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NCT04709913 · ClinicalTrials.gov registry record · Phase 1
Multiple Ascending Dose Study of HU6 in High BMI Volunteers
A Phase 1 study, sponsored by Rivus Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT04709913: Completed Phase 1 study, sponsored by Rivus Pharmaceuticals.
NCT04709913 is a Phase 1 study that has completed, run by Rivus Pharmaceuticals. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04709913, a Phase 1 study, has completed, sponsored by Rivus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a 14-day multiple ascending dose trial in high BMI volunteers in up to 4 cohorts of 10 high BMI volunteers each consisting of 8 receiving HU6 and 2 receiving placebo. Upon review of the safety and PK data, it may be decided to expand the current cohort size and/or dose escalate to the next cohort. In addition, the sponsor may elect not to enroll all 4 cohorts based on safety and/or PK and/or PD data, or enlist an additional cohort at a higher dose if deemed safe.
Primary Outcome
Following completion of each cohort, bioanalytical and the PK parameter Cmax will be analyzed.
Interventions
- DRUG HU6
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-01-04 |
| Est. Completion | 2021-07-30 |
| Phase | Phase 1 |
What the finished NCT04709913 record still lists
NCT04709913 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which HU6 is the first listed.
NCT04709913 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04709913 about?
NCT04709913 is a clinical study titled "Multiple Ascending Dose Study of HU6 in High BMI Volunteers". This is a 14-day multiple ascending dose trial in high BMI volunteers in up to 4 cohorts of 10 high BMI volunteers each consisting of 8 receiving HU6 and 2 receiving placebo. Upon review of the safety and PK data, it may be decided to expand the current cohort size and/or dose escalate to the next c...
What is the current status of trial NCT04709913?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2021-01-04. Estimated completion is 2021-07-30.
What interventions are being tested in trial NCT04709913?
The interventions under investigation include: HU6 (DRUG).
Who is sponsoring clinical trial NCT04709913?
This trial is sponsored by Rivus Pharmaceuticals, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04709913's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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