Sicherheit und Wirksamkeit von Selonsertib bei Erwachsenen mit kompensierter Zirrhose infolge einer nicht-alkoholischen Steatohepatitis (NASH) (STELLAR 4)

Drug: SEL;Drug: Placebo to match SEL 6 mg;Drug: Placebo to match SEL 18 mg

Key Inclusion Criteria:

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

- Has the following laboratory parameters at the screening visit, as determined by the
central laboratory:

- Alanine aminotransferase (ALT) = 8 x upper limit of normal (ULN)

- Creatinine Clearance (CLcr) = 30 milliliter/minute (mL/min), as calculated by the
Cockcroft-Gault equation

- HbA1c = 9.5% (or serum fructosamine = 381 micromole (µmol) if HbA1c is unable to
be resulted)

- International normalised ratio (INR) = 1.4, unless due to therapeutic
anti-coagulation

- Platelet count = 100,000/µL

Key Exclusion Criteria:

- Prior history of decompensated liver disease including clinical ascites, hepatic
encephalopathy (HE), or variceal bleeding

- Child-Pugh (CP) score > 7, as determined at screening, unless due to therapeutic
anti-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, Wilson
disease, iron overload, and alpha-1-antitrypsin deficiency, based on medical history
and/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.