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NCT05709444 · ClinicalTrials.gov registry record · Phase 2
A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease
A Phase 2 study, sponsored by Palatin Technologies.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT05709444: Completed Phase 2 study, sponsored by Palatin Technologies.
NCT05709444 is a Phase 2 study that has completed, run by Palatin Technologies. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05709444, a Phase 2 study, has completed, sponsored by Palatin Technologies.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
This is a prospective, open-label trial to assess the efficacy of melanocortin receptor agonist bremelanotide (BMT) when administered with RAAS inhibition therapy after six months in subjects with Type II diabetic nephropathy. After six months of therapy, all subjects will remain in trial for further assessment and undergo a diagnostic renal biopsy to assess the effect of melanocortin therapy on diabetic histopathology at 12 months.
Primary Outcome
Proportion of subjects with Type II diabetic nephropathy who achieve a 50% reduction in their urine protein Cr (UP/Cr) ratio after six months of combined therapy (RAAS inhibition therapy plus BMT). Inhibition therapy to reduce urinary protein and maintain podocyte density and functions in subjects with Type II diabetic nephropathy after six months.
Interventions
- DRUG Bremelanotide
- DRUG RAAS inhibition therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-12-26 |
| Est. Completion | 2024-04-26 |
| Phase | Phase 2 |
What the finished NCT05709444 record still lists
NCT05709444 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Bremelanotide is the first listed.
NCT05709444 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05709444 about?
NCT05709444 is a clinical study titled "A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease". This is a prospective, open-label trial to assess the efficacy of melanocortin receptor agonist bremelanotide (BMT) when administered with RAAS inhibition therapy after six months in subjects with Type II diabetic nephropathy. After six months of therapy, all subjects will remain in trial for furthe...
What is the current status of trial NCT05709444?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2022-12-26. Estimated completion is 2024-04-26.
What interventions are being tested in trial NCT05709444?
The interventions under investigation include: Bremelanotide (DRUG), RAAS inhibition therapy (DRUG).
Who is sponsoring clinical trial NCT05709444?
This trial is sponsored by Palatin Technologies, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05709444's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 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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