan, 5265601, Israel

Location

Maccabi Health Services - Ramat Hasharon ( Site 1206)

Ramat HaSharon, 4731001, Israel

Location

Sourasky Medical Center ( Site 1202)

Tel Aviv, 6423906, Israel

Location

IRCCS Istituto Clinico Humanitas di Rozzano ( Site 1303)

Rozzano, Lombardy, 20089, Italy

Location

A O U Policlinico di Modena ( Site 1307)

Modena, 41124, Italy

Location

Azienda Ospedaliera Policlinico Umberto I ( Site 1300)

Roma, 00161, Italy

Location

Azienda Ospedaliera Universitaria Integrata Verona ( Site 1301)

Verona, 37134, Italy

Location

Aichi Medical University Hospital ( Site 1402)

Nagakute, Aichi-ken, 480-1195, Japan

Location

Ehime University Hospital ( Site 1417)

Tōon, Ehime, 791-0295, Japan

Location

Ogaki Municipal Hospital ( Site 1409)

Ōgaki, Gifu, 503-8502, Japan

Location

Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 1404)

Sapporo, Hokkaido, 060-0033, Japan

Location

Kanazawa University Hospital ( Site 1419)

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Kagawa University Hospital ( Site 1414)

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

Kagawa Prefectural Central Hospital-liver intemal medicine ( Site 1416)

Takamatsu, Kagawa-ken, 760-0065, Japan

Location

Shinyurigaoka General Hospital ( Site 1420)

Kawasaki, Kanagawa, 215-0026, Japan

Location

Yokohama City University Hospital ( Site 1411)

Yokohama, Kanagawa, 236-0004, Japan

Location

Nara Medical University Hospital ( Site 1407)

Kashihara, Nara, 634-8522, Japan

Location

Saiseikai Suita Hospital ( Site 1403)

Suita, Osaka, 564-0013, Japan

Location

Fukui-ken Saiseikai Hospital ( Site 1410)

Fukui, 918-8503, Japan

Location

Gifu Municipal Hospital ( Site 1408)

Gifu, 500-8513, Japan

Location

Hiroshima University Hospital ( Site 1413)

Hiroshima, 7348551, Japan

Location

Kagoshima University Hospital ( Site 1418)

Kagoshima, 890-8520, Japan

Location

University Hospital, Kyoto Prefectural University of Medicine ( Site 1405)

Kyoto, 602-8566, Japan

Location

Kawasaki Medical School General Medical Center ( Site 1412)

Okayama, 700-8505, Japan

Location

Osaka Metropolitan University Hospital ( Site 1415)

Osaka, 545-8586, Japan

Location

Toranomon Hospital ( Site 1401)

Tokyo, 105-8470, Japan

Location

Hospital Kuala Lumpur-Gastroenterology Department ( Site 2701)

Kuala Lumpur, 50586, Malaysia

Location

Centro de Investigacion Medico Biologica y Terapia Avanzada SC ( Site 1511)

Guadalajara, Jalisco, 44130, Mexico

Location

Centro de Investigacion Medica de Occidente S.C. ( Site 1514)

Zapopan, Jalisco, 45116, Mexico

Location

Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 1515)

Mexico City, Mexico City, 14050, Mexico

Location

Medical Care and Research S.A. de C.V. ( Site 1506)

Mérida, Yucatán, 97070, Mexico

Location

Centro de Investigacion y Gastroenterologia SC ( Site 1503)

Mexico City, 06700, Mexico

Location

Christchurch Hospital ( Site 1602)

Christchurch, Canterbury, 8011, New Zealand

Location

Auckland Clinical Studies Limited ( Site 1600)

Auckland, 1010, New Zealand

Location

Middlemore Clinical Trials ( Site 1601)

Auckland, 2025, New Zealand

Location

Pan American Center for Oncology Trials ( Site 3102)

Rio Piedras, 00935, Puerto Rico

Location

Klinical Investigations Group ( Site 3100)

San Juan, 00909, Puerto Rico

Location

FDI Clinical Research ( Site 3101)

San Juan, 00927, Puerto Rico

Location

City Clinical Hospital named V.M.Buyanova ( Site 1922)

Moscow, Moscow, 115516, Russia

Location

Russian University of People Friendship ( Site 1907)

Moscow, Moscow, 117198, Russia

Location

Nephrology Clinic of Internal and Prof. Diseases n.a.E.M.Tareev ( Site 1906)

Moscow, Moscow, 119435, Russia

Location

Center targetnoy therapy-Gastroenterology ( Site 1918)

