Results 21 to 30 of about 396 (132)

Somapacitan in Children Born SGA: 52-Week Efficacy, Safety, and IGF-I Response Results From the Phase 2 REAL5 Study. [PDF]

J Clin Endocrinol Metab
Abstract Context Somapacitan, a once-weekly reversible albumin-binding growth hormone (GH) derivative, is evaluated in short children born small for gestational age (SGA). Objective Evaluate efficacy, safety ...
Juul A, Backeljauw P, Højby M, Frystyk J, Kawai M, Kildemoes RJ, Lemminger AK, Linglart A, Zuckerman-Levin N, Horikawa R.   +9 more
europepmc   +4 more sources

Somapacitan in children born small for gestational age: a randomized controlled phase 3 trial

European Journal of Endocrinology
Abstract Objective Short stature in children born small for gestational age (SGA) is treated with daily injections of recombinant growth hormone (GH), a significant treatment burden. The objective of this study is to demonstrate the efficacy and safety of once-weekly somapacitan, a long-acting ...
Linglart, Agnès, Böttcher, Volker, Højby, Michael, Soltysik, Kamil, Longui, Carlos Alberto, Silverman, Lawrence, Kashimada, Kenichi   +6 more
openaire   +4 more sources

Somapacitan in children born small for gestational age: a multi-centre, open-label, controlled phase 2 study

European Journal of Endocrinology, 2023
Abstract Objective Investigate efficacy, safety, and tolerability of 3 once-weekly somapacitan doses compared with daily growth hormone (GH) administration in short children born small for gestational age (SGA). Design
Anders Juul, Philippe Backeljauw, Michael Højby, Masanobu Kawai, Rasmus Juul Kildemoes, Agnès Linglart, Nehama Zuckerman-Levin, Reiko Horikawa   +7 more
openaire   +4 more sources

Long-acting growth hormone in the treatment of growth hormone deficiency in children: a systematic literature review and network meta-analysis

Scientific Reports
The purpose of this study is to compare the relative efficacy and safety of long-acting growth hormone (LAGH) as a growth hormone replacement therapy in prepubertal children with growth hormone deficiency (GHD).
Jianfang Zhu, Ke Yuan, Sunita Rana, Satya Lavanya Jakki, Amit Subray Bhat, Li Liang, Chunlin Wang   +6 more
doaj   +2 more sources

Gene Expression Signatures Predict First-Year Response to Somapacitan Treatment in Children With Growth Hormone Deficiency.

J Clin Endocrinol Metab, 2023
Abstract Context The pretreatment blood transcriptome predicts growth response to daily growth hormone (GH) therapy with high accuracy. Objective Investigate response prediction using pretreatment transcriptome in children with GH ...
Garner T, Clayton P, Højby M, Murray P, Stevens A.   +4 more
europepmc   +6 more sources

Somapacitan, a once‐weekly reversible albumin‐binding GH derivative, in children with GH deficiency: A randomized dose‐escalation trial

Clinical Endocrinology, 2017
SummaryObjectiveTo evaluate the safety, local tolerability, pharmacodynamics and pharmacokinetics of escalating single doses of once‐weekly somapacitan, a reversible, albumin‐binding GH derivative, vs once‐daily GH in children with GH deficiency (GHD).DesignPhase 1, randomized, open‐label, active‐controlled, dose‐escalation trial (NCT01973244 ...
Battelino, Tadej, Rasmussen, Michael Højby, De Schepper, Jean, Zuckerman-Levin, Nehama, Gucev, Zoran, Sävendahl, Lars, Schwitzgebel Luscher, Valérie, Zumsteg, Urs, NN8640-4042 Study Group   +8 more
openaire   +5 more sources

Once-weekly somapacitan enhances linear growth in girls with Turner syndrome: a randomized controlled phase 3 study

The Journal of Clinical Endocrinology & Metabolism
Abstract Context Daily GH injections promote growth in girls with Turner syndrome (TS), but treatment burden is considerable. Objective This study aims to evaluate 52-week efficacy and safety of once-weekly ...
Nelly Mauras, Claudia Boettcher, Michael Højby, Kamil Soltysik, Alexander A L Jorge, Kenichi Kashimada, Agnès Linglart, Xiaoping Luo, Philip G Murray, Philippe Backeljauw   +9 more
core   +4 more sources

What do we do now that the long-acting growth hormone is here?

Frontiers in Endocrinology, 2022
In standard 52-week phase III clinical trials, once weekly lonapegsomatropin, somatrogon and somapacitan have been found to yield non-inferior height velocities and similar safety profiles to daily GH (DGH) in children with pediatric growth hormone ...
Bradley S. Miller
doaj   +1 more source

Safety and efficacy of weekly somapacitan for growth hormone deficiency in children: A 72-week observational study. [PDF]

Saudi Med J
To assess the effectiveness and safety of somapacitan, a long-acting growth hormone analog, as a promising treatment to improve adherence in pediatric growth hormone deficiency (GHD) management.The observational study included 184 children diagnosed with GHD.
Al-Agha AE, Aljefri HM, Kafi SE, Alamri AS, Alghamdi AA.   +4 more
europepmc   +3 more sources

Growth hormone receptor agonists and antagonists: From protein expression and purification to long‐acting formulations

Protein Science, Volume 32, Issue 9, September 2023., 2023
Abstract Recombinant human growth hormone (rhGH) and GH receptor antagonists (GHAs) are used clinically to treat a range of disorders associated with GH deficiency or hypersecretion, respectively. However, these biotherapeutics can be difficult and expensive to manufacture with multiple challenges from recombinant protein generation through to the ...
Yue Wang, Minah Kim, Chantal Buckley, Heather D. Maynard, Ries J. Langley, Jo K. Perry   +5 more
wiley   +1 more source