Shots:
- The P-III (TRANSCEND) trial (N=120) assessed setmelanotide (n=81: 33 adults & 48 pediatric) vs PBO (n= 39) for acquired hypothalamic obesity in 49 adults & 71 pediatric pts; additional arm of 12 Japanese pts is ongoing, with topline data expected by Q1’26. FDA & EMA filings to be completed by Q3’25
- Trial met its 1EP with a -16.5% vs +3.3% mean BMI change at 52wks., showing -19.2% & -20.2% PBO-adjusted BMI reductions in adult & pediatric pts, respectively. Overall, 80% of treated pts achieved ≥5% BMI reduction
- In 2EPs, 83% of adults & pediatric pts had ≥5% BMI or ≥0.2 BMI Z-score decrease, respectively, while pts (n=81; ≥12yrs.) saw a -1.4 reduction in weekly average daily maximal hunger score vs PBO
Ref: Rhythm Pharmaceuticals | Image: Rhythm Pharmaceuticals
Related News:- Rhythm Pharmaceuticals Reports the US FDA’s Approval of Imcivree (Setmelanotide) for Patients as Young as 2 Years Old
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