Moscow, Moscow, 125008, Russia

Location

Medical Rehabilitation Center ( Site 1904)

Moscow, Moscow, 125367, Russia

Location

SPb State Budgetary Institution Health Care City Policlinic 17 ( Site 1910)

Saint Petersburg, Sankt-Peterburg, 194358, Russia

Location

Scientific research center ECO-security ( Site 1920)

Saint Petersburg, Sankt-Peterburg, 196143, Russia

Location

Surgical Clinic "Parada" ( Site 1921)

Saint Petersburg, Sankt-Peterburg, 197348, Russia

Location

LLC Astarta ( Site 1912)

Saint Petersburg, Sankt-Peterburg, 199226, Russia

Location

Seoul National University Bundang Hospital-Internal Medicine ( Site 2005)

Seongnam, Kyonggi-do, 13620, South Korea

Location

Pusan National University Hospital-Internal Medicine ( Site 2010)

Busan, Pusan-Kwangyokshi, 49241, South Korea

Location

Chungang University Hospital ( Site 2007)

Dongjak-gu, Seoul, 06973, South Korea

Location

Asan Medical Center ( Site 2001)

Songpagu, Seoul, 05505, South Korea

Location

Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2006)

Incheon, 22332, South Korea

Location

Seoul National University Hospital ( Site 2003)

Seoul, 03080, South Korea

Location

Hanyang University Seoul Hospital ( Site 2002)

Seoul, 04763, South Korea

Location

Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 2008)

Seoul, 06351, South Korea

Location

Korea University Guro Hospital ( Site 2004)

Seoul, 08308, South Korea

Location

Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 2106)

Santander, Cantabria, 39005, Spain

Location

Hospital Clinico Universitario de Santiago ( Site 2104)

Santiago de Compostela, La Coruna, 15706, Spain

Location

Hospital Universitario Puerta de Hierro-Majadahonda ( Site 2100)

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario Virgen del Rocio ( Site 2105)

Seville, Sevilla, 41013, Spain

Location

Hospital Universitari Vall d Hebron ( Site 2101)

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona ( Site 2102)

Barcelona, 08036, Spain

Location

Karolinska Universitetssjukhuset Huddinge ( Site 2900)

Huddinge, Stockholm County, 141 86, Sweden

Location

Akademiska sjukhuset ( Site 2901)

Uppsala, Uppsala County, 751 85, Sweden

Location

Chiayi Christian Hospital ( Site 2308)

Chiayi City, Chiayi, 600, Taiwan

Location

Chung Shan Medical University Hospital ( Site 2307)

Taichung, Taichung, 402, Taiwan

Location

Chang Gung Memorial Hospital - Linkou Branch ( Site 2305)

Taoyuan, Taoyuan, 333, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2302)

Kaohsiung City, 807, Taiwan

Location

Taichung Veterans General Hospital ( Site 2306)

Taichung, 407, Taiwan

Location

National Cheng Kung University Hospital ( Site 2304)

Tainan, 704, Taiwan

Location

National Taiwan University Hospital ( Site 2301)

Taipei, 100, Taiwan

Location

Hacettepe Uni. Ic Hastaliklari Anabilim Dali, Nefroloji BD ( Site 2403)

Ankara, 06230, Turkey (Türkiye)

Location

Gazi University Medical Faculty ( Site 2405)

Ankara, 06560, Turkey (Türkiye)

Location

Ankara University Cebeci Research and Application Hospital ( Site 2406)

Ankara, 54290, Turkey (Türkiye)

Location

Bezmialem Vakf Üniversitesi-Gastroenterology ( Site 2402)

Istanbul, 34093, Turkey (Türkiye)

Location

Istanbul Universitesi Tip Fakultesi Hastanesi ( Site 2401)

Istanbul, 34093, Turkey (Türkiye)

Location

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 2400)

Istanbul, 34899, Turkey (Türkiye)

Location

Ege University Medical Faculty ( Site 2404)

Izmir, 35100, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 39984821 RESULT

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director, MD

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 12, 2020
• Study Start: November 11, 2020
• Primary Completion: April 13, 2023
• Study Completion: April 13, 2023
• Last Updated: July 17, 2025
• Results First Posted: April 29, 2024

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

ME (5); CO (1); DE (5); HK (3); IL (7); CA (3); JP (19); GR (1); AU (3); PR (3); SE (2); NZ (3); ES (6); TU (7); IT (4); AR (9); KR (9); US (48); CN (6); MY (1); RU (9); TW (7); CL (6); FR (13)