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NCT04669158 · ClinicalTrials.gov registry record · Phase 1
Study of Oral Idebenone to Treat Non-Alcoholic Steatohepatitis
A Phase 1 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 1
- Development phase
- 53
- Enrollment target
NCT04669158: Completed Phase 1 study, sponsored by Stanford University.
NCT04669158 is a Phase 1 study that has completed, run by Stanford University. The registered enrollment target is 53 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04669158, a Phase 1 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 53 participants
- Enrollment target
Study Summary
This is a randomized, placebo-controlled phase 1/2a study to investigate the safety and tolerability of Idebenone in patients 18 years of age or older with non-alcoholic steatohepatitis, with stage 1-3 fibrosis. As secondary end point target engagement and fibrosis improvement will be assessed.
Primary Outcome
Number of Participants with Treatment-Related Adverse Events (Assessed by CTCAE v4.0), and number of participants with abnormal Physical exams and abnormal laboratory tests results are reported.
Interventions
- DRUG Placebo
- DRUG Idebenone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2021-07-30 |
| Est. Completion | 2023-07-05 |
| Phase | Phase 1 |
What the finished NCT04669158 record still lists
NCT04669158 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04669158 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04669158 about?
NCT04669158 is a clinical study titled "Study of Oral Idebenone to Treat Non-Alcoholic Steatohepatitis". This is a randomized, placebo-controlled phase 1/2a study to investigate the safety and tolerability of Idebenone in patients 18 years of age or older with non-alcoholic steatohepatitis, with stage 1-3 fibrosis. As secondary end point target engagement and fibrosis improvement will be assessed.
What is the current status of trial NCT04669158?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 53 participants. The study started on 2021-07-30. Estimated completion is 2023-07-05.
What interventions are being tested in trial NCT04669158?
The interventions under investigation include: Placebo (DRUG), Idebenone (DRUG).
Who is sponsoring clinical trial NCT04669158?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04669158's enrollment target sits among peer trials
53 948th of 2000 higher than 1,045 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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