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Setmelanotide to Treat Obesity in a Patient With Pseudohypoparathyroidism Type 1a (PHP1a)
Plain-language guide to NCT07496463: phase 2 interventional trial of Setmelanotide, 1 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07496463
- Phase
- phase 2
- Status
- enrolling by invitation
- Start
- 2026-07-21
- Completion (planned or actual)
- 2027-04-30
- Participants
- 1 (estimated)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Pseudohypoparathyroidism Type 1a; Obesity
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Setmelanotide.
It had 1 arm (groups): Patient with pseudohypoparathyroidism type 1a (other).
A preselected patient with obesity related to pseudohypoparathyroidism type 1a.
The registry classes the interventions as drug.
More on the Plan
Pseudohypoparathyroidism type 1A (PHP1a) is a rare genetic disorder caused by impaired G-protein signaling due to heterozygous mutations in the gene GNAS.
Multiple abnormalities may result including hypocalcemia, hypothyroidism, hypogonadism, and developmental delay.
Obesity also commonly occurs due to impaired signaling through the melanocortin-4 receptor (MC4R).
The melanocortin-4 receptor agonist setmelanotide has been proposed as a potential yet untested treatment strategy for patients with pathogenic GNAS variants.
Who Took Part
The registry lists 1 planned participants were the target.
It was open to people of any sex.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Known patient with PHP1a (confirmed GNAS mutation). Optimized therapy for diabetes and dyslipidemia.
The full record lists 2 inclusion and 0 exclusion criteria.
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 2026-07-21 with completion listed for 2027-04-30.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 4 secondary outcomes, for example Percent Weight Loss, Trunk Fat Mass, Hemoglobin A1c and Serum Triglycerides.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Setmelanotide in 1 people.
Its size is small, so on its own it can only give an early look.
Its status is enrolling by invitation; 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.