Bremelanotide + Tirzepatide for Obesity
(BMT-801 Trial)
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot participate if you are taking certain medications like cyclosporine A, long-term corticosteroids, or anti-obesity medications within 90 days prior to screening. Also, if you are taking oral drugs that depend on specific concentrations for efficacy, you may not be eligible due to potential interactions with bremelanotide.
What data supports the idea that Bremelanotide + Tirzepatide for Obesity is an effective drug?
The available research shows that Tirzepatide, one of the components of the drug, is effective for weight loss in people with obesity. Studies have demonstrated that Tirzepatide helps with significant weight loss and is safe to use. It works by reducing appetite and improving feelings of fullness, which helps people eat less and lose weight. While the research focuses on Tirzepatide alone, it suggests that the drug could be effective for treating obesity.12345
What safety data exists for the combination of Bremelanotide and Tirzepatide for obesity treatment?
The provided research does not contain specific safety data for the combination of Bremelanotide and Tirzepatide for obesity treatment. The studies focus on bombesin receptor antagonists and agonists, which are unrelated to Bremelanotide and Tirzepatide. Therefore, no relevant safety data for this treatment combination is available in the provided research.678910
Is the drug Tirzepatide a promising treatment for obesity?
What is the purpose of this trial?
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).
Research Team
Robert Jordan
Principal Investigator
Palatin
Eligibility Criteria
This trial is for adults with obesity, defined by a BMI of 30.0 to 45.0 kg/m2. Participants must be suitable for treatment with both Bremelanotide and Tirzepatide based on the study's specific requirements.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive tirzepatide therapy only
Treatment Period 2
Participants receive combination therapy of bremelanotide, placebo, or tirzepatide
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Bremelanotide
- Tirzepatide
Bremelanotide is already approved in United States for the following indications:
- Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women
Find a Clinic Near You
Who Is Running the Clinical Trial?
Palatin Technologies, Inc
Lead Sponsor