At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 101 enrolled
Drug / intervention
TERN-101 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 5
- ✓Age 18–75 years
- ✓Overweight or obese: BMI ≥25 kg/m²
- ✓Presumed NASH confirmed by clinical characteristics or prior biopsy
- ✓Elevated ALT: ≥43 IU/L (men), ≥28 IU/L (women)
Key exclusion· 7
- ✕Other chronic liver diseases besides NAFLD
- ✕Cirrhosis, hepatic decompensation, or severe liver impairment
- ✕History of liver transplant or current listing
- ✕Weight loss >5% within 3 months prior to screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2a Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Orally Administered TERN-101 Tablets in Adult Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
In Brief
A Phase 2 clinical trial evaluating TERN-101 and Placebo for NASH - Nonalcoholic Steatohepatitis. Completed, enrolled 101 participants across 31 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNASH - Nonalcoholic Steatohepatitis
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedMar 2020
Enrollment StartJun 2020
Primary CompletionMay 2021
TodayJul 2026
First PostedMar 31, 2020
Enrollment StartJun 18, 2020
Primary CompletionMay 19, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.3 years ago
Interventions
TERN-101drug
Investigational drug
Placeboother
Matching placebo