Study population
liver impairment, fibrosis, NASH, hepatic decompensation, diabetes
AUTOIMMUNE LIVER DISEASE, FIBROSIS, CHRONIC LIVER DISEASE, DIABETES
Male and female patients aged ≥18 years (at the time of the screening visit) weighing between 50 and 200 kg were eligible to participate in the study. Other key inclusion criteria were (1) an adequate liver biopsy sample for evaluation by a central reader, (2) presence of NASH as demonstrated by histologic evidence, and (3) presence of fibrosis stages F2/F3 as demonstrated on a liver biopsy with evaluation by a central reader during the screening period (as per NASH clinical research network [CRN] staging criteria).Key exclusion criteria included (1) current or history of significant alcohol consumption for a period of >3 consecutive months within 1-year before screening (>20 g/d in females and >30 g/d in males), (2) uncontrolled diabetes [glycosylated hemoglobin (HbA1c) ≥9% at screening], (3) clinical evidence of hepatic decompensation or severe liver impairment, (4) previous diagnosis of other forms of chronic liver disease or a history of autoimmune liver disease, and (5) women of childbearing potential or pregnant/lactating women.