Open-label, multicenter, randomized, active-controlled, study in prepubertal children with GH deficiency to assess efficacy and safety of NGENLA once weekly versus GENOTROPIN® (somatropin) for injection once daily after 12 months of treatment.^1,2

Phase 2, open-label, randomized, dose-finding, and safety study with yearly extension in prepubertal patients with GH deficiency. Fifty-three patients were randomized and treated with one of 3 doses of once weekly somatrogon (0.25 mg/kg/week [n=13], 0.48 mg/kg/week [n=15], or 0.66 mg/kg/week [n=14]) or GENOTROPIN administered once daily (0.034 mg/kg/day [n= 11]). Patients who completed 12 months of active treatment in the main study period remained eligible for inclusion in the open-label extension study. The open-label extension followed patients on NGENLA for up to 5 additional years; in years 2 and beyond, all patients were transitioned to NGENLA at 0.66 mg/kg/week.^3,4