Clinical Trials

Inclusion Criteria:

• Liver biopsy consistent with NASH and bridging fibrosis (F3) and cirrhosis (F4) in the opinion of the central reader
• In participants who have never had a liver biopsy, liver stiffness by FibroScan® and Enhanced Liver Fibrosis (ELF™) Test score at Screening
• Screening laboratory parameters, as determined by the central laboratory:
  • Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min, as calculated by the Cockcroft-Gault equation
  • HbA1c ≤ 9.5%
  • Alanine aminotransferase (ALT) < 5 x Upper Limits of Normal (ULN)
  • Platelet count ≥ 125,000/μL

Exclusion Criteria:

• Prior history of decompensated liver disease including ascites, hepatic encephalopathy, or variceal bleeding
• Child-Pugh (CP) score > 6 at Screening, unless due to an alternative etiology such as Gilbert's syndrome or therapeutic anticoagulation
• Model for End-Stage Liver Disease (MELD) score > 12 at Screening, unless due to an alternate etiology such as therapeutic anticoagulation
• Other causes of liver disease based on medical history and/or centralized review of liver histology, including but not limited to: alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders (eg, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency requiring treatment
• History of liver transplantation
• Current or prior history of hepatocellular carcinoma

Note: Other protocol defined Inclusion/ Exclusion criteria may apply