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

What Was Tested

The trial (phase 2) is built around PT-141 (Bremelanotide).

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.

It had 1 arm (groups): Subcutaneous Bremelanotide (experimental).

BMT sterile aqueous solution for injection provided as a prefilled syringe, administered by subcutaneous (SQ) injection into the abdomen.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

The registry lists 16 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have a BMI ≤ 45 kg/m\^2 at screening. Have a diagnosis of Stage I, II, or III diabetic nephropathy, confirmed by renal biopsy within 5 years of Screening. For female subjects:. Alternatively, a female of non-childbearing potential is defined as:. For male subjects:.

The full record lists 16 inclusion and 15 exclusion criteria; among the exclusions: females who are pregnant or breastfeeding or plan to become pregnant or donate ova during the trial or 30 days after trial participation; has a known allergy or intolerance to aeci, arb, or melanocortin peptides; patients with a positive serum antigen/antibody hepatitis panel (hep b and c) and hiv antibody test human immunodeficiency virus (hiv) antibody.

How the Study Was Run

Design: single-group and open-label.

Everyone knew when PT-141 (Bremelanotide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2022-12-26 with completion listed for 2024-04-26.

It ran at 9 sites in United States (9).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): 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 (time frame: Baseline to after six months of combined therapy (RAAS inhibition therapy plus BMT)).

What This Means in Plain Language

Put simply, this is a phase 2 trial of PT-141 (Bremelanotide) in 16 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the PT-141 (Bremelanotide) compound page, all human trials.