Phase 3 randomized double-blind placebo-controlled study of setmelanotide in patients with MC4R pathway gene defects

Phase 3, randomised, double-blind trial in monogenic obesity and obesity comparing Setmelanotide with Placebo (2 arms). Primary endpoints: Proportion of obese patients who respond to setmelanotide at 52 weeks and Change in body weight from baseline to 52 weeks of setmelanotide treatment. Started Sep 2021; status: active.