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ACTIVE NOT RECRUITING
NCT06565611
PHASE2

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

Sponsor: Palatin Technologies, Inc

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

108

Start Date

2024-08-05

Completion Date

2025-03-31

Last Updated

2025-03-06

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (4)

University Clinical Research-DeLand LLC, d/b/a Accel Research

DeLand, Florida, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Coastal Carolina Research Center

North Charleston, South Carolina, United States

Lynn Institute of Chattanooga

Chattanooga, Tennessee, United States