Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3

Inclusion Criteria:

- Males and non-pregnant, non-lactating females

- Evidence of NASH with fibrosis on biopsy

Exclusion Criteria:

- Cirrhosis of the liver (e.g. Brunt/Kleiner score of F4)

- Other causes of liver disease including viral hepatitis and alcoholic liver disease

- Any history of decompensated liver disease, including ascites, hepatic encephalopathy
or variceal bleeding

- History of liver transplantation

- Alcohol consumption greater than 21 oz/week for males or 14 oz/week for females (1
oz/30 mL of alcohol is present in 1 12 oz/360 mL beer, 1 4 oz/120 mL glass of wine,
and a 1 oz/30 mL measure of 40% proof alcohol)