SUN-247 Once-Weekly Somapacitan in Childhood Growth Hormone Deficiency: Efficacy and Safety Results of a Randomized, Open-Label, Controlled Phase 2 Trial (REAL 3)

ABSTRACT: Abstract Background: Growth hormone deficiency (GHD) requires long-term daily injections with GH replacement therapy and is associated with considerable treatment burden. Somapacitan is a long-acting GH derivative being developed for once-weekly dosing in adults and children with GHD. A well-established protraction method, successfully used to extend the half-life of insulin and glucagon-like peptide (GLP)-1, has been applied in developing somapacitan: an albumin-binding moiety (1.3 kDa) is attached to a single amino acid substitution in the GH molecule (22 kDa). Objective: To evaluate the efficacy, safety, and tolerability of three once-weekly somapacitan doses, compared with Norditropin®, a daily GH. Methods: This multicenter, open-label, randomized, controlled phase 2 study (ClinicalTri

SUBMITTER: Savendahl L 

PROVIDER: S-EPMC6552843 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature