| Outcome Measures: |
Relative change in MRI-PDFF at Week 12 in the DB phase|Adverse events (AEs) in the DB and OLE phases|Treatment emergent adverse events (TEAEs) in the DB and OLE phases|electrocardiograms (ECGs) in the DB and OLE phases|biochemistry in the DB and OLE phases|hematology in the DB and OLE phases|Absolute change in MRI-PDFF at Week 12, 26, and 52 in the DB phase|Relative change in MRI-PDFF at Week 26 and 52 in the DB phase|Proportion of subjects with a relative decrease in MRI-PDFF ??? 30% at Week 12, 26, and 52 in the DB phase|Proportion of subjects with normalization of MRI-PDFF (defined as a fat fraction of < 5%) at Week 12, 26, and 52 in the DB phase|Proportion of subjects with an absolute MRI-PDFF change > 5% at Weeks 12, 26, and 52 in the DB phase|Proportion of subjects with reversal of nonalcoholic steatohepatitis (NASH) and no worsening of hepatic fibrosis (centrally scored histology at Week 52) in the DB phase.|Proportion of subjects with improvement by at least one stage in fibrosis without worsening of NASH in the DB phase|Proportion of subjects with a 2-point improvement in NAS in the DB phase|Percent and absolute change in alanine aminotransferase (ALT) in the DB and OLE phases|Percent and absolute change in aspartate aminotransferase (AST) in the DB and OLE phases|Percent and absolute change in gamma-glutamyl transferase (GGT) in the DB and OLE phases|Percent and absolute change in total cholesterol (TC) in the DB and OLE phases|Percent and absolute change in high-density lipoprotein cholesterol (HDL-C) in the DB and OLE phases|Percent and absolute change in low-density lipoprotein cholesterol (LDL-C) in the DB and OLE phases|Percent and absolute change in non-high-density lipoprotein cholesterol (non-HDL) in the DB and OLE phases|Percent and absolute change in homeostatic model assessment of insulin resistance (HOMA-IR) in the DB and OLE phases|Percent and absolute change in high-sensitivity C-reactive protein (Hs-CRP) and fibrinogen in the DB and OLE phases
|
| Locations: |
CymaBay Research Site, Glendale, Arizona, United States|CymaBay Research Site, Tucson, Arizona, United States|CymaBay Research Site, Los Angeles, California, United States|CymaBay Research Site, Boca Raton, Florida, United States|CymaBay Research Site, Lakewood Ranch, Florida, United States|CymaBay Research Site, Flowood, Mississippi, United States|CymaBay Research Site, Clarksville, Tennessee, United States|CymaBay Research Site, Germantown, Tennessee, United States|CymaBay Research Site, Hermitage, Tennessee, United States|CymaBay Research Site, Knoxville, Tennessee, United States|CymaBay Research Site, Chandler, Texas, United States|CymaBay Research Site, Dallas, Texas, United States|CymaBay Research Site, Live Oak, Texas, United States|CymaBay Research Site, Rollingwood, Texas, United States
|
