Weight Reduction in Patients with Hypothalamic Obesity Treated with Setmelanotide for 12 Months

Background: Hypothalamic obesity (HO) is an acquired form of severe obesity characterized by rapid and excessive weight gain resulting from insult to the hypothalamus-primarily caused by tumor invasion, resection, or radiotherapy-that can impair melanocortin-4 receptor (MC4R) pathway signaling. Treatment with setmelanotide, an MC4R agonist, resulted in weight and hunger reduction at 16 weeks in a Phase 2 trial of patients with HO. Here, we report changes in weightrelated parameters after 12 months of setmelanotide treatment in patients with HO who entered a long-term extension (LTE) trial. Methods: The Phase 2, multicenter, open-label study (NCT04725240) was a 16-week trial in patients aged >6 to