{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T02:35:55Z","timestamp":1789785355282,"version":"4.0.1"},"reference-count":38,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2026,2,19]],"date-time":"2026-02-19T00:00:00Z","timestamp":1771459200000},"content-version":"vor","delay-in-days":18,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004191","name":"Novo Nordisk","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004191","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,2,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Daily growth hormone (GH) injections restore normal growth and improve psychological outcomes in children with idiopathic short stature (ISS) but treatment burden is significant. The objective of this study is to demonstrate efficacy and safety of once-weekly somapacitan, a long-acting GH, in children with ISS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>REAL8 (ClinicalTrials.gov: NCT05330325) is a global, randomized, open-labelled, active-comparator, phase 3 basket study including 4 non-GH deficiency indications comprising a 52-week main phase and 104-week extension. Here, we present 52-week results from the REAL8 ISS study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Eighty-eight pre-pubertal, treatment-naive children with ISS at clinics in 20 countries were randomized 2:1 to somapacitan .24\u2005mg\/kg\/week or daily GH 0.050\u2005mg\/kg\/day, both administered subcutaneously. Eighty-five children completed the main 52-week treatment period.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Observed mean height velocity, HV, (SD) at week 52 was 10.2 (1.7) and 10.6 (1.6) cm\/year for somapacitan and daily GH groups, respectively (estimated treatment difference [ETD]: \u22120.3\u2005cm\/year [-1.00;0.42]95%CI, non-inferiority confirmed). Safety profiles were similar (somapacitan: 191 events in 47 (79.7%) participants, daily GH: 87 events in 22 (78.6%) participants) with most adverse events (AEs) mild and unlikely related to study product. Disease and treatment burden questionnaires presented favourable results.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Similar efficacy and safety were confirmed for once-weekly somapacitan versus daily GH in treatment-na\u00efve children with ISS, with favourable patient-reported outcome measures, setting the ground for future treatment for ISS with a once-weekly option.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical study registration<\/jats:title>\n                    <jats:p>NCT05330325<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ejendo\/lvag027","type":"journal-article","created":{"date-parts":[[2026,2,11]],"date-time":"2026-02-11T12:49:38Z","timestamp":1770814178000},"page":"242-253","source":"Crossref","is-referenced-by-count":2,"title":["Somapacitan in children with idiopathic short stature: a randomized controlled phase 3 study"],"prefix":"10.1093","volume":"194","author":[{"given":"Jennifer","family":"Abuzzahab","sequence":"first","affiliation":[{"name":"Department of Endocrinology, The McNeely Pediatric Diabetes Center, Children's Minnesota , St. Paul, MN 55102 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4890-0262","authenticated-orcid":false,"given":"Andrew","family":"Dauber","sequence":"additional","affiliation":[{"name":"Division of Endocrinology, Children's National Hospital , Washington, District of Columbia 20010 ,","place":["United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2210-0366","authenticated-orcid":false,"given":"Michael","family":"H\u00f8jby","sequence":"additional","affiliation":[{"name":"Research & Development, Novo Nordisk A\/S , S\u00f8borg 2860 ,","place":["Denmark"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kamil","family":"Soltysik","sequence":"additional","affiliation":[{"name":"Research & Development, Novo Nordisk A\/S , S\u00f8borg 2860 ,","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"}]},{"given":"Philip G","family":"Murray","sequence":"additional","affiliation":[{"name":"Division of Developmental Biology and Medicine, Faculty of Biology, Medicine and Health, University of Manchester and Manchester Academic Health Science Centre , Manchester M13 9WL ,","place":["United Kingdom"]},{"name":"Department of Paediatric Endocrinology, Royal Manchester Children's Hospital , Manchester M13 9WL ,","place":["United Kingdom"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Moshe","family":"Phillip","sequence":"additional","affiliation":[{"name":"Institute for Endocrinology and Diabetes, Schneider Children's Medical Center of Israel , Petah Tikva 3VQ9+54 ,","place":["Israel"]},{"name":"Faculty of Medical and Health Sciences, Tel-Aviv University , Tel-Aviv 4R84+M7 ,","place":["Israel"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0273-4732","authenticated-orcid":false,"given":"Tadej","family":"Battelino","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, Diabetes and Metabolism, University Children's Hospital, University Medical Center Ljubljana and Faculty of Medicine, University of Lubljana , Ljubljana 1000 ,","place":["Slovenia"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2026,2,19]]},"reference":[{"issue":"11","key":"2026030204015588000_lvag027-B1","doi-asserted-by":"publisher","first-page":"4210","DOI":"10.1210\/jc.2008-0509","article-title":"Consensus statement on the diagnosis and treatment of children with idiopathic short stature: a summary of the Growth Hormone Research Society, the Lawson Wilkins Pediatric Endocrine Society, and the European Society for Paediatric Endocrinology Workshop","volume":"93","author":"Cohen","year":"2008","journal-title":"J Clin Endocrinol Metab"},{"issue":"7","key":"2026030204015588000_lvag027-B2","doi-asserted-by":"publisher","first-page":"502","DOI":"10.1056\/NEJM199902183400702","article-title":"Effect of growth hormone treatment on adult height of children with idiopathic short stature. 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