Clinical Trial Details

Trial ID: L0156
Source ID: NCT04583423
Associated Drug: MK-3655
Title: A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-3655-001)
Acronym: --
Status: Recruiting
Study Results: No Results Available
Results: --
Conditions: Nonalcoholic Steatohepatitis
Interventions: Drug: MK-3655|Drug: Placebo
Outcome Measures: Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 52 Weeks|Percentage of Participants Who Experienced an Adverse Event (AE)|Percentage of Participants Discontinuing Study Medication Due to an AE|Mean Percent Change from Baseline in Liver Fat Content (LFC) After 24 Weeks|Percentage of Participants With ???1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis Assessed With the NASH CRN Scoring System After 52 Weeks|Percentage of Participants With ???2 Point Improvement in the Nonalcoholic Fatty Liver Disease Activity Score (NAS) Without Worsening of Fibrosis After 52 Weeks
Sponsor/Collaborators: Merck Sharp & Dohme Corp.
Gender: All
Age: 18 Years to 80 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 328
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
Start Date: November 11, 2020
Completion Date: May 29, 2024
Results First Posted: --
Last Update Posted: March 17, 2022
Locations: Adobe Clinical Research, LLC ( Site 2644), Tucson, Arizona, United States|Del Sol Research Management ( Site 2674), Tucson, Arizona, United States|Hope Clinical Research, Inc. ( Site 2601), Canoga Park, California, United States|UCSD - Altman Clinical and Translational Research Institute -UC San Diego NAFLD Research Center ( Si, La Jolla, California, United States|Catalina Research Institute, LLC ( Site 2643), Montclair, California, United States|Peak Gastroenterology Associates ( Site 2645), Colorado Springs, Colorado, United States|Top Medical Research, Inc ( Site 2673), Cutler Bay, 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|Floridian Clinical Research, LLC ( Site 2656), Miami Lakes, Florida, United States|Ocean Blue Medical Research Center Inc ( Site 2667), Miami Springs, Florida, United States|Genoma Research Group, Inc. ( Site 2669), Miami, Florida, United States|Sensible Healthcare Llc ( Site 2607), Ocoee, Florida, United States|Synexus Research ( Site 2672), Orlando, Florida, 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|Excel Clinical Research, LLC ( Site 2603), Las Vegas, Nevada, United States|NYU Langone Health, New York ( Site 2627), New York, New York, 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|Baylor College of Medicine - Advanced Liver Therapies ( Site 2670), Houston, Texas, United States|The Crofoot Research Center, Inc. ( Site 2611), Houston, 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|Virginia Commonwealth University Health System ( Site 2657), Richmond, Virginia, United States|Instituto de Investigaciones Cl??nicas Mar del Plata ( Site 0010), Mar del Plata, Buenos Aires, Argentina|Hospital Universitario Austral ( Site 0003), Pilar, Buenos Aires, Argentina|Hospital Provincial del Centenario ( Site 0007), Rosario, Santa Fe, Argentina|Hospital Brit??nico de Buenos Aires ( Site 0002), Buenos Aires, 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|University Health Network - Toronto General Hospital ( Site 0401), Toronto, Ontario, Canada|McGill University Health Centre ( Site 0400), Montr??al, Quebec, Canada|Hospital Regional de Concepcion ( Site 0505), Concepcion, Biobio, Chile|Hospital San Juan de Dios de La Serena ( Site 0500), La Serena, Coquimbo, Chile|Clinical Research Chile SpA ( Site 0506), Valdivia, Los Rios, Chile|Pontificia Universidad Catolica de Chile ( Site 0501), Santiago, Region M. De Santiago, Chile|Centro de Investigaciones Clinicas Vina del Mar ( Site 0502), Vina del Mar, Valparaiso, Chile|Beijing YouAn Hospital, Capital Medical University ( Site 0605), Beijing, Beijing, China|The First People's Hospital of Foshan-Infection Department ( Site 0612), Foshan, Guangdong, China|General Hospital of Ningxia Medical University ( Site 0607), Yinchuan City, Ningxia, China|Xinhua Hospital Affiliated to Jiaotong University School of Medicine ( Site 0602), Shanghai, Shanghai, China|The Affiliated Hospital of Hangzhou Normal University ( Site 0600), Hangzhou, Zhejiang, China|Fundacion Santa Fe de Bogota ( Site 0705), Bogot??, Distrito Capital De Bogota, Colombia|CHU de Nice Hopital de l Archet II ( Site 0800), Nice, Alpes-Maritimes, France|hopital haut leveque chu de bordeaux-Service d'H??pato-gastroent??rologie ( 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, France|Centre Hospitalier et Universitaire Dupuytren ( Site 0810), Limoges, Haute-Vienne, France|H??pital Beaujon ( Site 0804), Clichy, Hauts-de-Seine, France|C.H.U. Nancy