Trial · Interventional
Active, not recruitingPhase 2Registry dataA Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity
Short name BMT-801
Overview
- Status
- Active, not recruiting
- Phase
- Phase 2
- Enrollment
- 108 participants (estimated)
- Sponsor
- Palatin Technologies, Inc · Industry
- Design
- Randomized · Triple masking
- Countries
1 country
United States
- Start
- 5 Aug 2024
- Primary completion
- 5 Feb 2025
- Completion
- 31 Mar 2025 (estimated)
- First posted
- 22 Aug 2024
- Last update posted
- 6 Mar 2025
- Conditions
- Obesity
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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).
Interventions
- bremelanotideDrug
- tirzepatideDrug
Arms4
Active comparator
tirzepatide and bremelanotide Combination Therapy
Placebo comparator
tirzepatide Monotherapy
N=1
Placebo comparator
bremelanotide Monotherapy
No intervention
Placebo
Primary outcomes1
Outcomes the sponsor listed as primary.
Percent change in body weight between treatment arms
Time frame · Change from the baseline (Visit 2/Day 1) to Visit 10 (Day 57)
Registry description
Percent change in patient weight from baseline (Visit 2/Day 1) to Visit 10 (Day 57) for the BMT/tirzepatide combination group compared to placebo
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 65 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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