• Male and female adults ≥18 years of age with suspected or confirmed diagnosis of NASH
• ≥3 metabolic risk factors (metabolic syndrome†) and AST (>20 IU, men; >17 IU, women)
• ≥8% hepatic fat by MRI-PDFF
• NASH on biopsy: NAS ≥4 (with ≥1 in each component)
• Fibrosis stage F1B, F2, or F3
• Undergone prescreening VCTE (FibroScan) within the past 3 months that showed a CAP of 280 dB per meter or more and a LSM of 8.5 kPa or more (alternatively, a liver biopsy that was performed within 6 months before randomization)

AST, aspartate aminotransferase; BP, blood pressure; CAP, controlled attenuated parameter; F, fibrosis stage; FPG, fasting plasma glucose; IU, international unit; LSM, liver stiffness measurement; MRI-PDFF, magnetic resonance imaging-proton density fat fraction; NAFLD, nonalcoholic fatty liver disease; NAS, NAFLD activity score; NASH, nonalcoholic steatohepatitis; TG, triglycerides; VCTE, vibration-controlled transient elastography.
†Metabolic syndrome is defined based on central obesity (defined as waist circumference ≥94cm for Europid men and ≥ 80cm for Europid women, with ethnicity specific values for other groups) plus any two of the following four factors: raised TG level: >150 mg/dL (1.7 mmol/L), or specific treatment for this lipid abnormality; reduced HDL cholesterol: <40 mg/dL (1.0 mmol/L) in males and <50 mg/dL (1.3 mmol/L) in females, or specific treatment for this lipid abnormality; raised BP: systolic BP ≥130 or diastolic BP ≥85 mm Hg, or treatment of previously diagnosed hypertension; raised FPG ≥100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes (International Diabetes Federation 2006).

• Male and female adults ≥18 years of age with suspected or confirmed diagnosis of NASH
• ≥3 metabolic risk factors (metabolic syndrome†) and AST (>20 IU, men; >17 IU, women)
• ≥8% hepatic fat by MRI-PDFF
• NASH on biopsy: NAS ≥4 (with ≥1 in each component)
• Fibrosis stage F1B, F2, or F3
• Undergone prescreening VCTE (FibroScan) within the past 3 months that showed a CAP of 280 dB per meter or more and a LSM of 8.5 kPa or more (alternatively, a liver biopsy that was performed within 6 months before randomization)

AST, aspartate aminotransferase; BP, blood pressure; CAP, controlled attenuated parameter; F, fibrosis stage; FPG, fasting plasma glucose; IU, international unit; LSM, liver stiffness measurement; MRI-PDFF, magnetic resonance imaging-proton density fat fraction; NAFLD, nonalcoholic fatty liver disease; NAS, NAFLD activity score; NASH, nonalcoholic steatohepatitis; TG, triglycerides; VCTE, vibration-controlled transient elastography.
†Metabolic syndrome is defined based on central obesity (defined as waist circumference ≥94cm for Europid men and ≥ 80cm for Europid women, with ethnicity specific values for other groups) plus any two of the following four factors: raised TG level: >150 mg/dL (1.7 mmol/L), or specific treatment for this lipid abnormality; reduced HDL cholesterol: <40 mg/dL (1.0 mmol/L) in males and <50 mg/dL (1.3 mmol/L) in females, or specific treatment for this lipid abnormality; raised BP: systolic BP ≥130 or diastolic BP ≥85 mm Hg, or treatment of previously diagnosed hypertension; raised FPG ≥100 mg/dL (5.6 mmol/L), or previously diagnosed type 2 diabetes (International Diabetes Federation 2006).