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A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity
NCT06565611 · View on ClinicalTrials.gov ↗
Study 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).
Conditions Studied
Interventions
- DRUG tirzepatide
- DRUG bremelanotide
Study Locations (4)
Florida
- University Clinical Research-DeLand LLC, d/b/a Accel Research — DeLand
Oklahoma
- Lynn Health Science Institute — Oklahoma City
South Carolina
- Coastal Carolina Research Center — North Charleston
Tennessee
- Lynn Institute of Chattanooga — Chattanooga
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 108 participants |
| Start Date | 2024-08-05 |
| Est. Completion | 2025-03-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06565611
The ClinicalTrials.gov registry entry for NCT06565611 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 108 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Palatin Technologies, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 2 interventions — of which tirzepatide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06565611 reports 4 study locations spanning 4 distinct geographic areas — top geographies include Florida, Oklahoma, South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06565611 about?
NCT06565611 is a clinical study titled "A Phase 2 Study Evaluating the Co-Administration of Bremelanotide With Tirzepatide for the Treatment of Obesity". 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).
What is the current status of trial NCT06565611?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 108 participants. The study started on 2024-08-05. Estimated completion is 2025-03-31.
What conditions does trial NCT06565611 study?
This clinical trial studies the following conditions: Obesity. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06565611?
The interventions under investigation include: tirzepatide (DRUG), bremelanotide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06565611?
This trial is sponsored by Palatin Technologies, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06565611 being conducted?
This trial has 4 study locations across Florida, Oklahoma, South Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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