Endocrine Abstracts

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...

Growth hormone deficiency (GHD) in children is a rare, aetiologically diverse condition that results in growth failure and short stature. Inadequate response to two different growth hormone stimulation tests (GHST) is required for the diagnosis of GHD. Macimorelin acetate, a potent, orally administered growth hormone (GH) secretagogue, is approved by the FDA and EMA for the diagnosis of adult GHD. Study AEZS-130-P01 is the first of two studies to investigate macimorelin acetat...