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

NCT06565611 · Active, not recruiting

Last updated 2026-05-28

This clinical trial is testing whether combining two medications, bremelanotide and tirzepatide, helps reduce body weight in adults with obesity.

Status Active, not recruiting Ongoing, but no longer enrolling new participants.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, triple-blind treatment study

Participants 108 people Planned (estimated).

Who can join Ages 18–65 · all sexes

Timeline Started 2024-08 · est. completion 2025-03

Where 4 sites · United States

What this study is testing ClinicalTrials.gov NCT06565611 ↗

Description as written by the study sponsor.

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).

Treatments tested

bremelanotide Drug

bremelanotide (BMT) sterile aqueous solution for subcutaneous injection, provided as autoinjectors containing 0.3 mL volume
tirzepatide Drug

tirzepatide (GLP-1/GIP) will be provided in its commercial form for SC injection.

Main thing measured	Percent change in body weight between treatment arms
Sponsor	Palatin Technologies, Inc
Conditions studied	Obesity
GLP-1 drugs	tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06565611 ↗