Hopital de Brabois ( Site 0803), Vandoeuvre les Nancy, Meurthe-et-Moselle, France|H??pital Claude Huriez ( Site 0811), Lille, Nord, France|Hopital Henri Mondor ( Site 0808), Creteil, Val-de-Marne, France|A.P.H. Paris, Hopital Saint Antoine ( Site 0807), Paris, France|Hopital de la Pitie Salpetriere ( Site 0813), Paris, France|Universitaetsklinikum Freiburg ( Site 0446), Freiburg, Baden-Wurttemberg, Germany|Universit??tsklinikum Frankfurt-Medizinische Klinik 1 ( Site 0445), Frankfurt, Hessen, Germany|Universitaetsklinikum Leipzig ( Site 0447), Leipzig, Sachsen, Germany|Charite Universitaetsmedizin Berlin ( Site 0443), Berlin, Germany|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, Lombardia, 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, Japan|Ehime University Hospital ( Site 1417), Toon, Ehime, Japan|Ogaki Municipal Hospital ( Site 1409), Ogaki, Gifu, Japan|Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital ( Site 1404), Sapporo, Hokkaido, Japan|Kagawa University Hospital ( Site 1414), Kita-gun, Kagawa, Japan|Kagawa Prefectural Central Hospital-liver intemal medicine ( Site 1416), Takamatsu, Kagawa, 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|University Hospital, Kyoto Prefectural University of Medicine ( Site 1405), Kyoto, Japan|Kawasaki Medical School General Medical Center ( Site 1412), Okayama, Japan|Osaka City University Hospital ( Site 1415), Osaka, Japan|Toranomon Hospital ( Site 1401), Tokyo, Japan|Seoul National University Bundang Hospital-Internal Medicine ( Site 2005), Seongnam, Kyonggi-do, Korea, Republic of|Chungang University Hospital ( Site 2007), Dongjak-gu, Seoul, Korea, Republic of|Asan Medical Center ( Site 2001), Songpagu, Seoul, Korea, Republic of|Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2006), Incheon, Korea, Republic of|Seoul National University Hospital ( Site 2003), Seoul, Korea, Republic of|Hanyang University Seoul Hospital ( Site 2002), Seoul, Korea, Republic of|Korea University Guro Hospital ( Site 2004), Seoul, Korea, Republic of|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|Medical Care and Research S.A. de C.V. ( Site 1506), Merida, Yucatan, 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|Fundacion de Investigacion de Diego ( Site 3101), San Juan, Puerto Rico|City Clinical Hospital named V.M.Buyanova ( Site 1922), Moscow, Moskva, Russian Federation|Russian University of People Friendship ( Site 1907), Moscow, Moskva, Russian Federation|Nephrology Clinic of Internal and Prof. Diseases n.a.E.M.Tareev ( Site 1906), Moscow, Moskva, Russian Federation|Center targetnoy therapy-Gastroenterology ( Site 1918), Moscow, Moskva, Russian Federation|Medical Rehabilitation Center ( Site 1904), Moscow, Moskva, Russian Federation|Scientific research center ECO-security ( Site 1920), Saint Petersburg, Sankt-Peterburg, Russian Federation|Surgical Clinic "Parada" ( Site 1921), Saint Petersburg, Sankt-Peterburg, Russian Federation|LLC Astarta ( Site 1912), Saint Petersburg, Sankt-Peterburg, Russian Federation|SPb State Budgetary Institution Health Care City Policlinic 17 ( Site 1910), St -Petersburg, Sankt-Peterburg, Russian Federation|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), Sevila, Sevilla, Spain|Hospital Universitari Vall d Hebron ( Site 2101), Barcelona, Spain|Hospital Clinic de Barcelona ( Site 2102), Barcelona, Spain|Akademiska sjukhuset ( Site 2901), Uppsala, Uppsala Lan, Sweden|Chang Gung Memorial Hospital - Linkou Branch ( Site 2305), Taoyuan County, Taoyuan, Taiwan|Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2302), Kaohsiung, Taiwan|Taichung Veterans General Hospital ( Site 2306), Taichung, Taiwan|National Cheng Kung University Hospital ( Site 2304), Tainan, Taiwan|National Taiwan University Hospital ( Site 2301), Taipei, Taiwan|Hacettepe Uni. Ic Hastaliklari Anabilim Dali, Nefroloji BD ( Site 2403), Ankara, Turkey|Gazi University Medical Faculty ( Site 2405), Ankara, Turkey|Ankara University Cebeci Research and Application Hospital ( Site 2406), Ankara, Turkey|Bezmialem Vakf ??niversitesi-Gastroenterology ( Site 2402), Istanbul, Turkey|Istanbul Universitesi Tip Fakultesi Hastanesi ( Site 2401), Istanbul, Turkey|Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi ( Site 2400), Istanbul, Turkey|Ege University Medical Faculty ( Site 2404), Izmir, Turkey
URL: https://ClinicalTrials.gov/show/NCT04583423

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D495 MK-3655 Chemical drug -- β-Klotho/FGFR1c agonist -- Under clinical trials Details
D094 Cysteamine Chemical drug DB00847 GSS stimulant Renal drug Under clinical trials Details
D095 Cysteamine bitartrate Chemical drug DB00847 -- -- Under clinical trials Details