ESPE Yearbook of Paediatric Endocrinology

J Clin Endocrinol Metab, 2022. 107(5): p. 1357-1367. PMID: 34964458Brief Summary: This multicenter, randomized, controlled, phase 2 study compared the effects of once-weekly long-acting growth hormone (GH) somapacitan versus daily GH administered to GH-deficient (GHD) children over a period of 156 weeks. Efficacy estimates were height velocity (HV; cm/y) at year 3 and changes from baseline to end for height SDS, HV SDS, IGF-I SDS, and insulin-li...

To read the full abstract: J Clin Endocrinol Metab ;105(4):e1847–e1861.The REAL 3 multicenter randomized, controlled, double-blind phase 2 study evaluated the efficacy and safety of different doses of once-weekly Somapacitan, compared to conventional once-daily GH in 59 prepubertal GHD children. The treatment period lasted 26 weeks and an additional extension to 52 weeks. At week 26, height velocity (HV) was 7.8, 10.9 and 13.1 cm/year, resp...

Brief summary: This multicenter, randomized, controlled, phase 3 study compared the effects of long-acting GH (Somapacitan; 0.16 mg/kg/wk) with daily GH (Norditropin; 0.034 mg/kg/d), in GHD children. The trial was conducted over 52 weeks, followed by an ongoing 3-year single-group extension period. Similar efficacy and safety for somapacitan compared to daily GH was demonstrated over 52 weeks of treatment.Long-acting growth hormone (LAGH) formulations ha...