LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
NCT ID: NCT04328077
Last Updated: 2022-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
101 participants
INTERVENTIONAL
2020-06-18
2021-05-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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TERN-101 dose level 1
Orally administered.
TERN-101
Investigational drug
TERN-101 dose level 2
Orally administered.
TERN-101
Investigational drug
TERN-101 dose level 3
Orally administered.
TERN-101
Investigational drug
Placebo
Orally administered.
Placebo
Matching placebo
Interventions
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TERN-101
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 PDFF liver fat content ≥ 10 %
* 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
* 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
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 1017
Chandler, Arizona, United States
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 1035
Fresno, California, United States
Terns Clinical Study Site 1013
La Jolla, California, United States
Terns Clinical Study Site 1016
Los Angeles, California, United States
Terns Clinical Study Site 1008
Montclair, California, United States
Terns Clinical Study Site 1001
Panorama City, California, United States
Terns Clinical Study Site 1012
Gainesville, Florida, United States
Terns Clinical Study Site 1007
Hialeah, Florida, United States
Terns Clinical Study Site 1028
Hialeah, Florida, United States
Terns Clinical Study Site 1009
Miami, Florida, United States
Terns Clinical Study Site 1033
Orlando, Florida, United States
Terns Clinical Study Site 1032
Indianapolis, Indiana, United States
Terns Clinical Study Site 1010
Bastrop, Louisiana, United States
Terns Clinical Study Site 1037
New Orleans, Louisiana, United States
Terns Clinical Study Site 1023
Shreveport, Louisiana, United States
Terns Clinical Study Site 1002
Baltimore, Maryland, United States
Terns Clinical Study Site 1011
Boston, Massachusetts, United States
Terns Clinical Study Site 1038
Florham Park, New Jersey, United States
Terns Clinical Study Site 1027
Durham, North Carolina, United States
Terns Clinical Study Site 1014
Hermitage, Tennessee, United States
Terns Clinical Study Site 1005
Arlington, Texas, United States
Terns Clinical Study Site 1025
Georgetown, Texas, United States
Terns Clinical Study Site 1021
Houston, Texas, United States
Terns Clinical Study Site 1029
Houston, Texas, 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
Terns Clinical Study Site 1022
Seattle, Washington, 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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TERN101-2001
Identifier Type: -
Identifier Source: org_study_id
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