Camurus AB (publ) announced that the company's license partner Rhythm Pharmaceuticals has dosed the first patients in a Phase 3 trial evaluating weekly setmelanotide subcutaneous depot in patients six years of age and older with a rare genetic disease of obesity. The Phase 3 trial is a randomized, double-blind switch trial in patients with obesity due to biallelic or heterozygous proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1) or leptin receptor (LEPR) genetic variants or a clinical diagnosis of Bardet-Biedl Syndrome (BBS) with genetic confirmation, who were previously enrolled in Rhythm's long-term, open-label daily setmelanotide extension trial. The trial is expected to enroll 30 patients, randomized 1:1 to receive either once weekly setmelanotide and once daily placebo, or once daily setmelanotide and once weekly placebo for 13 weeks.

Following the 13-week randomized treatment period, the trial will crossover to an open-label, 13-week study in which all patients will receive once-weekly setmelanotide. The primary efficacy endpoint is proportion of patients with no weight gain.