18 Years to 70 Years
Accepting Healthy Volunteers?
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
- Alanine aminotransferase (ALT) ≤ 8 x upper limit of normal (ULN)
- Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as calculated by the
- HbA1c ≤ 9.5% (or serum fructosamine ≤ 381 μmol if HbA1c is unable to be resulted)
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
- 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-antitryspin 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.