The combination therapy achieved its primary goal of percentage weight loss after 8 weeks of treatment.
Palatin Pharmaceuticals announced positive results from a Phase II clinical trial of BMT-801, which evaluated the efficacy of combination therapy with the melanocortin-4 receptor (MC4R) agonist bremelanotide and the glucagon-like peptide-1/gastric inhibitory peptide (GLP-1/GIP) inhibitor tirzepatide for the treatment of obesity. The study met its primary objective: the combination therapy resulted in an average weight loss of 4.4 % in participants.
In a press release, Dr. Carl Spana, President and CEO of Palatin, stated, “While this study was not designed to optimize weight loss, the 8-week trial using low-dose bremelanotide and tirzepatide met its primary objective and demonstrated high statistical significance. The positive results of this study exceeded expectations. The data demonstrated that the combination therapy exerted an additive and synergistic effect, enhancing weight loss, and that the combination therapy did not increase patient tolerability or raise safety concerns. The data also demonstrated that the low dose of the MC4R agonist bremelanotide prevented rapid weight gain after completion of tirzepatide GLP-1/GIP treatment.”
Compared with a 1.6% weight loss in the placebo group, patients in the combination therapy group experienced a 4.4% weight loss, a statistically significant result. Other study findings include:
”This study provides compelling evidence that combining MC4R agonists with GLP-1/GIP compounds can produce a synergistic weight loss effect. These results are consistent with our clinical observations using both mechanisms to treat patients with severe hereditary obesity. Given the urgent need for diverse weight loss regimens, this approach promises to improve on GLP-1/GIP monotherapy, particularly for patients who cannot tolerate high doses,” said Dr. Jesse Richards of the Oklahoma State University College of Orthopaedic Surgery in a press release.
In the BMT-801 study, patients initially received a four-week course of telapatide monotherapy to confirm eligibility. They were then randomized to receive either the MC4R receptor agonist bumelanotide in combination with the GLP-1/GIP receptor agonist telapatide, telapatide alone, bumelanotide alone, or placebo for an additional four weeks. The study enrolled 113 patients, of whom 46 were assigned to the MC4R receptor agonist plus GLP-1/GIP receptor agonist treatment group.
On February 6, Palatin announced the completion of its BMT-801 study. At the time, Spana stated in a press release: “The MC4R pathway plays a critical role in feeding behavior and energy management in the body. Therefore, we believe that MC4R agonists, particularly highly selective, long-acting MC4R peptides and our developing oral small molecule agonists, will play an important role in monotherapy and/or combination therapy for obesity. “
1. Palatin Pharmaceuticals announced that the MC4R agonist bremelanotide in combination with the GLP-1/GIP tirzepatide met the primary endpoint in a phase 2 obesity study. Press release. Palatin Pharmaceuticals. March 31, 2025. Accessed April 2, 2025. https://palatin.com/press_releases/palatin-announces-mc4r-agonist-bremelanotide-co-administered-with-glp-1-gip-tirzepatide-meets-primary-endpoint-in-phase-2-obesity-study/
2. Palatin Pharmaceuticals Completes Phase II Clinical Trial of MC4R Bremelanotide in Combination with GLP-1/GIP Tirzepatide for the Treatment of Obesity. Press Release. Palatin Pharmaceuticals. February 6, 2025. Accessed April 2, 2025. https://palatin.com/press_releases/palatin-completes-phase-2-obesity-study-with-mc4r-bremelanotide-plus-glp-1-gip-tirzepatide/
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Post time: Oct-16-2026