A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)
Non-alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic, NAFLD
About this trial
This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease
Eligibility Criteria
Inclusion Criteria: Histological confirmation of NASH, defined as NAFLD Activity Score (NAS) ≥4 with a score ≥1 point in each component (steatosis, ballooning, and lobular inflammation) AND NASH clinical research network (CRN) fibrosis score of Stage 2 or 3 No history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM with an A1C ≤9% that is controlled by diet or stable doses of antihyperglycemic agents (AHAs) Participants in South Korea are eligible between the ages of 19 to 80 years of age (inclusive) Exclusion Criteria: History of liver disease other than NASH History or evidence of cirrhosis History of pancreatitis History of Type 1 diabetes mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatectomy History of a bariatric surgical procedure ≤5 years before study entry, or a known clinically significant gastric emptying abnormality Has significant systemic or major illnesses, including recent events (≤6 months before study entry) of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack
Sites / Locations
- Del Sol Research Management, LLC ( Site 3211)Recruiting
- Velocity Clinical Research, Gardena ( Site 3225)Recruiting
- Velocity Clinical Research, Huntington Park ( Site 3217)Recruiting
- Velocity Clinical Research, San Diego ( Site 3226)Recruiting
- Velocity Clinical Research, Westlake ( Site 3216)Recruiting
- Velocity Clinical Research, Panorama City ( Site 3214)Recruiting
- California Liver Research Institute ( Site 3232)Recruiting
- Clinical Trials Research ( Site 3230)Recruiting
- Top Medical Research ( Site 3209)Recruiting
- Covenant Metabolic Specialists, LLC ( Site 3231)Recruiting
- Velocity Clinical Research, Hallandale Beach ( Site 3241)Recruiting
- Indago Research & Health Center, Inc ( Site 3207)Recruiting
- Sweet Hope Research Specialty, Inc-Research ( Site 3200)Recruiting
- Floridian Clinical Research, LLC ( Site 3203)Recruiting
- Genoma Research Group ( Site 3242)Recruiting
- Eagle Clinical Research ( Site 3233)Recruiting
- University of Iowa ( Site 3213)Recruiting
- Velocity Clinical Research, Syracuse ( Site 3227)Recruiting
- New York Gastroenterology Associates ( Site 3252)Recruiting
- Velocity Clinical Research, Cincinnati ( Site 3237)Recruiting
- Velocity Clinical Research, Providence ( Site 3222)Recruiting
- Velocity Clinical Research, Dallas ( Site 3220)Recruiting
- American Research Corporation ( Site 3202)Recruiting
- Velocity Clinical Research, Salt Lake City ( Site 3223)Recruiting
- Enroll SpA ( Site 0501)Recruiting
- CECIM ( Site 0500)Recruiting
- centre hospitalier lyon sud-Endocrinologie, Diabète et Nutrition ( Site 0906)Recruiting
- Prince of Wales Hospital ( Site 1000)Recruiting
- Rambam Health Care Campus ( Site 1304)Recruiting
- Carmel Hospital ( Site 1305)Recruiting
- Rabin Medical Center ( Site 1301)Recruiting
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 1403)Recruiting
- Ehime University Hospital ( Site 1509)Recruiting
- Kurume University Hospital ( Site 1504)Recruiting
- Ogaki Municipal Hospital ( Site 1511)Recruiting
- Sapporo Kosei General Hospital ( Site 1521)Recruiting
- Kagawa Prefectural Central Hospital ( Site 1514)Recruiting
- Shinyurigaoka General Hospital ( Site 1518)Recruiting
- St. Marianna University Hospital ( Site 1516)Recruiting
- Yokohama City University Hospital ( Site 1505)Recruiting
- Shinshu University Hospital ( Site 1512)Recruiting
- Nara Medical University Hospital ( Site 1513)Recruiting
- Osaka Saiseikai Suita Hospital ( Site 1503)Recruiting
- Fukuiken Saiseikai Hospital ( Site 1507)Recruiting
- Gifu Municipal Hospital ( Site 1506)Recruiting
- University Hospital,Kyoto Prefectural University of Medicine ( Site 1519)Recruiting
- Kawasaki Medical School General Medical Center ( Site 1508)Recruiting
- Osaka Metropolitan University Hospital ( Site 1520)Recruiting
- Saga University Hospital ( Site 1510)Recruiting
- Japanese Red Cross Musashino Hospital ( Site 1517)Recruiting
- Boramae Medical Center-Internal Medicine ( Site 2403)Recruiting
- Inha University Hospital-Gastroenterolgy/Hepatology ( Site 2402)Recruiting
- Severance Hospital, Yonsei University Health System ( Site 2401)Recruiting
- Samsung Medical Center-Gastroenterology/Internal Medicine ( Site 2400)Recruiting
- ISIS CLINICAL RESEARCH CENTER ( Site 2006)Recruiting
- Pan American Center for Oncology Trials ( Site 2000)Recruiting
- Klinical Investigations Group-Clinical Research ( Site 2001)Recruiting
- Latin Clinical Trial Center ( Site 2004)Recruiting
- Hospital Universitario Marqués de Valdecilla-Gastroenterology and Hepatology ( Site 2505)Recruiting
- Hospital General de Tomelloso-Aparato Digestivo ( Site 2514)Recruiting
- CHUAC-Complejo Hospitalario Universitario A Coruña-Endocrinología ( Site 2511)Recruiting
- Hospital Universitario Ramón y Cajal ( Site 2508)Recruiting
- Hospital Universitari Vall d'Hebron-Liver Unit - Department of Internal Medicine ( Site 2507)Recruiting
- Hospital Universitario La Paz-HEPATOLOGIA ( Site 2509)Recruiting
- HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO-Unidad de Ensayos Clínicos de Aparato Digestivo ( Site 2504)Recruiting
- Changhua Christian Hospital-Endocrinology and metabolism ( Site 2704)Recruiting
- Chiayi Christian Hospital ( Site 2707)Recruiting
- Taichung Veterans General Hospital ( Site 2703)Recruiting
- National Cheng Kung University Hospital-Liver Research team of National Cheng Kung University HospiRecruiting
- National Taiwan University Hospital-Internal Medicine ( Site 2700)Recruiting
- Taipei Veterans General Hospital-Division of Gastroenterology & Hepatology, Department of Medicine (Recruiting
- Chang Gung Medical Foundation-Linkou Branch ( Site 2702)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Placebo Comparator
Active Comparator
Efinopegdutide 4mg
Efinopegdutide 7mg
Efinopegdutide 10mg
Placebo
Semaglutide 2.4 mg
Efinopegdutide administered by subcutaneous (SC) injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks and 4mg for 48 weeks.
Efinopegdutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, and 7 mg for 44 weeks.
Efinopegdutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 2 mg for 4 weeks, 4 mg for 4 weeks, 7 mg for 4 weeks, and 10 mg for 40 weeks.
Placebo administered by SC injection once weekly for 52 weeks
Semaglutide administered by SC injection once weekly for 52 weeks in a dose-escalation regimen of 0.25 mg for 4 weeks, 0.5 mg for 4 weeks, 1.0 mg for 4 weeks, 1.7 mg for 4 weeks, and 2.4 mg for 36 weeks.