Status:
COMPLETED
AVIATION Study: A Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TERN-201 in Patients With Non-Cirrhotic Non-Alcoholic Steatohepatitis
Lead Sponsor:
Terns, Inc.
Conditions:
NASH - Nonalcoholic Steatohepatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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...
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-cT1 value\> 800 ms
- 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
- Weight loss of \> 5% total body weight within 3 months prior to Screening
- Note: Other protocol-defined inclusion/exclusion criteria could apply.
Key Trial Info
Start Date :
May 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04897594
Start Date
May 20 2021
End Date
September 2 2022
Last Update
June 7 2024
Active Locations (11)
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1
Terns Clinical Study Site 1018
Tucson, Arizona, United States, 85712
2
Terns Clinical Study Site 1024
Tucson, Arizona, United States, 85712
3
Terns Clinical Study Site 1004
Coronado, California, United States, 92117
4
Terns Clinical Study Site 1039
Los Angeles, California, United States, 90048