Title
LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Orally Administered TERN-101 Tablets in Adult Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
Phase
Phase 2Lead Sponsor
Terns, Inc.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
NASH - Nonalcoholic SteatohepatitisIntervention/Treatment
TERN-101 ...Study Participants
101This 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.
Investigational drug
Matching placebo
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
| Event Type | Organ System | Event Term | Placebo | TERN-101 5mg | TERN-101 10mg | TERN-101 15mg |
|---|
Area under the curve
Maximum observed concentration
Time to reach maximum measured plasma concentration
Determination of half-life
