Trial intelligence / Profile preview

Setmelanotide in Prader-Willi Syndrome

NCT06772597Phase 2

Key facts

Status: Active, not recruiting
Start: Mar 2025
Primary completion: Oct 2026
Countries: 1
Sponsor: Rhythm Pharmaceuticals
Modality: Peptides, Small Molecules

Drugs: setmelanotide
Conditions: Prader-Willi syndrome (PWS)obesityhyperphagia

Overview

Phase 2, open-label, single-arm trial of setmelanotide in Prader-Willi syndrome (PWS), obesity and hyperphagia, sponsored by Rhythm Pharmaceuticals. Primary endpoint: Frequency and severity of adverse events at 52 weeks. Started Mar 2025; status: active, not recruiting.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Setmelanotide (Open-label)
Single group receiving open-label setmelanotide for 52 weeks.

Who it enrols

Patients aged 6-65 with Prader-Willi Syndrome and obesity (BMI ≥30 for adults or ≥95th percentile for children).

Endpoints

Primary

Frequency and severity of adverse events52 weeks

Secondary

Proportion of patients who achieve 5% reduction in BMI52 weeks
Mean percent change in BMI52 weeks
Mean percent change in weight in patients ≥18 years of age52 weeks
Mean change in BMI Z-Score52 weeks
Mean change in BMI % of 95th percentile52 weeks
Proportion of patients who achieved 5% reduction in weight from Baseline in patients ≥18 years of age52 weeks
Proportion of patients who achieved ≥0.2 reduction in BMI Z-score in patients <18 years of age52 weeks
Prader-Willi Syndrome Food Problem Diary total score52 weeks

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