LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)

Inclusion Criteria: * Male or female, 18 to 75 years of age * Overweight or obese with a body mass index (BMI) ≥ 25 kg/m2 * Presumed NASH based on clinical characteristics or prior liver biopsy * ALT ≥ 43 IU/L for men and ≥ 28 IU/L for women * MRI PDFF liver fat content ≥ 10 % * Written informed consent Exclusion Criteria: * History or clinical evidence of chronic liver diseases other than NAFLD * History or clinical evidence of cirrhosis, hepatic decompensation or other severe liver impairment * History of liver transplant, or current placement on a liver transplant list * Total bilirubin \> 1.2 mg/dL * Albumin \< 3.5 g/dL * INR \> 1.1 * AST or ALT \> 5 x ULN * ALP \> 156 IU/L * Platelet count \< 150,000 /mm3 * eGFR \< 60 mL/min/1.73m2 * Weight loss \> 5% within past 3 months prior to Screening * Uncontrolled diabetes * Uncontrolled hyperlipidemia * Active COVID-19 infection * Other protocol-defined inclusion/exclusion criteria could apply