← Human Trials & Peer-Reviewed Studies
Setmelanotide for the Treatment of Early-Onset Pro-Opiomelanocortin (POMC) Deficiency Obesity
Plain-language guide to NCT02896192: phase 3 interventional trial of Setmelanotide, 15 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02896192
- Phase
- phase 3
- Status
- completed
- Start
- 2017-02-14
- Completion (planned or actual)
- 2020-05-25
- Participants
- 15 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Pro-opiomelanocortin (POMC) Deficiency Obesity
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around 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.
The full record lists 6 inclusion and 14 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; participant is, in the opinion of the study investigator, not suitable to participate in the study.
How the Study Was Run
Design: single-group and open-label.
Being open-label, the Setmelanotide study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2017-02-14 with completion listed for 2020-05-25.
It ran at 7 sites in United States (1), Belgium (1), Canada (1), France (1), Germany (1) and Spain (1).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 10 secondary outcomes, for example Mean Percent Change From Baseline in Body Weight at Week 52, Mean Percent Change From Baseline in Hunger Score (Worst "Most" Hunger in 24 Hours) at Week 52, Absolute Change From Baseline in Waist Circumference at Week 52, 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 (BMI) at Week 52 and Area Under the Curve (AUC) Change From Baseline in Oral Glucose, Assessed by the Oral Glucose Tolerance Test (OGTT).
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.