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NCT04897594 · ClinicalTrials.gov registry record · Phase 1
AVIATION Study: A Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TERN-201 in Patients With Non-Cirrhotic Non-Alcoholic Steatohepatitis
A Phase 1 study, sponsored by Terns.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT04897594: Completed Phase 1 study, sponsored by Terns.
NCT04897594 is a Phase 1 study that has completed, run by Terns. The registered enrollment target is 52 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04897594, a Phase 1 study, has completed, sponsored by Terns.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study 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.
Primary Outcome
Number of patients experiencing at least 1 TEAE (Safety Analysis Set). TEAE = Treatment-emergent adverse event. Please see additional details in Adverse Events section.
Interventions
- OTHER Placebo
- DRUG TERN-201
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2021-05-20 |
| Est. Completion | 2022-09-02 |
| Phase | Phase 1 |
What the finished NCT04897594 record still lists
NCT04897594 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (13% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04897594 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04897594 about?
NCT04897594 is a clinical study titled "AVIATION Study: A Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TERN-201 in Patients With Non-Cirrhotic Non-Alcoholic Steatohepatitis". 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.
What is the current status of trial NCT04897594?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2021-05-20. Estimated completion is 2022-09-02.
What interventions are being tested in trial NCT04897594?
The interventions under investigation include: Placebo (OTHER), TERN-201 (DRUG).
Who is sponsoring clinical trial NCT04897594?
This trial is sponsored by Terns, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04897594's enrollment target sits among peer trials
52 956th of 2000 higher than 1,032 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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