AVIATION Study: A Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TERN-201 in Patients With Non-Cirrhotic Non-Alcoholic Steatohepatitis
NCT ID: NCT04897594
Last Updated: 2024-06-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
52 participants
INTERVENTIONAL
2021-05-20
2022-09-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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TERN-201 10mg
Orally administered
TERN-201
Investigational drug
TERN-201 20mg
Orally Administered
TERN-201
Investigational drug
Placebo
Orally administered
Placebo
Matching placebo
Interventions
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TERN-201
Investigational drug
Placebo
Matching placebo
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
75 Years
ALL
No
Sponsors
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Terns, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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Terns Clinical Study Site 1018
Tucson, Arizona, United States
Terns Clinical Study Site 1024
Tucson, Arizona, United States
Terns Clinical Study Site 1004
Coronado, California, United States
Terns Clinical Study Site 1039
Los Angeles, California, United States
Terns Clinical Study Site 1001
Panorama City, California, United States
Terns Clinical Study Site 1040
Rialto, California, United States
Terns Clinical Study Site 1013
San Diego, California, United States
Terns Clinical Study Site 1010
Bastrop, Louisiana, United States
Terns Clinical Study Site 1006
San Antonio, Texas, United States
Terns Clinical Study Site 1003
San Antonio, Texas, United States
Terns Clinical Study Site 1019
San Antonio, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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TERN201-1007
Identifier Type: -
Identifier Source: org_study_id
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