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Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity
Plain-language guide to NCT03287960: phase 3 interventional trial of Setmelanotide, 15 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03287960
- Phase
- phase 3
- Status
- completed
- Start
- 2018-01-30
- Completion (planned or actual)
- 2020-09-25
- Participants
- 15 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Leptin Receptor Deficiency Obesity
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Setmelanotide.
It had 1 arm (groups): Setmelanotide (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 15 actual participants took part.
It was open to people of any sex aged from 6 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age 6 years and above. 6+: Germany, Netherlands, UK. 12+: France.
The full record lists 6 inclusion and 15 exclusion criteria; among the exclusions: A Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15; history or close family history (parents or siblings) of skin cancer or melanoma, or participant history of ocular-cutaneous albinism; volunteer is, in the opinion of the study investigator, not suitable to participate in the study.
How the Study Was Run
The set-up was single-group and open-label.
Everyone knew when Setmelanotide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2018-01-30 with completion listed for 2020-09-25.
It ran at 6 sites in Canada (1), France (1), Germany (1), Netherlands (1), Reunion (1) and United Kingdom (1).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 9 secondary outcomes, for example Mean Percent Change From Baseline in Body Weight, Mean Percent Change From Baseline in Hunger Score ('Most Hunger'), Absolute Change From Baseline in Waist Circumference, Absolute Change in Body Weight (Reversal of Weight Loss) During Double-Blind Placebo-Controlled Withdrawal Period, Mean Percent Change From Baseline in Body Mass Index and Change From Baseline in Glucose Parameters.
What This Means in Plain Language
Put simply, this is a phase 3 trial of Setmelanotide in 15 people.
Its size is small, so on its own it can only give an early look.
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.