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Completed PHASE2 INTERVENTIONAL NCT05709444

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief 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.

Detailed Description

A total of 45 subjects with biopsy-proven Type II diabetic nephropathy and \>1000 mg/gm UP/Cr ratio will be enrolled to receive BMT therapy in addition to their maximum tolerated RAAS inhibition therapy for six months. The subjects' historical medical and laboratory data collected at four timepoints, approximately 24, 18, 12, and 6 months prior to Day 0, will be reviewed and recorded to be used as baseline values.

Interventions

Name: Bremelanotide

Type: DRUG

Description: Bremelanotide is a cyclic, heptapeptide analog of the endogenous peptide alpha melanocortin stimulating hormone (αMSH).

Name: RAAS inhibition therapy

Type: DRUG

Description: RAS-acting agents are medicines acting on a hormone system that helps to control blood pressure and the amount of fluid in the body.

Primary Outcomes

Measure: To demonstrate the efficacy of 0.5 mg subcutaneous BMT (given twice a day), used in combination with a subject's maximum tolerated dose of RAAS inhibition therapy, reduces urinary protein by 50% from baseline UP/Cr levels.

TimeFrame: Baseline to after six months of combined therapy (RAAS inhibition therapy plus BMT).

Description: 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.

Measure: To determine the incidence of overall adverse events, related adverse events, a composite of adverse events of special interest, serious adverse events, and the incidence of BMT discontinuation.

TimeFrame: Baseline to after six months of combined therapy (RAAS inhibition therapy plus BMT).

Description: 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) to determine the incidence of adverse events, related adverse events, adverse events of special interest, serious adverse events and BMT discontinuation.

Trial Information

NCT ID

NCT05709444

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Palatin Technologies, Inc

Last Updated

December 15, 2025