Phase 2b Study of Efinopegdutide (MK-6024) in Adults with Precirrhotic Nonalcoholic Steatohepatitis
- Conditions
- onalcoholic Steatohepatitis
- Registration Number
- JPRN-jRCT2031230187
- Lead Sponsor
- Tanaka Yoshiyuki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
1)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
2)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)
3)Participants in South Korea are eligible between the ages of 19 to 80 years of age (inclusive)
1)History of liver disease other than NASH
2)History or evidence of cirrhosis
3)History of pancreatitis
4)History of Type 1 diabetes mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatectomy
5)History of a bariatric surgical procedure <=5 years before study entry, or a known clinically significant gastric emptying abnormality
6)Major illnesses less than 6 months before starting the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method