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

Open to people ages 18-75

• 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

• 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.