hrp0086p2-p671 | Growth P2 | ESPE2016

Assessing Disease and Treatment Burden for Young Children with Growth Hormone Deficiency (GHD)

Brod Meryl , Wilkinson Lars , Alolga Suzanne Lessard , Hojbjerre Lise , Beck Jane , Rasmussen Michael Hojby

Background: Children with GHD, in addition to short stature, may experience physiological symptoms as well as social and emotional problems. Assessing these impacts is critical for understanding the extent of GHD burden and assessing treatment benefit. Since many children initiating treatment are too young to self-report information, we must rely on adult reporters. However, according to FDA guidelines and established measure development principles, adult reporter information ...

hrp0094fc9.3 | Growth Hormone and IGFs | ESPE2021

Once-weekly somapacitan versus daily growth hormone in growth hormone deficiency: 3 year efficacy and safety results from REAL 3, a randomised controlled phase 2 trial

Savendahl Lars , Battelino Tadej , Rasmussen Michael Hojby , Saenger Paul , Horikawa Reiko ,

Growth hormone (GH) replacement therapy currently requires daily subcutaneous injections. Somapacitan is a long-acting GH-derivative in development for once-weekly use in children with GH deficiency (GHD). A phase 2, multinational, randomised, open-label, controlled trial (NCT02616562) investigated the efficacy and safety of somapacitan compared with daily GH (Norditropin®). GH-treatment-naïve prepubertal children with GHD received 0.04 (n = 16), 0.08 (n...

hrp0089fc4.6 | GH & IGFs | ESPE2018

Absorption and Excretion of Somapacitan, a Long-Acting Growth Hormone (GH) Derivative

Rasmussen Michael Hojby , Damholt Birgitte Bentz , Helleberg Hans , Bjelke Mads , Suresh Swapna , Juul Rasmus Vestergaard , Hollensen Christian

Background: Somapacitan is a reversible albumin-binding growth hormone (GH) derivative in clinical development for once-weekly administration in patients with GH deficiency (GHD). Clinical data in healthy subjects, and adults and children with GHD showed that once-weekly somapacitan injections were well tolerated with no clinically significant safety or local tolerability issues. A sustained dose-dependent IGF-I response supports a once-weekly treatment regimen.<p class="a...

hrp0084fc7.4 | Growth-promoting therapies | ESPE2015

A Novel Reversible Albumin-Binding GH Derivative Possesses a Promising Once-Weekly Treatment Profile in Children with GH Deficiency

Zuckerman-Levin Nehama , Gucev Zoran , de Schepper Jean , Rasmussen Michael Hojby , Battelino Tadej , Olsen Minna Braendholt , Savendahl Lars

Background: GH administration restores normal growth in children with GH deficiency (GHD). However, current daily s.c. injection treatment regimens may be inconvenient leading to impaired adherence and subsequently suboptimal treatment outcomes. NNC0195-0092 is a novel, reversible albumin-binding GH developed for once-weekly administration.Objective and hypotheses: This was a randomised, open-label, active-controlled, dose-escalation trial (NCT01973244) ...

hrp0082p2-d1-420 | Growth Hormone | ESPE2014

S.c. Injections of a Reversible Albumin-Binding GH Derivative (NNC0195-0092) in Adult Subjects with GH Deficiency is Well Tolerated

Rasmussen Michael Hojby , Janukonyte Jurgita , Klose Marianne , Marina Djordje , Tanvig Mette , Nielsen Lene , Hoybye Charlotte , Andersen Marianne , Feldt-Rasmussen Ulla , Christiansen Jens

Background: Recombinant human GH (rhGH) is normally administered as a daily s.c. injection. NNC0195-0092 is a reversible albumin-binding GH derivative developed with the aim of reducing clearance and thereby extending the exposure. It has previously been demonstrated that NNC0195-0092 is well tolerated in healthy subjects with the potential for once weekly administration.Objective and hypotheses: In this trial NNC0195-0092 was administrated subcutaneousl...