Primary Outcome Measures:
- Improvement of NAS score with no concurrent worsening of fibrosis stage [ Time Frame: Year 1 ] [ Designated as safety issue: No ]Defined by a minimum 2-point improvement in NAS with at least a 1-point improvement in more than 1 category
Secondary Outcome Measures:
- Resolution of NASH with no concurrent worsening of fibrosis stage [ Time Frame: Year 2 ] [ Designated as safety issue: No ]
Other Outcome Measures:
- Resolution of NASH with no concurrent worsening of fibrosis stage [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
- Improvement of NAS score with no concurrent worsening of fibrosis stage [ Time Frame: Year 2 ] [ Designated as safety issue: No ]Defined by a minimum 2-point improvement in NAS with at least a 1-point improvement in more than 1 category
- Change in histologic fibrosis stage [ Time Frame: Years 1 and 2 ] [ Designated as safety issue: No ]NASH CRN system and Ishak
- Change in hepatic tissue fibrogenic protein [ Time Frame: Years 1 and 2 ] [ Designated as safety issue: No ]Alpha-smooth muscle actin (α-SMA)
- Change in morphometric quantitative collagen [ Time Frame: Years 1 and 2 ] [ Designated as safety issue: No ]
- Change from Baseline in noninvasive hepatic fibrosis markers [ Time Frame: Months 3, 6, 12, 15, 18, and 24 ] [ Designated as safety issue: No ]Aspartate aminotransferase (AST) to platelet count ratio index (APRI), FIB-4, hyaluronic acid, FibroTest (FibroSure), NAFLD fibrosis score (NFS) and enhanced liver fibrosis test (ELF)
- Change from Baseline in biomarkers of hepatocyte apoptosis [ Time Frame: Years 1 and 2 ] [ Designated as safety issue: No ]CK-18 caspase-cleaved and total
