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

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.