DUET Study: A Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy and in Combination With TERN-101 in Noncirrhotic Adults With Presumed Non-Alcoholic Steatohepatitis

Key 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 diagnosed by prior biopsy and/or imaging criteria * Written informed consent Key Exclusion Criteria: * History or clinical evidence of chronic liver diseases other than NAFLD * History or known clinical evidence of cirrhosis, esophageal varices, hepatic decompensation or other severe liver impairment, * History of liver transplant, or current placement on a liver transplant list * Current diagnosis or history of pituitary or thyroid disorders - except for patients with primary hypothyroidism on a stable dose of thyroid hormone replacement therapy. * Abnormal TSH or free T4 levels * Weight loss of > 5% total body weight within 3 months prior to Screening * Uncontrolled diabetes * Uncontrolled hyperlipidemia * Unstable cardiovascular disease * Excessive alcohol consumption Other protocol-defined I/E criteria that apply.