hrp0092p1-363 | GH and IGFs (2) | ESPE2019

Metabolism of Somapacitan, a Long-Acting Growth Hormone Derivative, in Human Subjects

Damholt Birgitte B , Bjelke Mads , Helleberg Hans , Rasmussen Michael H

Background: Somapacitan is a reversible albumin-binding growth hormone (GH) derivative developed for once-weekly administration in patients with GH deficiency (GHD). It consists of a human GH backbone, similar to endogenous human GH, with one amino acid substitution, attached to an albumin binder via a linker chain.Objective: Absorption, metabolism and excretion (AME) of somapacitan were investigated in a Phase 1 trial (...

hrp0092p1-371 | Growth and Syndromes (to include Turner Syndrome) (2) | ESPE2019

Growth Hormone Deficiency (GHD): Assessing Parent Burden for Child Growth Hormone Deficiency Treatment: The Growth Hormone Deficiency - Parent Treatment Burden Measure (GHD-PTB)

Brod Meryl , Rasmussen Michael Højby , Vad Knud , Alolga Suzanne , Bedoin Jacques

Background: Treatment for child GHD requires daily injections, which can be painful and disruptive. For most children, these injections are administered by an adult, usually their parent. Unfortunately, little is known about the burden that a child's treatment places on a parent. The GHD-PTB was developed according to FDA/EMA guidances to address this gap. Items were based on qualitative interviews of 31 parents of children with GHD, ages 4 to <13 year...

hrp0092fc14.5 | GH and IGF5 | ESPE2019

OOnce-weekly Somapacitan vs Daily Growth Hormone (Norditropin®) in Childhood Growth Hormone Deficiency: One-year Results from a Randomised Phase 2 Trial

Sävendahl Lars , Battelino Tadej , Horikawa Reiko , Juul Rasmus Vestergaard , Rasmussen Michael Højby , Saenger Paul

Daily injections are required for human growth hormone (GH) replacement therapy. Somapacitan is a long-acting GH derivative being developed for once-weekly dosing in adults and children using a proven protraction method, currently successfully in use to extend the half-life of insulin and glucagon-like peptide 1.To evaluate the efficacy and safety of three different once-weekly somapacitan doses compared with Norditropin®, a daily GH, ove...