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PT-141

Bremelanotide, Vyleesi

Quick Stats
Studies 74
Trials 10
Active Not Recruiting PHASE2 INTERVENTIONAL NCT06565611

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This is a prospective, randomized, double-blind, placebo-controlled study designed to assess the safety and efficacy of bremelanotide (BMT) used in combination with tirzepatide therapy in the treatment of obesity in subjects with a BMI ranging from 30.0 to 45.0 kg/m2 (inclusive).

Detailed Description

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.

Interventions

Name: bremelanotide
Type: DRUG
Description: bremelanotide (BMT) sterile aqueous solution for subcutaneous injection, provided as autoinjectors containing 0.3 mL volume
Name: tirzepatide
Type: DRUG
Description: tirzepatide (GLP-1/GIP) will be provided in its commercial form for SC injection.

Primary Outcomes

Measure: Percent change in body weight between treatment arms
TimeFrame: Change from the baseline (Visit 2/Day 1) to Visit 10 (Day 57)
Description: Percent change in patient weight from baseline (Visit 2/Day 1) to Visit 10 (Day 57) for the BMT/tirzepatide combination group compared to placebo

Trial Information

NCT ID

NCT06565611

Status

Active Not Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE2

Sponsor

Palatin Technologies, Inc

Last Updated

December 15, 2025