A Phase 2b Study of MK-6024 in Adults with Precirrhotic Nonalcoholic Steatohepatitis
- Conditions
- on-alcoholic steatohepatitisMedDRA version: 22.0Level: PTClassification code: 10053219Term: Non-alcoholic steatohepatitis Class: 100000004871Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- CTIS2022-502647-35-00
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 316
Histologic confirmation of NASH based on liver biopsy. Histologic criteria for study entry include: •Nonalcoholic fatty liver disease (NAFLD) Activity Score =4 with a score =1 point in each component (steatosis, ballooning, and lobular inflammation), AND •NASH Clinical Research Network (CRN) fibrosis score indicative of Stage 2 or 3., No history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM 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)
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 bariatric surgery =5 years before study participation, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method