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

Part of paid clinical trials in DeLand, Florida.

Sponsor
Palatin Technologies, Inc
Study ID
NCT06565611
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Aug 5, 2024
Status verified
Mar 2025
Primary completion
Feb 5, 2025
Completion
Mar 31, 2025

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: tirzepatide and bremelanotide Combination Therapy
  • Placebo Comparator: tirzepatide Monotherapy
    N=1
  • Placebo Comparator: bremelanotide Monotherapy
  • No Intervention: Placebo

Primary Outcome Measure

Percent change in body weight between treatment arms [ Time Frame: Change from the baseline (Visit 2/Day 1) to Visit 10 (Day 57) ]

Locations (4)

FacilityCityStateZIPSite coordinators
University Clinical Research-DeLand LLC, d/b/a Accel ResearchDeLandFlorida32720-
Lynn Health Science InstituteOklahoma CityOklahoma73112-
Coastal Carolina Research CenterNorth CharlestonSouth Carolina29405-5093-
Lynn Institute of ChattanoogaChattanoogaTennessee37404-

Find similar trials in DeLand, FL

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University Clinical Research-DeLand LLC, d/b/a Accel Research· DeLand, FLLynn Health Science Institute· Oklahoma City, OKCoastal Carolina Research Center· North Charleston, SCLynn Institute of Chattanooga· Chattanooga, TN

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