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Long Term Extension Trial of Setmelanotide
Plain-language guide to NCT03651765: phase 2, phase 3 interventional trial of Setmelanotide, 205 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03651765
- Phase
- phase 2, phase 3
- Status
- completed
- Start
- 2018-07-15
- Completion (planned or actual)
- 2025-01-09
- Participants
- 205 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Obesity Associated With Defects in Leptin-melanocortin Pathway
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2, phase 3) is built around Setmelanotide.
It had 1 arm (groups): Setmelanotide (experimental).
The registry classes the interventions as drug.
More on the Plan
The primary objectives of this extension trial were to explore the long-term safety and tolerability of setmelanotide for up to 7 years or until drug was otherwise available through authorized use.
Who Took Part
Enrollment: 205 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.
Examples of who could join: Participant and/or parent or guardian was able to communicate with the investigator, understand and sign the written informed consent/assent, and comply with the trial requirements.
The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: pregnant and/or breastfeeding women; documented diagnosis of schizophrenia, bipolar disorder, personality disorder, major depressive disorder, or other psychiatric disorder(s); suicidal ideation, attempt or behavior.
How the Study Was Run
The set-up was 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 2018-07-15 with completion listed for 2025-01-09.
It ran at 27 sites in United States (15), Germany (3), United Kingdom (3), France (2), Canada (1) and Greece (1).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (TEAEs).
What This Means in Plain Language
Put simply, this is a phase 2, phase 3 trial of Setmelanotide in 205 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
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.