Study design
obesity, BBS
OBESITY
A multicenter Phase 3 trial that included a randomized, double-blind, placebo-controlled period evaluated 52 weeks of treatment with setmelanotide in patients with BBS and obesity (ClinicalTrials.gov identifier: NCT03746522) [Patients were randomized to receive either setmelanotide or placebo during a 14-week, double-blind period with a dose escalation to 3.0 mg of setmelanotide (or placebo equivalent), followed by open-label setmelanotide for a total of ≥ 52 weeks setmelanotide treatment [