Results 31 to 40 of about 291 (113)

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, tolerability as well as ...
Juul A, Backeljauw P, Højby M, Frystyk J, Kawai M, Kildemoes RJ, Lemminger AK, Linglart A, Zuckerman-Levin N, Horikawa R.   +9 more
europepmc   +3 more sources

Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan [PDF]

The Journal of Clinical Endocrinology & Metabolism, 2020
Abstract Context Somapacitan is a long-acting growth hormone (GH) in development for once-weekly treatment of GH deficiency (GHD). Optimal monitoring of insulin-like growth factor-I (IGF-I) levels must account for weekly IGF-I fluctuations following somapacitan administration.
Rasmus Juul Kildemoes, Michael Højby Rasmussen, Henrik Agersø, Rune Viig Overgaard   +3 more
openaire   +2 more sources

Effect of Kidney or Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Somapacitan: Two Open-Label, Parallel-Group Trials [PDF]

Clinical Pharmacokinetics, 2021
Somapacitan is a long-acting growth hormone (GH) derivative being developed for once-weekly dosing in patients with GH deficiency (GHD). Our objective was to evaluate the impact of kidney or hepatic impairment on somapacitan exposure in adults.In two open-label, parallel-group, single-center, 6-week trials, eligible subjects (18-75 years of age, body ...
Birgitte Bentz Damholt, Sarah Louise Dombernowsky, Mette Dahl Bendtsen, Charlotte Bisgaard, Michael Højby Rasmussen   +4 more
openaire   +2 more sources

Somapacitan Is Effective and Well Tolerated in Chinese Children with Growth Hormone Deficiency: A Randomized Controlled Phase 3 Study. [PDF]

Horm Res Paediatr
Introduction: REAL6 is a randomized, multi-centre, open-labelled, active-controlled parallel group phase 3 trial (NCT04970654) investigating once-weekly somapacitan, a reversible albumin-binding growth hormone (GH) derivative, in Chinese children with GH deficiency (GHD). Methods: 110 treatment-naïve patients were randomized 2:1 to somapacitan (0.16 mg/
Fu J, Cheng X, Højby M, Gong C, Leunbach TL, Li Y, Wei H, Zhu Y, Zhang Y, Zhong Y, REAL6 study group.   +10 more
europepmc   +3 more sources

Similar safety and efficacy in previously treated adults with growth hormone deficiency randomized to once‐weekly somapacitan or daily growth hormone

Clinical Endocrinology, Volume 93, Issue 5, Page 620-628, November 2020., 2020
Abstract Objective Somapacitan is a long‐acting, reversible albumin‐binding growth hormone (GH) derivative in development. This study aimed to evaluate the safety and efficacy of once‐weekly somapacitan versus daily GH over 52 weeks in Japanese patients with adult growth hormone deficiency (AGHD). Design Phase 3, multicentre, randomized, parallel‐group,
Fumio Otsuka, Yutaka Takahashi, Shigeyuki Tahara, Yoshihisa Ogawa, Michael Højby Rasmussen, Koji Takano   +5 more
wiley   +1 more source

Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 26-week randomized, controlled trial [PDF]

European Journal of Endocrinology, 2018
Objective Somapacitan is a reversible albumin-binding growth hormone (GH) derivative, developed for once-weekly administration. This study aimed to evaluate the safety of once-weekly somapacitan vs once-daily Norditropin®. Local tolerability and treatment satisfaction were also assessed.
Gudmundur Johannsson, Ulla Feldt-Rasmussen, Ida Holme Håkonsson, Henrik Biering, Patrice Rodien, Shigeyuki Tahara, Andrew Toogood, Michael Højby Rasmussen, _ _, _ _, Henrik Biering, Wolfram Karges, Alexander Mann, Jens Sandahl Christiansen, Troels Krarup Hansen, Marianne Andersen, Ulla Feldt-Rasmussen, Sine Borresen, Patrice Rodien, Françoise Borson-Chazot, Véronique Kerlan, Bertrand Cariou, Bruno Verges, Shigeyuki Tahara, Akira Matsuno, Koji Takano, Tetsuya Tagami, Yutaka Takahashi, Toshikazu Takahashi, Masahiro Yamamoto, Gudmundur Johannsson, Charlotte Höybye, Eva-Marie Erfurth, William Drake, Claire Higham, Robert Murray, Andrew Toogood, Antonia Brooke   +37 more
openaire   +3 more sources

Spotlight on Lonapegsomatropin Once-Weekly Injection and Its Potential in the Treatment of Growth Hormone Deficiency in Pediatric Patients

Drug Design, Development and Therapy, 2022
Bradley S Miller,1 Kevin CJ Yuen2 1Pediatric Endocrinology, University of Minnesota Medical School, Minneapolis, MN, USA; 2Department of Neuroendocrinology and Neurology, Barrow Pituitary Center, University of Arizona College of Medicine and Creighton ...
Miller BS, Yuen KCJ
doaj  

Growth Response to Weekly Somapacitan Therapy in Children With GH Deficiency Is Related to GH Thresholds in GH Stimulation Testing. [PDF]

J Endocr Soc
Abstract Context The lack of a severity definition and standardized GH cutoff level for GH deficiency (GHD) diagnosis in children leads to ambiguity in the interpretation of GH stimulation tests and treatment recommendations. Objective
Backeljauw PF, Boettcher C, Højby M, Kelepouris N, Jeppesen ML, Mori J, Pietropoli A, Miller BS.   +7 more
europepmc   +3 more sources

Detection of the GH Analogue Redalsomatropin Alfa in Sports Drug Testing: Immunological Approaches and LC‐HRMS/MS

Drug Testing and Analysis, Volume 18, Issue 7, Page 811-820, July 2026.
After evaluating the compatibility of the GH analogue redalsomatropin alfa with approved doping control immunoassays for rhGH, it was implemented into the existing detection method for somatrogon employing affinity purification with GHR‐Fc‐conjugated magnetic beads, tryptic digestion, and LC‐HRMS/MS to allow for a specific and sensitive detection ...
Katja Walpurgis, Andreas Thomas, Jasmin Thelen, Bettina Majer, Maneera Al‐Jaber, Wadha Abushareeda, Mario Thevis   +6 more
wiley   +1 more source

A Comparison of Regional Decisions for Doses and Administrations of New Drugs: Concordance, Discordance, and Dependencies

Clinical Pharmacology &Therapeutics, Volume 119, Issue 5, Page 1350-1361, May 2026.
Regional differences in approved drug dosages and administration are shaped by complex factors, including clinical data, prior regulatory decisions, and region‐specific considerations. This study investigated how such factors are associated with variations in approved doses across the United States Food and Drug Administration (FDA), European Medicines
Sachiko Mita, Shunsuke Ono
wiley   +1 more source