{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T20:30:45Z","timestamp":1790195445564,"version":"4.1.0"},"reference-count":43,"publisher":"The Endocrine Society","issue":"4","license":[{"start":{"date-parts":[[2024,9,13]],"date-time":"2024-09-13T00:00:00Z","timestamp":1726185600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Novo Nordisk A\/S"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2025,3,17]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Context<\/jats:title>\n                    <jats:p>Somapacitan, a once-weekly reversible albumin-binding growth hormone (GH) derivative, is evaluated in short children born small for gestational age (SGA).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Evaluate efficacy, safety, tolerability as well as total and bioactive insulin-like growth factor I (IGF-I) response of once-weekly somapacitan compared to daily GH in children born SGA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>REAL5 is a randomized, multicenter, open-label, controlled phase 2 study comprising a 26-week main phase, a 26-week extension, and an ongoing 4-year safety extension (NCT03878446), conducted at 38 sites across 12 countries. A total of 62 GH-treatment-na\u00efve, prepubertal short children born SGA were randomized; 61 completed 52-weeks of treatment. Patients were randomized (1:1:1:1:1) to somapacitan (0.16, 0.20, or 0.24 mg\/kg\/week) or daily GH (0.035 or 0.067 mg\/kg\/day), all administered subcutaneously.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Estimated mean height velocity (HV; cm\/year) at week 52 was 8.5, 10.4, and 10.7 cm\/year for somapacitan 0.16, 0.20, and 0.24 mg\/kg\/week, respectively, and 9.3 and 11.2 cm\/year for daily GH 0.035 and 0.067 mg\/kg\/day, respectively. Dose-dependent increases in total IGF-I, as well as peak IGF-I bioactivity, were observed for both treatments and were similar between comparator groups. For somapacitan, exposure-response modeling indicated highest efficacy with 0.24 mg\/kg\/week after 52 weeks of treatment. Similar safety and tolerability were demonstrated across all groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>A sustained dose-dependent growth response was demonstrated for somapacitan after 52 weeks of treatment. Overall, somapacitan 0.24 mg\/kg\/week provides similar efficacy, safety, and tolerability, as well as comparable bioactive and total IGF-I response, as daily GH (0.067 mg\/kg\/day) in children born SGA.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1210\/clinem\/dgae616","type":"journal-article","created":{"date-parts":[[2024,9,13]],"date-time":"2024-09-13T00:26:27Z","timestamp":1726187187000},"page":"1086-1095","source":"Crossref","is-referenced-by-count":14,"title":["Somapacitan in Children Born SGA: 52-Week Efficacy, Safety, and IGF-I Response Results From the Phase 2 REAL5 Study"],"prefix":"10.1210","volume":"110","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0534-4350","authenticated-orcid":false,"given":"Anders","family":"Juul","sequence":"first","affiliation":[{"name":"Department of Growth and Reproduction, Copenhagen University Hospital\u2014Rigshospitalet , Copenhagen 2100 ,","place":["Denmark"]},{"name":"Department of Clinical Medicine, University of Copenhagen , 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Research, University of Southern Denmark , Odense 5230 ,","place":["Denmark"]},{"name":"Department of Endocrinology, Odense University Hospital , Odense 5000 ,","place":["Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4466-1559","authenticated-orcid":false,"given":"Masanobu","family":"Kawai","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology, Nutrition and Endocrinology, Osaka Women's and Children's Hospital , Izumi, Osaka 594-1101 ,","place":["Japan"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0965-9333","authenticated-orcid":false,"given":"Rasmus Juul","family":"Kildemoes","sequence":"additional","affiliation":[{"name":"Clinical Drug Development, Novo Nordisk A\/S , S\u00f8borg 2860 ,","place":["Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7929-7147","authenticated-orcid":false,"given":"Anders Krogh","family":"Lemminger","sequence":"additional","affiliation":[{"name":"Clinical Drug Development, Novo Nordisk A\/S , S\u00f8borg 2860 ,","place":["Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3455-002X","authenticated-orcid":false,"given":"Agn\u00e8s","family":"Linglart","sequence":"additional","affiliation":[{"name":"AP-HP, Universit\u00e9 Paris Saclay, INSERM, Service d\u2019Endocrinologie et Diab\u00e8te de l\u2019Enfant, H\u00f4pital Bic\u00eatre Paris Saclay , Le Kremlin-Bic\u00eatre 94270 ,","place":["France"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5372-8113","authenticated-orcid":false,"given":"Nehama","family":"Zuckerman-Levin","sequence":"additional","affiliation":[{"name":"Institute of 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