A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity

What Was Tested

In this phase 2 trial, researchers set out to test PT-141 (Bremelanotide) and Tirzepatide.

It had four arms (groups): tirzepatide and bremelanotide Combination Therapy (active comparator), tirzepatide Monotherapy (placebo comparator), bremelanotide Monotherapy (placebo comparator) and Placebo (no intervention).

N=1.

The registry classes the interventions as drug.

More on the Plan

A total of approximately 108 subjects at approximately five (5) centers within the United States (US), will be enrolled into the study for 8 weeks of treatment.

Subjects who provide written informed consent and meet all initial eligibility criteria will enter into Screening.

The subjects' historical and current medical data will be collected, reviewed, and recorded to be used as baseline values.

Enrolled subjects will begin the study and go through 2 treatment periods: * "Treatment Period 1" - 4 weeks of tirzepatide therapy only * "Treatment Period 2" - 4 weeks of combination therapy of bremelanotide, Placebo, or tirzepatide therapy.

Who Took Part

108 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Male or female aged between 18-65 years of age, inclusive at the time of consent. Have a body mass index (BMI) of 30.0 to 45.0 kg/m\^2 (inclusive) at screening. Age ≥ 50 years, no menses for at least one year, per subject self-report. Documented hysterectomy, bilateral tubal ligation, or bilateral oophorectomy. Surgical sterilization of the subject or male partner;.

The full record lists 19 inclusion and 23 exclusion criteria; among the exclusions: females who are pregnant, breastfeeding or plan to become pregnant; have a known allergy or intolerance to melanocortin peptides; subjects 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

It was run as a randomized, parallel-group and triple-blind study.

Because people in this PT-141 (Bremelanotide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The PT-141 (Bremelanotide) group and the comparison group ran side by side rather than switching.

As a double-blind PT-141 (Bremelanotide) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2024-08-05 with completion listed for 2025-02-05.

It ran at 4 sites in United States (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent change in body weight between treatment arms (time frame: Change from the baseline (Visit 2/Day 1) to Visit 10 (Day 57)).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of PT-141 (Bremelanotide) and Tirzepatide in 108 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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