Clinical TrialMay 12, 2026, 08:02 AM
Rhythm Pharma's Setmelanotide Shows Significant BMI & Metabolic Benefits
AI Summary
Rhythm Pharmaceuticals announced new data presentations at The European Congress of Endocrinology for setmelanotide. Real-world data from France showed clinically meaningful BMI reductions of up to 16.9% and improvements in obesity classes in adults with acquired hypothalamic obesity (HO). Phase 3 analyses further demonstrated significant improvements across multiple cardiometabolic risk indices with setmelanotide in acquired HO. Additionally, new research highlighted the under-recognition and burden of hyperphagia in Bardet-Biedl syndrome and acquired HO.
Key Highlights
- Real-world data showed mean BMI reduction of -13.0% at 6 months (n=39) and -16.9% at 12 months (n=25) in acquired HO patients.
- 18.0% to 34.6% of acquired HO patients no longer lived with obesity after 6-12 months of setmelanotide treatment.
- Phase 3 analysis showed setmelanotide reduced metabolic syndrome z-score by -0.9 vs -0.2 for placebo (p<0.0001).
- Setmelanotide reduced Lipid Accumulation Product (LAP) by -36.4 vs -2.6 for placebo (p<0.0001) in Phase 3 trial.
- Setmelanotide reduced Triglyceride-Glucose Waist Circumference Index (TyG-WC) by -138.3 vs +21.2 for placebo (p<0.0001).
- Setmelanotide reduced Fatty Liver Index (FLI) by -24.2 vs +4.4 for placebo (p<0.0001).
- A study on Bardet-Biedl syndrome found 69.2% of adults had severe hyperphagia by interview vs 7.7% by questionnaire.