Endocrine Abstracts

Somapacitan is a long-acting growth hormone (GH) intended for once-weekly subcutaneous administration. As for GH, the mechanism of action of somapacitan is either directly or indirectly via insulin-like growth factor I (IGF-I). A PK/PD model of somapacitan was developed from the pharmacokinetics (PK) and IGF-I levels from three phase 1 trials data: a single dose/multiple dose trial (0.02–0.24 mg/kg per week) in healthy adults, a multiple dose trial in adults with growth h...

Background: Somapacitan is a reversible albumin-binding growth hormone (GH) derivative developed for once-weekly administration. Non-covalent binding to endogenous albumin delays somapacitan elimination, prolonging its half-life and duration of action. Somapacitan is not cleared by a specific organ, but impaired hepatic function may affect its pharmacokinetics. We report data from an open-label, parallel group, phase I trial (NCT03212131) investigating the pharmacokinetic and ...

Background: Somapacitan is a reversible albumin-binding growth hormone (GH) derivative developed for once-weekly administration that acts directly or indirectly via insulin-like growth factor I (IGF-I). As renal impairment may affect drug metabolism and excretion, we report data from an open-label, parallel group, phase I trial (NCT03186495) investigating the pharmacokinetic and pharmacodynamic properties, and safety of somapacitan in individuals with varying degrees of impair...

Somapacitan is a long-acting, reversible albumin-binding growth hormone (GH) derivative. The objective of this trial was to evaluate the safety, efficacy and treatment satisfaction of onceweekly somapacitan versus daily GH (Norditropin) over 52 weeks in Japanese patients with adult GH deficiency (AGHD). This was a phase 3, multicentre, randomised, open-label, parallel-group, active-controlled trial (NCT03075644). Patients previously treated with GH were randomised 1:3 to daily...

In patients with adult growth hormone deficiency (AGHD), the dose of growth hormone (GH) replacement is individualised based on clinical outcome, insulin-like growth factor-I (IGF-I) levels and adverse reactions. The aim of this analysis was to characterise dose–IGFI–response for somapacitan, a long-acting reversible albumin-binding GH derivative, and to derive expected IGF-I levels for various starting doses. Somapacitan dose–IGF-I–response analysis wa...

Somapacitan is a long-acting growth hormone (GH) derivative designed for once-weekly subcutaneous administration. Correct assessment of insulin-like growth factor-I (IGF-I) levels is essential during treatment of GH deficiency (GHD) and must account for fluctuations over a dosing interval. We evaluated whether reliable estimates of weekly mean and peak IGF-I could be obtained from a single IGF-I sample. A population pharmacokinetic/pharmacodynamic model was available from phar...

Background: Following the 34-week, double-blind, placebo-controlled main phase of REAL-1 (NCT02229851), this open-label trial extension evaluated efficacy and safety of somapacitan in patients aged 23–79 years with AGHD, for an additional 52 weeks (8 weeks’ dose titration followed by 44 weeks’ fixed dose treatment; 86 weeks’ treatment in total).Methods: Patients completing the main trial entered the extension: 1) somapacitan-treated p...

Somapacitan is a once-weekly, long-acting growth hormone (GH) derivative approved for the treatment of adult GH deficiency (AGHD). Our objective was to evaluate the effects of somapacitan on glucose metabolism compared with daily GH or placebo in patients with AGHD using data from three previously published phase 3 trials: REAL 1 (NCT02229851), REAL 2 (NCT02382939) and REAL Japan (NCT03075644). REAL 1 was a randomised, placebo-controlled (double-blind) and active-controlled (o...