Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

Inclusion Criteria

• •Adults with chronic liver disease due to NASH defined as macrovesicular steatosis involving \> 5% of hepatocytes on a liver biopsy with associated lobular inflammation
• •Stage 3-4 fibrosis by Ishak score on a liver biopsy
• •Exclusion of other causes of liver disease including viral hepatitis and alcoholic liver disease
• •Must have aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 10 x Central Laboratory Upper Limit of Normal (clULN)
• •Must have serum creatinine \< 2.0 mg/dL
• •A negative serum pregnancy test is required for females of childbearing potential
• •All sexually active females of childbearing potential must agree to use a protocol recommended method of contraception during intercourse throughout the study and for 90 days following the last dose of study medication
• •Lactating females must agree to discontinue nursing before starting study treatment
• •Males, if not vasectomized, are required to use barrier contraception (condom plus spermicide) during heterosexual intercourse from the screening through the study completion and for 90 days following the last dose of study drug.