Clinical trialNCT05709444CompletedPhase 2Interventional

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

SponsorPalatin Technologies, IncEnrollment16Kidney Disease

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

James Tumlin, MD
Georgia Nephrology Research Institute
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗
Robert Jordan
Palatin
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

9 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

California Institute of Renal Research
Chula Vista, California, United States
California Institute of Renal Research Dba - Balboa Research
La Mesa, California, United States
Georgia Nephrology, Llc Dba -Ga Nephrology Research Institute
Decatur, Georgia, United States
Georgia Nephrology, Llc [dba] Ga Nephrology Research Institute
Lawrenceville, Georgia, United States
Brookview Hills Research Associates, Llc
Winston-Salem, North Carolina, United States
Northeast Research Center, Llc
Bethlehem, Pennsylvania, United States
Nephrotex Research Group
Dallas, Texas, United States
Prolator Clinical Research Center
Houston, Texas, United States
Clinical Advancement Center, Pllc
San Antonio, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

BremelanotideRAAS inhibition therapy

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 26 Dec 2022
Primary completion: 26 Apr 2024
Completion: 26 Apr 2024
Last update posted: 17 Oct 2024
Registered enrollment: 16
Registry id: NCT05709444

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.