The trial aims to enrol up to 60 subjects across four US sites. Credit: SofikoS/Shutterstock.

Palatin Technologies has dosed the first subjects in a Phase II clinical trial evaluating the co-administration of bremelanotide with tirzepatide to treat obesity.

Bremelanotide is a melanocortin 4 receptor (MC4R) while tirzepatide is a GLP-1/GIP receptor agonist.

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Dubbed BMT-801, the randomised, double-blind, placebo-controlled trial is designed to assess the safety, tolerability, and efficacy of this combination therapy.

The trial aims to enrol up to 60 subjects across four US sites.

Demonstrating the safety and enhanced efficacy in reducing body weight through the co-administration of bremelanotide and tirzepatide is the trial’s primary endpoint.

The study will initially treat subjects with tirzepatide alone for four weeks, confirm their eligibility, and then randomise them to one of four treatment regimens, the company noted.

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Throughout the trial, various assessments will be conducted to evaluate the safety and efficacy of bremelanotide, both as monotherapy and in combination with GLP-1/GIP therapy.

Full subject enrolment in the BMT-801 study is anticipated by the third quarter of this year, with topline data read out in the first half of next year.

Palatin Technologies president and CEO Carl Spana said: “We are excited with the start of patient dosing and by the level of patient and physician interest in our Phase II clinical study of an MCR4 agonist plus a GLP-1 to treat obese patients.

“The safe, effective, and consistent treatment and maintenance of weight loss will require multiple therapeutic options with differing mechanisms of action. The MCR4 pathway plays a key role in the regulation of energy storage and food intake, and we see MCR4 agonists playing an important role in future combination therapies.”

In June, the company announced the commencement of a Phase II clinical trial of bremelanotide plus PDE5i for erectile dysfunction treatment.