LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Interventions
- Other: Placebo
- Registration Number
- NCT04328077
- Lead Sponsor
- Terns, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 101
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TERN-101 dose level 1 TERN-101 Orally administered. TERN-101 dose level 2 TERN-101 Orally administered. TERN-101 dose level 3 TERN-101 Orally administered. Placebo Placebo Orally administered.
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events for TERN-101 Versus Placebo 16 weeks
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline in ALT Outcome Measure 12 weeks Plasma Concentration of TERN-101 - Cmax 12 Weeks (0-72 hours post dose) Maximum observed concentration
Plasma Concentration of TERN-101 - AUC 0-24 12 weeks (0-24 hours post dose) Area under the curve
Plasma Concentration of TERN-101 - Tmax 12 Weeks (0-72 hours post dose) Time to reach maximum measured plasma concentration
Plasma Concentration of TERN-101 - t1/2 12 Weeks (0-72 hours post dose) Determination of half-life
Trial Locations
- Locations (31)
Terns Clinical Study Site 1002
🇺🇸Baltimore, Maryland, United States
Terns Clinical Study Site 1028
🇺🇸Hialeah, Florida, United States
Terns Clinical Study Site 1007
🇺🇸Hialeah, Florida, United States
Terns Clinical Study Site 1005
🇺🇸Arlington, Texas, United States
Terns Clinical Study Site 1009
🇺🇸Miami, Florida, United States
Terns Clinical Study Site 1032
🇺🇸Indianapolis, Indiana, United States
Terns Clinical Study Site 1008
🇺🇸Montclair, California, United States
Terns Clinical Study Site 1010
🇺🇸Bastrop, Louisiana, United States
Terns Clinical Study Site 1023
🇺🇸Shreveport, Louisiana, United States
Terns Clinical Study Site 1014
🇺🇸Hermitage, Tennessee, 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 1003
🇺🇸San Antonio, Texas, United States
Terns Clinical Study Site 1019
🇺🇸San Antonio, Texas, United States
Terns Clinical Study Site 1018
🇺🇸Tucson, Arizona, United States
Terns Clinical Study Site 1017
🇺🇸Chandler, Arizona, 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 1001
🇺🇸Panorama City, California, 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 1022
🇺🇸Seattle, Washington, United States
Terns Clinical Study Site 1024
🇺🇸Tucson, Arizona, United States
Terns Clinical Study Site 1004
🇺🇸Coronado, California, United States
Terns Clinical Study Site 1016
🇺🇸Los Angeles, California, United States
Terns Clinical Study Site 1011
🇺🇸Boston, Massachusetts, United States
Terns Clinical Study Site 1012
🇺🇸Gainesville, Florida, United States
Terns Clinical Study Site 1033
🇺🇸Orlando, Florida, United States
Terns Clinical Study Site 1037
🇺🇸New Orleans, Louisiana, United States