Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 26-week randomized, controlled trial.

ABSTRACT: OBJECTIVE:Somapacitan is a reversible albumin-binding growth hormone (GH) derivative, developed for once-weekly administration. This study aimed to evaluate the safety of once-weekly somapacitan vs once-daily Norditropin®. Local tolerability and treatment satisfaction were also assessed. DESIGN:26-week randomized, controlled phase 3 safety and tolerability trial in six countries (Nbib2382939). METHODS:Male or female patients aged 18-79 years with adult GH deficiency (AGHD), treated with once-daily GH for ≥6 months, were randomized to once-weekly somapacitan (n = 61) or once-daily Norditropin (n = 31) administered subcutaneously by pen. Both treatments were dose titrated for 8 weeks to achieve insulin-like growth factor I (IGF-I) standard deviation score (SDS) levels within the normal range

SUBMITTER: Johannsson G 

PROVIDER: S-EPMC5920019 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature