AVIATION Study: A Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TERN-201 in Patients With Non-Cirrhotic Non-Alcoholic Steatohepatitis

• Status: Active, not recruiting
• Trial end date: 2022-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 1b multi-center, randomized, double-blind, dose-ranging, placebo-controlled, adaptive study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) of TERN-201 in patients with non-cirrhotic NASH.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Terns, Inc.

Criteria

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-cT1 value> 800 ms

• 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

• Weight loss of > 5% total body weight within 3 months prior to Screening

Note: Other protocol-defined inclusion/exclusion criteria that apply