LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)

• Status: Completed
• Trial end date: 2021-05-03
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of TERN-101 in non-cirrhotic NASH patients.

• Phase: Phase 2
• 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 PDFF liver fat content ≥ 10 %

• 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

• Total bilirubin > 1.2 mg/dL

• Albumin < 3.5 g/dL

• INR > 1.1

• AST or ALT > 5 x ULN

• ALP > 156 IU/L

• Platelet count < 150,000 /mm3

• eGFR < 60 mL/min/1.73m2

• Weight loss > 5% within past 3 months prior to Screening

• Uncontrolled diabetes

• Uncontrolled hyperlipidemia

• Active COVID-19 infection

• Other protocol-defined inclusion/exclusion criteria could apply