At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 52 enrolled
Drug / intervention
TERN-201 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled, Proof of Concept, Adaptive, Phase 1b Clinical Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Orally Administered TERN-201 in Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
In Brief
A Phase 1 clinical trial evaluating TERN-201 and Placebo for NASH - Nonalcoholic Steatohepatitis. Completed, enrolled 52 participants across 11 sites.
Detailed 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 with non-cirrhotic NASH.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNASH - Nonalcoholic Steatohepatitis
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20222023202420252026
Enrollment StartMay 2021
First PostedMay 2021
Primary CompletionSep 2022
TodayJul 2026
First PostedMay 21, 2021
Enrollment StartMay 20, 2021
Primary CompletionSep 2, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.1 years ago
Interventions
TERN-201drug
Investigational drug
Placeboother
Matching placebo