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...

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...