Palatin Technologies, Inc. announced the initiation of a Phase 2 clinical study of bremelanotide for the treatment of obesity. The clinical study will evaluate the safety and efficacy of bremelanotide, a melanocortin 4 receptor (MC4R) agonist, co-administered with tirzepatide (GLP-1/GIP) in obese patients. The primary endpoint of the trial is to demonstrate the safety and increased efficacy of the co-administration of bremelanotide with tirzepatide on reducing body weight.

Topline data results are expected by the end of calendar year 2024. The clinical study, titled BMT-801: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Clinical Study Investigating the Safety, Tolerability, and Effectiveness of the Co-Administration of Bremelanotide with Tirzepatide (GLP-1/GIP) for the Treatment of Obesity has Food and Drug Administration clearance. The study is designed to enroll up to 60 patients who are actively on tirzepatide at five trial sites in the United States.

Patients will undergo multiple assessments of safety and efficacy to help profile the effectiveness of bremelanotide in treating general obesity as a stand-alone treatment or in conjunction with GLP-1/GIP therapy.