A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity
NCT Number: NCT06565611
Acronym: BMT-801
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Obesity
Interventions: DRUG: Bremelanotide|DRUG: Tirzepatide
Sponsor: Palatin Technologies, Inc
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-05
Completion Date: 2025-03-31
Locations: University Clinical Research-DeLand LLC, d/b/a Accel Research, DeLand, Florida, 32720, United States|Lynn Health Science Institute, Oklahoma City, Oklahoma, 73112, United States|Coastal Carolina Research Center, North Charleston, South Carolina, 29405-5093, United States|Lynn Institute of Chattanooga, Chattanooga, Tennessee, 37404, United States

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).

Primary Outcome Measures: Change in body weight between treatment arms, Change in body weight between treatment arms at Week 8, Change from Baseline to Week 8
Secondary Outcome Measures: Change in Visual Analog Scale (VAS) appetite suppression subscales, Change in each of the appetite suppression subscales (hunger, fullness, satiety, prospective food consumption) between treatment arms at Week 8 Min Value (Satiety, Fullness): 0; Max Value (Satiety, Fullness): 100; Min Value (Hunger, PFC): 100 Max Value (Hunger, PFC): 0. Minimum values indicate a worst score (very hungry). Maximum values indicate a better score (not hungry)., Change from Baseline to Week 8|Change in Neck and Waist measurements with a Measuring Tape (Inches), For men, the circumference of the neck is measured by placing a measuring tape directly on the skin just below the larynx and extending horizontally all the way around the neck. For the abdominal measurement, the tape measure is placed around the belly and over the belly button and extended horizontally all the way around. In addition to neck and waist, testing body fat for women also requires measuring the hips. The neck measurement for women is taken the same way as for men. The method for measuring a woman's waist differs from the method for men. It is measured at the natural waist, which is generally located halfway between the belly button and the sternum. The tape measure needs to be horizontal all the way around and the measurement is taken on the exhale. The hip measurement is taken around the hips, passing over the fullest part of the buttocks, and rounded down to the nearest half inch., Change from Baseline to Week 8|Evaluating differences in lean muscle mass via Bioimpedance Scale, Change in lean muscle mass through a lean mass assessment conducted with a Bioimpedance Scale between treatment arms at Week 8., Change from Baseline to Week 8|Changes in Glucose levels assessed via blood draw, Changes in Glucose levels between treatment arms at week 8 assessed via blood draw, Change from Baseline to Week 8|Changes in Calcium levels assessed via blood draw, Changes in Calcium levels between treatment arms at week 8 assessed via blood draw, Change from Baseline to Week 8|Changes in Total Protein levels assessed via blood draw, Changes in Total Protein levels between treatment arms at week 8 assessed via blood draw, Change from Baseline to Week 8|Changes in Bilirubin levels assessed via blood draw, Changes in Bilirubin levels between treatment arms at week 8 assessed via blood draw, Change from Baseline to Week 8|Changes in BUN (blood urea nitrogen) levels assessed via blood draw, Changes in BUN (blood urea nitrogen) levels between treatment arms at week 8 assessed via blood draw, Change from Baseline to Week 8|Changes in Creatinine levels assessed via blood draw, Changes in Creatinine levels between treatment arms at week 8 assessed via blood draw, Change from Baseline to Week 8|Changes in Albumin levels assessed via blood draw, Changes in Albumin levels between treatment arms at week 8 assessed via blood draw, Change from Baseline to Week 8|Changes in Sodium levels assessed via blood draw, Changes in Sodium levels between treatment arms at week 8 assessed via blood draw, Change from Baseline to Week 8|Changes in Potassium levels assessed via blood draw, Changes in Potassium levels between treatment arms at week 8 assessed via blood draw, Change from Baseline to Week 8|Changes in Bicarbonate levels assessed via blood draw, Changes in Bicarbonate levels between treatment arms at week 8 assessed via blood draw, Change from Baseline to Week 8|Changes in Chloride levels assessed via blood draw, Changes in Chloride levels between treatment arms at week 8 assessed via blood draw, Change from Baseline to Week 8|Changes in Alkaline phosphatase (ALP) levels assessed via blood draw, Changes in Alkaline phosphatase (ALP) levels between treatment arms at week 8 assessed via blood draw., Change from Baseline to Week 8|Changes in Alkaline transaminase (ALT) levels assessed via blood draw, Changes in Alkaline transaminase (ALT) levels between treatment arms at week 8 assessed via blood draw, Change from Baseline to Week 8|Changes in Aspartate aminotransferase (AST) levels assessed via blood draw, Changes in Aspartate aminotransferase (AST) levels between treatment arms at week 8 assessed via blood draw, Change from Baseline to Week 8|Changes in Total Cholesterol Levels assessed through blood draw., Changes in Total Cholesterol Levels assessed through blood draw between treatment arms at Week 8., Change from Baseline to Week 8|Changes in LDL ("bad") Cholesterol Levels assessed through blood draw., Changes in LDL ("bad") Cholesterol Levels assessed through blood draw between treatment arms at Week 8., Change from Baseline to Week 8|Changes in HDL ("good") Cholesterol Levels assessed through blood draw., Changes in HDL ("good") Cholesterol Levels assessed through blood draw between treatment arms at Week 8., Change from Baseline to Week 8|Changes in Triglyceride Levels assessed through blood draw., Changes in Triglyceride Levels assessed through blood draw between treatment arms at Week 8., Change from Baseline to Week 8|Change in Overall Appetite Suppression Score (OASS) as measured by Visual Analog Scale (VAS), 1. Change in overall appetite suppression as measured by visual analog scale (VAS) between treatment arms at Week 8 Min Value (OASS): 0; Max Value (OASS): 100. Lower values indicate a worse score (very hungry). Higher values indicate a better score (not hungry)., Change from Baseline to Week 8|Change in International Index of Erectile Function (IIEF)domain score, Change in the IIEF domain score between treatment arms at Week 8. Lower value indicates worse erectile function. Higher value indicates better erectile function.

Erectile Function: Min- 1 Max- 30

Orgasmic Function: Min- 0 Max- 10

Sexual Desire: Min- 2 Max- 10

Intercourse Satisfaction: Min- 0 Max- 15

Overall Satisfaction: Min- 2 Max- 10, Change from Baseline to Week 8|Change in the Elements of Desire Questionnaire (EDQ) score, Change in the Elements of Desire Questionnaire (EDQ) score between treatment arms at Week 8. Min Value: 1; Max Value 5. Lower value indicates worse sexual desire. Higher value indicates better sexual desire., Change from Baseline to Week 8
Other Outcome Measures: The number of participants with Treatment-emergent adverse events (TEAEs)., Safety will be determined through the analyses of number of participants with Treatment-emergent adverse events (TEAEs)., Change from Baseline to Week 8|The number of participants with clinically significant changes in vital signs, Safety will be determined through the analyses of number of participants with clinically significant changes in vital signs, Change from Baseline to Week 8|The number of participants with Clinically significant changes in clinical laboratory test, Safety will be determined through the analyses of number of participants with Clinically significant changes in clinical laboratory test results related to metabolic panel and liver function tests., Change from Baseline to Week 8