drugset / Trial / NCT05709444

A Phase IIb, Multicenter, Open-Label, Prospective Study of Bremelanotide in Diabetic Kidney Disease

NCT05709444

Phase 2 Completed 16 enrolled Palatin Technologies, Inc
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-12-26
Primary completion
2024-04-26
Completion
2024-04-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Bremelanotide Peptide Subcutaneous

Indications