A Study of Setmelanotide in Patients With Prader-Willi Syndrome

Plain-language guide to NCT06772597: phase 2 interventional trial of Setmelanotide, hyperparathyroidism, 18 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT06772597
Phase: phase 2
Status: active, not recruiting
Start: 2025-03-04
Completion (planned or actual): 2026-10-31
Participants: 18 (actual)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Prader-Willi Syndrome; Obesity; Hyperphagia
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

The trial (phase 2) is built around Setmelanotide for hyperparathyroidism.

Up to 20 patients are planned to be enrolled.

It had 1 arm (groups): Setmelanotide (Open-label) (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 18 actual participants took part.

It was open to people of any sex aged from 6 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Confirmed diagnosis of Prader-Willi Syndrome (PWS). Age 6 to 65. BMI ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th Percentile for age and sex. Patient and/or guardian is able to communicate well with the Investigator, understand and comply with the requirements of the study, and understand English and sign the written informed consent.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: use of weight modulating medications; abnormal egfr, alt, ast, and bilirubin values; hypersensitivity to setmelanotide.

How the Study Was Run

Design: 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 2025-03-04 with completion listed for 2026-10-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Frequency and severity of adverse events (AEs) (time frame: Baseline to Week 52).

It also tracked 6 secondary outcomes, for example Mean percent change in BMI, Mean percent change in BMI and weight in patients ≥18 years of age, Mean change in BMI Z-Score and BMI % of 95th percentile and Mean change in the weekly average of the Prader-Willi Syndrome Food Problem Diary (PWS-FPD) total score.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Setmelanotide in 18 people with hyperparathyroidism.

Its size is small, so on its own it can only give an early look.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Setmelanotide compound page, Hyperparathyroidism research.

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).

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.