Clinical Trial Details

Trial ID: L0038
Source ID: NCT04944992
Associated Drug: Semaglutide
Title: A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001)
Acronym: --
Status: Active, not recruiting
Study Results: No Results Available
Results: --
Conditions: Nonalcoholic Fatty Liver Disease|Nonalcoholic Steatohepatitis
Interventions: Drug: Efinopegdutide 20 mg/mL|Drug: Semaglutide 1.34 mg/mL
Outcome Measures: Mean Relative Reduction from Baseline in Liver Fat Content (LFC) Measured by Magnetic Resonance Imaging-Estimated Proton Density Fat Fraction (MRI-PDFF), Evaluated by Blinded Independent Central Review (BICR) After 24 weeks|Number of Participants Who Experience an Adverse Event|Number of Participants Who Discontinue Study Intervention Due to an Adverse Event|Mean Absolute Reduction from Baseline in LFC Measured by MRI-PDFF (evaluated by BICR) After 24 Weeks|Mean Percent Change from Baseline in Body Weight After 24 weeks|Mean Change from Baseline in Total Cholesterol After 24 Weeks|Mean Change from Baseline in Non-High Density Lipoprotein-Cholesterol (non-HDL-C) After 24 Weeks|Mean Change from Baseline in High Density Lipoprotein-Cholesterol (HDL-C) After 24 Weeks|Mean Change from Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) After 24 weeks|Mean Change from Baseline in Triglycerides (TG) After 24 Weeks|Mean Change from Baseline in Apolipoprotein B (apoB) After 24 Weeks
Sponsor/Collaborators: Merck Sharp & Dohme Corp.
Gender: All
Age: 18 Years to 70 Years ?? (Adult, Older Adult)
Phases: Phase 2
Enrollment: 130
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
Start Date: August 4, 2021
Completion Date: October 4, 2022
Results First Posted: --
Last Update Posted: March 4, 2022
Locations: Catalina Research Institute, LLC ( Site 1939), Montclair, California, United States|Sweet Hope Research Specialty, Inc ( Site 1902), Hialeah, Florida, United States|Floridian Clinical Research, LLC ( Site 1950), Miami Lakes, Florida, United States|Sensible Healthcare, LLC ( Site 1903), Ocoee, Florida, United States|Lucas Research, Inc ( Site 1930), Morehead City, North Carolina, United States|Texas Clinical Research Institute ( Site 1910), Arlington, Texas, United States|Baylor College of Medicine-Advanced Liver Therapies ( Site 1960), Houston, Texas, United States|American Research Corporation at Texas Liver Institute ( Site 1920), San Antonio, Texas, United States|Clinical Trials of Texas, Inc. ( Site 1906), San Antonio, Texas, United States|CIPREC-Laboratorio ( Site 0104), Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina|Instituto de Investigaciones Cl??nicas Mar del Plata ( Site 0101), Mar del Plata, Buenos Aires, Argentina|Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0105), Ciudad Autonoma de Buenos Aires, Caba, Argentina|IDIM - Instituto de Diagn??stico e Investigaciones Metab??licas ( Site 0107), Buenos Aires, Argentina|Westmead Hospital-Gastroenterology & Hepatology ( Site 0204), Westmead, New South Wales, Australia|Flinders Medical Centre-Hepatology and Liver Transplant Medicine ( Site 0201), Bedford Park, South Australia, Australia|Heritage Medical Research Clinic ( Site 0302), Calgary, Alberta, Canada|Centre Hospitalier Universitaire Dijon Bourgogne - H??pital F-ENDOCRINOLOGY-DIABETOLOGY ( Site 0401), Dijon, Cote-d Or, France|centre hospitalier lyon sud-Endocrinologie, Diab??te et Nutrition ( Site 0402), Pierre-B??nite, Rhone, France|Rambam Health Care Campus-Liver disease unit ( Site 0704), Haifa, Israel|Carmel Hospital-Liver Unit ( Site 0705), Haifa, Israel|Shaare Zedek Medical Center-Liver Unit ( Site 0703), Jerusalem, Israel|Rabin Medical Center ( Site 0701), Petah-Tikva, Israel|Sheba Medical Center-The Liver Diseases Center ( Site 0700), Ramat Gan, Israel|Sourasky Medical Center-Gastroenterology and Liver Disease ( Site 0702), Tel Aviv, Israel|Policlinico Umberto I ( Site 0801), Roma, Lazio, Italy|Fondazione IRCCS C?? Granda Ospedale Maggiore Policlinico ( Site 0805), Milano, Lombardia, Italy|Humanitas-Medicina interna ed Epatologia ( Site 