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NCT05284617 · ClinicalTrials.gov registry record · Phase 2
Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF
A Phase 2 study, sponsored by Rivus Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
NCT05284617: Completed Phase 2 study, sponsored by Rivus Pharmaceuticals.
NCT05284617 is a Phase 2 study that has completed, run by Rivus Pharmaceuticals. The registered enrollment target is 67 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05284617, a Phase 2 study, has completed, sponsored by Rivus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
Study Summary
This is a Phase 2A, randomized, parallel-group, placebo-controlled, double-blind, within subject dose escalation trial with 3 dose levels of HU6 and placebo. Subjects will be randomized (1:1) either to HU6 or placebo. Two dose levels will be administered in sequential order (150 mg daily followed by 300 mg daily), each for 20 days, to reach the third and highest dose of 450 mg daily if safety and tolerability are demonstrated at the lower 2 preceding doses. Administration of the 450 mg high dose will continue for a total of 94 days, with a safety follow-up visit within \~14 days of the last dose.
Primary Outcome
Assess the rate and amount of body weight loss over the course of HU6 treatment
Interventions
- DRUG Placebo
- DRUG HU6
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2022-10-30 |
| Est. Completion | 2024-05-30 |
| Phase | Phase 2 |
What the finished NCT05284617 record still lists
NCT05284617 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05284617 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05284617 about?
NCT05284617 is a clinical study titled "Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF". This is a Phase 2A, randomized, parallel-group, placebo-controlled, double-blind, within subject dose escalation trial with 3 dose levels of HU6 and placebo. Subjects will be randomized (1:1) either to HU6 or placebo. Two dose levels will be administered in sequential order (150 mg daily followed by...
What is the current status of trial NCT05284617?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2022-10-30. Estimated completion is 2024-05-30.
What interventions are being tested in trial NCT05284617?
The interventions under investigation include: Placebo (DRUG), HU6 (DRUG).
Who is sponsoring clinical trial NCT05284617?
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 NCT05284617's enrollment target sits among peer trials
67 974th of 2000 higher than 1,026 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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