Open-Label Extension Study of Setmelanotide
Public ClinicalTrials.gov record NCT06596135. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Open-Label Extension Study of Setmelanotide in Patients With a Rare Genetic, Syndromic or Acquired Disease of the MC4R Pathway
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is an open-label extension study designed to evaluate the long-term safety and tolerability of continued setmelanotide treatment in male and female patients ≥2 years of age who have completed or transitioned from a previous study with setmelanotide for rare genetic, syndromic, or acquired diseases of obesity upstream of the MC4R pathway.
Study identification
- NCT ID
- NCT06596135
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 28 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 2 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 20, 2024
- Primary completion
- Jun 23, 2026
- Completion
- Jun 23, 2026
- Last update posted
- Jul 14, 2026
2024 – 2026
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| HonorHealth Research Institute | Scottsdale | Arizona | 85258 | — |
| UC San Diego- Rady Children's Hospital | San Diego | California | 92123 | — |
| University of Florida at Gainesville | Gainesville | Florida | 32611 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | — |
| Children's Minnesota | Saint Paul | Minnesota | 55102 | — |
| University of Buffalo | Getzville | New York | 14068 | — |
| M3 Wake Research, Inc | Raleigh | North Carolina | 27612 | — |
| Geisinger Health System | Danville | Pennsylvania | 17821 | — |
| WR-ClinSearch | Chattanooga | Tennessee | 37421 | — |
| Vanderbilt University School of Medicine | Nashville | Tennessee | 37232 | — |
| Seattle Children's Research Institute | Seattle | Washington | 98105 | — |
| Marshfield Clinical Research Institute | Marshfield | Wisconsin | 54449 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06596135, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 14, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06596135 live on ClinicalTrials.gov.