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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 is a Phase 2 study that has completed, run by Rivus Pharmaceuticals. The registered enrollment target is 67 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05284617
The ClinicalTrials.gov registry entry for NCT05284617 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rivus Pharmaceuticals, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05284617 reports 0 study locations.
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.
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