A Phase 2a Clinical Study to Evaluate the Safety, Efficacy, PK and PD of Orally Administered TERN-501 as Monotherapy and in Combination With TERN-101 in Noncirrhotic Adults With Presumed (NASH)

• Status: Not yet recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2a Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy as well as in Combination with TERN-101 in Noncirrhotic Adults with Presumed Non-Alcoholic Steatohepatitis (NASH)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Terns, Inc.

Criteria

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.