Summary:
A clinical research study for individuals 21 to 75 years of age with compensated cirrhosis from nonalcoholic steatohepatitis (NASH).
The purpose of the NASH Study is to evaluate the safety and effectiveness of a study drug in patients with compensated cirrhosis due to NASH. The study drug is an intravenous (IV) infusion that is being investigated to see if it improves liver fibrosis associated with compensated cirrhosis due to NASH.
Participation in this study consists of approximately 19 study visits over about a one-year period. Individuals will be evaluated to determine their eligibility to participate in this study. Each person who qualifies will receive the study drug or placebo (an inactive drug), as well as study-related medical exams and study-related laboratory tests, all at no cost.
Talk to your doctor to see if this study is a good potential option for you.
Eligible participants must:
- Be 21 to 75 years of age
- Have a confirmed diagnosis of NASH and stage 4 liver fibrosis
- Not have a previous or planned liver transplant
Other protocol-defined inclusion and exclusion criteria apply.