Rhythm Pharma Reports Positive Clinical Data for Setmelanotide, Bivamelagon
Rhythm Pharmaceuticals announced positive new data from multiple presentations at ENDO 2026 for its therapies, setmelanotide and bivamelagon. Setmelanotide demonstrated robust, sustained weight loss and improved weight-related outcomes in patients with acquired hypothalamic obesity (HO) and Bardet-Biedl syndrome (BBS). Oral bivamelagon also showed progressive reductions in BMI and hunger in acquired HO patients. These results highlight the potential of MC4R agonism to address hyperphagia and obesity in rare neuroendocrine diseases.
Key Highlights
- Setmelanotide achieved -18.9% mean BMI reduction in acquired HO patients over 2.5 years.
- Bivamelagon showed mean BMI reductions from -6.7% to -16.6% in acquired HO patients at one year.
- Bivamelagon also achieved mean hunger score reductions from -1.9 to -4.8 in acquired HO patients.
- Setmelanotide led to 71.1% pediatric and 71.4% adult acquired HO patients achieving ">=1 weight category improvement.
- Real-world data showed 62% of adults with BBS on setmelanotide achieved ">=10% body weight loss.
- Setmelanotide reduced mean Symptoms of Hyperphagia scores by -0.5 at 6 months in BBS patients.
- Setmelanotide reduced mean Impacts of Hyperphagia scores by -1.3 at 6 months in BBS patients.
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