biostudies-literatureUnknown107(5)Savendahl LNovo Nordisk<h4>Context</h4>Current GH therapy requires daily injections, which can be burdensome. Somapacitan is a long-acting GH derivative in development for treatment of GH deficiency (GHD).<h4>Objective</h4>Evaluate the efficacy, safety, and tolerability of once-weekly somapacitan after 3 years of treatment.<h4>Design</h4>A multicenter, randomized, controlled, phase 2 study comparing somapacitan and once-daily GH for 156 weeks (NCT02616562).<h4>Setting</h4>Twenty-nine sites in 11 countries.<h4>Patients</h4>Fifty-nine children with GHD randomized (1:1:1:1) and exposed to treatment. Fifty-three children completed the 3-year period.<h4>Interventions</h4>Patients received somapacitan (0.04 [n = 14], 0.08 [n = 15], or 0.16 [n = 14] mg/kg/wk) or daily GH (n = 14) (0.034 mg/kg/d, equivalent to 0.238 mg/The Journal of clinical endocrinology and metabolism1357-1367https://www.ebi.ac.uk/biostudies/studies/S-EPMC9016428biostudies-literatureEffective GH Replacement With Once-weekly Somapacitan vs Daily GH in Children with GHD: 3-year Results From REAL 3.PMC9016428Battelino TBrod MSaenger PSavendahl LHojby Rasmussen MHorikawa RfalseEffective GH Replacement With Once-weekly Somapacitan vs Daily GH in Children with GHD: 3-year Results From REAL 3.<h4>Context</h4>Current GH therapy requires daily injections, which can be burdensome. Somapacitan is a long-acting GH derivative in development for treatment of GH deficiency (GHD).<h4>Objective</h4>Evaluate the efficacy, safety, and tolerability of once-weekly somapacitan after 3 years of treatment.<h4>Design</h4>A multicenter, randomized, controlled, phase 2 study comparing somapacitan and once-daily GH for 156 weeks (NCT02616562).<h4>Setting</h4>Twenty-nine sites in 11 countries.<h4>Patients</h4>Fifty-nine children with GHD randomized (1:1:1:1) and exposed to treatment. Fifty-three children completed the 3-year period.<h4>Interventions</h4>Patients received somapacitan (0.04 [n = 14], 0.08 [n = 15], or 0.16 [n = 14] mg/kg/wk) or daily GH (n = 14) (0.034 mg/kg/d, equivalent to 0.238 mg/2022-01-01T00:00:00Z2022 Apr2025-04-04T19:32:02.689Z2025-02-19T02:58:03.413ZS-EPMC90164283496445810.1210/clinem/dgab928