{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,31]],"date-time":"2026-08-31T14:01:51Z","timestamp":1788184911326,"version":"build-2803163510"},"reference-count":45,"publisher":"The Endocrine Society","issue":"5","license":[{"start":{"date-parts":[[2021,12,29]],"date-time":"2021-12-29T00:00:00Z","timestamp":1640736000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/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":[[2022,4,19]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Context<\/jats:title>\n                    <jats:p>Current GH therapy requires daily injections, which can be burdensome. Somapacitan is a long-acting GH derivative in development for treatment of GH deficiency (GHD).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Evaluate the efficacy, safety, and tolerability of once-weekly somapacitan after 3 years of treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>A multicenter, randomized, controlled, phase 2 study comparing somapacitan and once-daily GH for 156 weeks (NCT02616562).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>Twenty-nine sites in 11 countries.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients<\/jats:title>\n                    <jats:p>Fifty-nine children with GHD randomized (1:1:1:1) and exposed to treatment. Fifty-three children completed the 3-year period.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interventions<\/jats:title>\n                    <jats:p>Patients received somapacitan (0.04 [n = 14], 0.08 [n = 15], or 0.16 [n = 14] mg\/kg\/wk) or daily GH (n = 14) (0.034 mg\/kg\/d, equivalent to 0.238 mg\/kg\/wk) subcutaneously during the first year, after which all patients on somapacitan received 0.16 mg\/kg\/wk.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Main Outcome Measures<\/jats:title>\n                    <jats:p>Height velocity (HV) at year 3; changes from baseline in height SD score (HSDS), HVSDS, and IGF-I SDS.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The estimated treatment difference (95% CI) in HV for somapacitan 0.16\/0.16 mg\/kg\/wk vs daily GH at year 3 was 0.8 cm\/y (\u22120.4 to 2.1). Change in HVSDS from baseline to year 3 was comparable between somapacitan 0.16\/0.16 mg\/kg\/wk, the pooled somapacitan groups, and daily GH. A gradual increase in HSDS from baseline was observed for all groups. At year 3, mean HSDS was similar for the pooled somapacitan groups and daily GH. Change from baseline to year 3 in mean IGF-I SDS was similar across treatments.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Once-weekly somapacitan in children with GHD showed sustained efficacy over 3 years in all assessed height-based outcomes with similar safety and tolerability to daily GH. A plain language summary (1) is available for this study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial information<\/jats:title>\n                    <jats:p>This study has been registered at ClinicalTrials.gov, number NCT02616562 (REAL 3).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1210\/clinem\/dgab928","type":"journal-article","created":{"date-parts":[[2021,12,29]],"date-time":"2021-12-29T08:08:24Z","timestamp":1640765304000},"page":"1357-1367","source":"Crossref","is-referenced-by-count":52,"title":["Effective GH Replacement With Once-weekly Somapacitan vs Daily GH in Children with GHD: 3-year Results From REAL 3"],"prefix":"10.1210","volume":"107","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1067-4976","authenticated-orcid":false,"given":"Lars","family":"S\u00e4vendahl","sequence":"first","affiliation":[{"name":"Department of Women\u2019s and Children\u2019s Health, Karolinska Institutet and Pediatric Endocrinology Unit, Karolinska University Hospital, Solna 171 64, Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0273-4732","authenticated-orcid":false,"given":"Tadej","family":"Battelino","sequence":"additional","affiliation":[{"name":"University Medical Center Ljubljana, and Faculty of Medicine, University of Ljubljana, Ljubljana 1000, Slovenia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"H\u00f8jby Rasmussen","sequence":"additional","affiliation":[{"name":"Novo Nordisk, Clinical Drug Development, S\u00f8borg 2860, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Meryl","family":"Brod","sequence":"additional","affiliation":[{"name":"The Brod Group, Mill Valley, CA 94941, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Saenger","sequence":"additional","affiliation":[{"name":"NYU Langone Health, Mineola, NY 11501, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reiko","family":"Horikawa","sequence":"additional","affiliation":[{"name":"National Center for Child Health and Development, Tokyo 157-8535, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"80","published-online":{"date-parts":[[2021,12,29]]},"reference":[{"key":"2022041907542040100_CIT0001","article-title":"Plain language summary - Effective growth hormone replacement with once-weekly somapacitan versus daily growth hormone in children with growth hormone deficiency: 3-year results from REAL 3. figshare. 2022.","author":"S\u00e4vendahl"},{"issue":"6","key":"2022041907542040100_CIT0002","doi-asserted-by":"crossref","first-page":"361","DOI":"10.1159\/000452150","article-title":"Guidelines for growth hormone and insulin-like growth factor-I treatment in children and adolescents: growth hormone deficiency, idiopathic short stature, and primary insulin-like growth factor-I deficiency","volume":"86","author":"Grimberg","year":"2016","journal-title":"Horm. 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