Simtuzumab (SIM, GS-6624) in the Treatment of Cirrhosis Due to NASH

Key Inclusion Criteria: * Adults with cirrhosis of the liver defined as an Ishak fibrosis stage ≥ 5 * Liver biopsy consistent with NASH or cryptogenic cirrhosis * Exclusion of other causes of liver disease including viral hepatitis and alcoholic liver disease * The liver biopsy sample must be determined to be adequate for evaluation by the Central pathologist * Must have aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 10 x the upper limit of the normal range (ULN) * Must have serum creatinine \< 2.0 mg/dL * A negative serum pregnancy test is required for female subjects of childbearing potential * All sexually active female subjects of childbearing potential must agree to use a protocol recommended method of contraception during heterosexual 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 * Male subjects, 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 Key Exclusion Criteria: * Pregnant or breast feeding * Any history of hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding * Weight reduction surgery in the past 5 year * Child-Pugh-Turcotte (CPT) score \>7; Model for End-Stage Liver Disease (MELD) score \> 12 and Body Ma…