hrp0094fc2.2 | Fat, Metabolism and Obesity | ESPE2021

Phase 3 Trial of Setmelanotide in Participants With Bardet-Biedl Syndrome: Placebo-Controlled Results

Argente Jesus , Clement Karine , Dollfus Helene , Han Joan , Haqq Andrea , Martos-Moreno Gabriel , Mittleman Robert , Stewart Murray , Webster Matt , Yanovski Jack , Yuan Guojun , Haws Robert ,

Background: In a Phase 3 trial in participants with obesity due to Bardet-Biedl syndrome (BBS) and Alström syndrome, setmelanotide was associated with significant reduction from baseline in body weight and hunger at Week 52 (primary endpoint), with outcomes driven by responses in individuals with BBS.Methods: In the same trial (NCT03746522), individuals with BBS or Alström syndrome were randomized and received ...