Status:
COMPLETED
LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
Lead Sponsor:
Terns, Inc.
Conditions:
NASH - Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2021
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04328077
Start Date
June 18 2020
End Date
May 19 2021
Last Update
August 9 2022
Active Locations (31)
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1
Terns Clinical Study Site 1017
Chandler, Arizona, United States, 85224
2
Terns Clinical Study Site 1018
Tucson, Arizona, United States, 85712
3
Terns Clinical Study Site 1024
Tucson, Arizona, United States, 85712
4
Terns Clinical Study Site 1004
Coronado, California, United States, 92117