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Open-Label Extension Study of Setmelanotide
Plain-language guide to NCT06596135: phase 3 interventional trial of Setmelanotide, 28 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT06596135
- Phase
- phase 3
- Status
- completed
- Start
- 2024-10-21
- Completion (planned or actual)
- 2026-06-24
- Participants
- 28 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Obesity Associated With Defects in Leptin-melanocortin Pathway
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Setmelanotide.
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.
It had 1 arm (groups): Setelanotide (Open-label) (experimental).
Once daily (QD) subcutaneous injection of setmelanotide.
The registry classes the interventions as drug.
Who Took Part
28 actual participants took part.
It was open to people of any sex aged from 2 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: any gene variant, syndromic, or acquired disease for which setmelanotide is currently approved in the united states (i.e., patients eligible for commercial setmelanotide (imcivree®); any new or worsening depression resulting in suicidal thoughts and/or behaviors; discontinuation from a previous setmelanotide study.
How the Study Was Run
Design: single-group and open-label.
Nothing was hidden in this open-label Setmelanotide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2024-10-21 with completion listed for 2026-06-24.
It ran at 13 sites in United States (13).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Safety and tolerability of setmelanotide assessed by frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 3 years).
What This Means in Plain Language
Put simply, this is a phase 3 trial of Setmelanotide in 28 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Setmelanotide compound page, all human trials.
Our Notes on the Compound
Setmelanotide: An FDA-approved melanocortin-4 receptor agonist for rare genetic obesity (POMC, PCSK1, LEPR deficiency and Bardet-Biedl syndrome).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.