A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity
Brief Summary
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).
Detailed Description
A total of approximately 108 subjects at approximately five (5) centers within the United States (US), will be enrolled into the study for 8 weeks of treatment. Subjects who provide written informed consent and meet all initial eligibility criteria will enter into Screening. The subjects' historical and current medical data will be collected, reviewed, and recorded to be used as baseline values. Enrolled subjects will begin the study and go through 2 treatment periods: * "Treatment Period 1" - 4 weeks of tirzepatide therapy only * "Treatment Period 2" - 4 weeks of combination therapy of bremelanotide, Placebo, or tirzepatide therapy.
Interventions
Primary Outcomes
Trial Information
NCT06565611
Active Not Recruiting
INTERVENTIONAL
PHASE2
Palatin Technologies, Inc
December 15, 2025