Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

Key Inclusion Criteria:

• Liver biopsy consistent with NASH and cirrhosis (F4 fibrosis) according to the NASHClinical Research Network (CRN) classification, in the opinion of the central reader

• Has the following laboratory parameters at the screening visit, as determined by thecentral laboratory:

• Alanine aminotransferase (ALT) ≤ 8 x upper limit of normal (ULN)

• Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as calculated by theCockcroft-Gault equation

• HbA1c ≤ 9.5% (or serum fructosamine ≤ 381 micromole (μmol) if HbA1c is unable tobe resulted)

• International normalised ratio (INR) ≤ 1.4, unless due to therapeuticanti-coagulation

• Platelet count ≥ 100,000/μL

Key Exclusion Criteria:

• Prior history of decompensated liver disease including clinical ascites, hepaticencephalopathy (HE), or variceal bleeding

• Child-Pugh (CP) score > 7, as determined at screening, unless due to therapeuticanti-coagulation

• Model for End-stage Liver Disease (MELD) score > 12, as determined at screening,unless due to therapeutic anti-coagulation

• Other causes of liver disease including, but not limited to, alcoholic liver disease,hepatitis B, hepatitis C, autoimmune disorders, drug-induced hepatotoxicity, Wilsondisease, iron overload, and alpha-1-antitrypsin deficiency, based on medical historyand/or centralized review of liver histology.

• History of liver transplantation

• Current or history of hepatocellular carcinoma (HCC) Note: Other protocol defined Inclusion/Exclusion criteria may apply.