0800), Rozzano, Lombardia, Italy|Azienda Ospedaliero Universitaria ( Site 0803), Modena, Italy|Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Roma-Medicine ( Site 0804), Verona, Italy|Soon Chun Hyang University Bucheon Hospital ( Site 1304), Bucheon, Kyonggi-do, Korea, Republic of|Inha University Hospital-Gastroenterolgy/Hepatology ( Site 1303), Incheon, Korea, Republic of|Severance Hospital, Yonsei University Health System ( Site 1305), Seoul, Korea, Republic of|Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 1302), Seoul, Korea, Republic of|Korea University Guro Hospital ( Site 1300), Seoul, Korea, Republic of|Medica Sur-Clinica de Enfermedades Digestivas y Obesidad ( Site 0908), Mexico City, Distrito Federal, Mexico|Ark?? Estudios Cl??nicos S.A. de C.V.-Gastroenterology-Hepatology ( Site 0906), Mexico, Distrito Federal, Mexico|Avix Investigaci??n Clinica, S.C. ( Site 0907), Monterrey, Nuevo Leon, Mexico|Centro Multidisciplinario para el Desarrollo Especializado de la Investigacion Clinica en Yucatan (, Merida, Yucatan, Mexico|Centro de Investigaci??n y Gastroenterolog??a ( Site 0902), Cuauht??moc, Mexico|Christchurch Hospital-Gastroenterology Research ( Site 1002), Christchurch, Canterbury, New Zealand|Auckland City Hospital-Liver Research Unit ( Site 1003), Auckland, New Zealand|Middlemore Clinical Trials ( Site 1000), Auckland, New Zealand|Nasz Lekarz Przychodnie Medyczne ( Site 1105), Torun, Kujawsko-pomorskie, Poland|Centrum Medyczne Pratia Warszawa ( Site 1107), Warsaw, Mazowieckie, Poland|Clinical Medical Research ( Site 1101), Katowice, Slaskie, Poland|ID Clinic ( Site 1100), Mysowice, Slaskie, Poland|New Technologies of Medicine Clinic ( Site 1204), Dzerzhinskiy, Moskovskaya Oblast, Russian Federation|Center targetnoy therapy ( Site 1203), Moscow, Moskva, Russian Federation|Saint Petersburg City Polyclinic 117-endocrinology department ( Site 1201), Saint Petersburg, Sankt-Peterburg, Russian Federation|Astarta Clinic ( Site 1202), Saint-Petersburg, Sankt-Peterburg, Russian Federation|Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 1405), Malaga, Andalucia, Spain|CHUS - Hospital Clinico Universitario ( Site 1403), Santiago de Compostela, La Coruna, Spain|Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 1400), Barcelona, Spain|HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Gastroenterologia y Hepatologia ( Site 1402), Madrid, Spain|HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos Cl??nicos de Aparato Digestivo ( Site 1404), Sevilla, Spain|NATIONAL CHENG-KUNG UNI. HOSP.-Liver Research team of National Cheng Kung University Hospital ( Site, Tainan, Taiwan|National Taiwan University Hospital ( Site 1501), Taipei, Taiwan|Chang Gung Medical Foundation-Linkou Branch-Division of hepatology, department of gastroenterology (, Taoyuan, Taiwan|Dokuz Eyl??l ??niversitesi-Endocrinology and Met. ( Site 1610), Bal??ova, Izmir, Turkey|Ankara University Department of Hematology, Clinical Research Unit ( Site 1603), Ankara, Turkey|Hacettepe Universitesi-internal diseases ( Site 1602), Ankara, Turkey|Gazi Universitesi-gastroenterology ( Site 1605), Ankara, Turkey|Bezmialem Vakf ??niversitesi-Gastroenterology ( Site 1606), Istanbul, Turkey|Istanbul University Capa Campus-Gastroenterology ( Site 1604), Istanbul, Turkey|Ukrainian Research Institute of Therapy ( Site 1704), Kharkiv, Kharkivska Oblast, Ukraine|L.T. Mala National Institute of Therapy of NAMS of Ukraine-Department of Aging Studies and Prevent, Kharkiv, Kharkivska Oblast, Ukraine|Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho ( Site 1710), Poltava, Poltavska Oblast, Ukraine|Communal Non-profit Enterprise "City Hospital #6" of Zaporizhzhia City Council-Therapy department (, Zaporizhia, Zaporizka Oblast, Ukraine|Adonis Plus-Outpatient department ( Site 1701), Kyiv, Ukraine
URL: https://ClinicalTrials.gov/show/NCT04944992

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D327 Semaglutide Chemical drug DB13928 GLP1R agonist Antidiabetic drug 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