NCT06565611

A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity

A Phase II, Randomized, Double-Blind, Placebo-Controlled, Clinical Study Investigating the Safety, Tolerability, and Effectiveness of the Co-Administration of Bremelanotide With Tirzepatide (GLP-1/GIP) for the Treatment of Obesity

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Palatin Technologies, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	bremelanotide	bremelanotide (BMT) sterile aqueous solution for subcutaneous injection, provided as autoinjectors containing 0.3 mL volume
DRUG	tirzepatide	tirzepatide (GLP-1/GIP) will be provided in its commercial form for SC injection.

Timeline

• Start date: 2024-08-05
• Primary completion: 2025-02-05
• Completion: 2025-03-31
• First posted: 2024-08-22
• Last updated: 2025-03-06

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study