Study: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)
Study Purpose/Objective: The primary objective of this study is to evaluate whether the study drug, SEL (selonsertib) can cause fibrosis regression and reduce associated complications in subjects with cirrhosis due to NASH.
Eligible study participants will:
– Be between the ages of 18-70 years’ old
– If a male or female of reproductive age/childbearing potential: Be willing to use contraception (birth control) throughout study participation & not planning pregnancy and/or not a currently pregnant or currently lactating female
– Diagnosis of NASH with F4 Fibrosis; as evident by a liver biopsy obtained during study screening or documented within past 12 months, that is consistent with NASH and cirrhosis (F4 fibrosis)
– Not have another cause of liver disease, such as: alcoholic liver disease, hepatitis B, hepatitis C, liver disease caused by an autoimmune disorder, or drug-induced hepatoxicity.
– Not have had a liver transplant
– Not have a history of cancer in the past 5 years (with the exception of adequately treated cervical CIS & select skin cancers)
– Not have an unstable heart condition
Study Duration: Participation in the study can last up to 252 weeks, which includes an 8-week Screening period, a 240-week treatment period and a 4-week follow-up period.
Study Medication/Investigational Product: Eligible study participants will be randomly assigned to a treatment group at a ratio of 2:2:1 (treatment of SEL 6 mg, treatment of SEL 18 mg or placebo (an inactive substance). Group assignment is done in a double-blind manner (neither the study volunteer nor the research staff or physicians will know the assignment) and stratified by the presence or absence of diabetes mellitus and by the participant’s Enhanced Liver Fibrosis (ELF) score. The study medication is a tablet to be taken by mouth and swallowed once daily.
Study Procedures: Include physical exams with the study doctors, laboratory assessments, a liver biopsy at screening (if acceptable biopsy has not occurred within the past 12 months) and at weeks 48 and 240 during the study treatment period, pregnancy tests, ECGs, and health related questionnaires
Stipend: A stipend will be provided to qualified study participants to help defray time and travel costs. Stipends are paid on a periodic basis as specifically outlined in the subject information and consent form. Note: There is no stipend for a Pre-study visit, if such a visit is scheduled.