{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,14]],"date-time":"2026-10-14T11:15:40Z","timestamp":1791976540713,"version":"4.4.0"},"reference-count":35,"publisher":"The Endocrine Society","issue":"7","license":[{"start":{"date-parts":[[2022,4,11]],"date-time":"2022-04-11T00:00:00Z","timestamp":1649635200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Pfizer Inc"},{"DOI":"10.13039\/100015851","name":"OPKO Health","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100015851","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,6,16]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Context<\/jats:title>\n                    <jats:p>Somatrogon is a long-acting recombinant human growth hormone (rhGH) in development for once-weekly treatment of children with growth hormone deficiency (GHD).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>We aimed to compare the efficacy and safety of once-weekly somatrogon with once-daily somatropin in prepubertal children with GHD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this 12-month, open-label, randomized, active-controlled, parallel-group, phase 3 study, participants were randomized 1:1 to receive once-weekly somatrogon (0.66 mg\/kg\/week) or once-daily somatropin (0.24 mg\/kg\/week) for 12 months. A total of 228 prepubertal children (boys aged 3-11 years, girls aged 3-10 years) with GHD, impaired height and height velocity (HV), and no prior rhGH treatment were randomized and 224 received \u22651 dose of study treatment (somatrogon: 109; somatropin: 115). The primary endpoint was annualized HV at month 12.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>HV at month 12 was 10.10 cm\/year for somatrogon-treated subjects and 9.78 cm\/year for somatropin-treated subjects, with a treatment difference (somatrogon-somatropin) of 0.33 (95% CI: \u22120.24, 0.89). The lower bound of the 2-sided 95% CI was higher than the prespecified noninferiority margin (\u22121.8 cm\/year), demonstrating noninferiority of once-weekly somatrogon vs daily somatropin. HV at month 6 and change in height standard deviation score at months 6 and 12 were similar between both treatment groups. Both treatments were well tolerated, with a similar percentage of subjects experiencing mild to moderate treatment-emergent adverse events in both groups (somatrogon: 78.9%, somatropin: 79.1%).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The efficacy of once-weekly somatrogon was noninferior to once-daily somatropin, with similar safety and tolerability profiles. (ClinicalTrials.gov no. NCT02968004).<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1210\/clinem\/dgac220","type":"journal-article","created":{"date-parts":[[2022,4,11]],"date-time":"2022-04-11T12:48:17Z","timestamp":1649681297000},"page":"e2717-e2728","source":"Crossref","is-referenced-by-count":115,"title":["Efficacy and Safety of Weekly Somatrogon vs Daily Somatropin in Children With Growth Hormone Deficiency: A Phase 3 Study"],"prefix":"10.1210","volume":"107","author":[{"given":"Cheri L","family":"Deal","sequence":"first","affiliation":[{"name":"Centre de recherche CHU Ste-Justine, Universit\u00e9 de Montr\u00e9al , Montr\u00e9al , Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joel","family":"Steelman","sequence":"additional","affiliation":[{"name":"Cook Children\u2019s Medical Center , Fort Worth, TX , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elpis","family":"Vlachopapadopoulou","sequence":"additional","affiliation":[{"name":"Children\u2019s Hospital P. & A. 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