Palatin Technologies has commenced a Phase II clinical trial of breatelanotide, a melanocortin 4 receptor (MC4R) agonist, to treat obesity.

The trial, which has received clearance from the Food and Drug Administration (FDA), aims to investigate the effectiveness, safety and tolerability of bremelanotide when co-administered with tirzepatide, a GLP-1/GIP therapy, in obese patients.

It is structured to include up to 60 participants who are currently receiving tirzepatide treatment across five trial sites in the US.

Participants will be subject to a series of safety and efficacy assessments. These evaluations will contribute to understanding bremelanotide’s potential as a standalone treatment for obesity or as an adjunct to GLP-1/GIP therapy.

Establishing the safety profile and enhanced efficacy of bremelanotide in conjunction with tirzepatide in reducing body weight is the trial’s primary endpoint.

The company anticipates reporting topline data from the trial by the end of this year.

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Palatin Technologies CEO and president Carl Spana said: “Although GLP-1 agonists are currently the standard of care treatment for obesity, data shows that 67% of patients discontinue use due to side effects and a plateau effect in the first year.

“We believe co-administering an MC4R agonist with a GLP-1 agonist will achieve significant weight loss at lower doses, with improved tolerability and quality of life for these patients. These beliefs are supported by our published preclinical data and multiple clinical studies demonstrating statistically significant effects on reducing food intake and weight loss in obese patients.”

The latest development comes after the company released Phase III MELODY-1 trial results for its dry eye therapy, PL9643, in February.

The drug failed to meet co-primary and secondary endpoints.

Palatin noted that the trial’s demographics were ‘skewed’, with 60% of the 575-participant population aged over 60 and 68% female.