{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T20:02:19Z","timestamp":1791576139881,"version":"4.3.4"},"reference-count":13,"publisher":"S. Karger AG","issue":"3","license":[{"start":{"date-parts":[[2022,1,1]],"date-time":"2022-01-01T00:00:00Z","timestamp":1640995200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.karger.com\/Services\/SiteLicenses"},{"start":{"date-parts":[[2022,1,1]],"date-time":"2022-01-01T00:00:00Z","timestamp":1640995200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.karger.com\/Services\/SiteLicenses"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Horm Res Paediatr"],"published-print":{"date-parts":[[2022]]},"abstract":"<jats:p>&lt;b&gt;&lt;i&gt;Introduction:&lt;\/i&gt;&lt;\/b&gt; Somatrogon is a long-acting recombinant human growth hormone being developed as a once-weekly treatment for children with growth hormone deficiency (GHD). The objective of this phase 3 study (NCT03874013) was to compare the efficacy and safety of once-weekly somatrogon with once-daily Genotropin in Japanese children with GHD. &lt;b&gt;&lt;i&gt;Methods:&lt;\/i&gt;&lt;\/b&gt; In this open-label, randomized, active-controlled study, 44 prepubertal Japanese children with GHD (boys: 3 to &amp;#x3c;11 years; girls: 3 to &amp;#x3c;10 years) were randomized 1:1 to receive once-weekly somatrogon or once-daily Genotropin (0.025 mg\/kg\/day) for 12 months. Dose escalation for somatrogon-treated subjects occurred in the first 6 weeks (0.25, 0.48, and 0.66 mg\/kg\/week; 2 weeks each) with the remaining 46 weeks at a dose of 0.66 mg\/kg\/week. The study\u2019s primary endpoint was annualized height velocity (HV) at 12 months. &lt;b&gt;&lt;i&gt;Results:&lt;\/i&gt;&lt;\/b&gt; Baseline characteristics were similar between treatment groups. Compared with Genotropin-treated subjects, somatrogon-treated subjects had higher least-squares mean HV at 12 months (9.65 cm\/year vs. 7.87 cm\/year). Once-weekly somatrogon was concluded as being comparable to once-daily Genotropin as the mean treatment difference (somatrogon-Genotropin) in HV was +1.79 cm\/year (95% confidence interval, 0.97\u20132.61), which was greater than the preestablished margin (\u22121.8 cm\/year). For both treatment groups, most adverse events were mild to moderate in severity and a similar proportion of subjects reported injection-site pain, although the somatrogon group reported more painful injections. &lt;b&gt;&lt;i&gt;Conclusion:&lt;\/i&gt;&lt;\/b&gt; In prepubertal Japanese children with GHD, once-weekly somatrogon was comparable to once-daily Genotropin in terms of annualized (12-month) HV. Both treatments had similar safety and tolerability profiles.<\/jats:p>","DOI":"10.1159\/000524600","type":"journal-article","created":{"date-parts":[[2022,4,13]],"date-time":"2022-04-13T17:00:31Z","timestamp":1649869231000},"page":"275-285","source":"Crossref","is-referenced-by-count":44,"title":["Efficacy and Safety of Once-Weekly Somatrogon Compared with Once-Daily Somatropin (Genotropin\u00ae) in Japanese Children with Pediatric Growth Hormone Deficiency: Results from a Randomized Phase 3 Study"],"prefix":"10.1159","volume":"95","author":[{"given":"Reiko","family":"Horikawa","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshiaki","family":"Tanaka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yukihiro","family":"Hasegawa","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8945-4775","authenticated-orcid":false,"given":"Tohru","family":"Yorifuji","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Ng","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ron G.","family":"Rosenfeld","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuko","family":"Hoshino","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akifumi","family":"Okayama","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daisuke","family":"Shima","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7029-1542","authenticated-orcid":false,"given":"Roy","family":"Gomez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aleksandra","family":"Pastrak","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Orlando","family":"Castellanos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"127","published-online":{"date-parts":[[2022,4,13]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ghir.2019.12.002"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.1016\/j.beem.2016.11.004"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0206009"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1016\/j.ghir.2003.10.001"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-017-1529-1"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.2147\/PPA.S268972"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1155\/2011\/275063"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.89.10.4304"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.414"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.1002\/cpt.61"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.17458\/per.vol14.2017.t.internationalcomparison"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.1159\/000470842"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.1159\/000493211"}],"container-title":["Hormone Research in Paediatrics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.karger.com\/Article\/Pdf\/524600","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.karger.com\/Article\/Pdf\/524600","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,23]],"date-time":"2025-04-23T12:04:15Z","timestamp":1745409855000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/000524600"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022]]},"references-count":13,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2022,8,4]]},"published-print":{"date-parts":[[2022,8,11]]}},"URL":"https:\/\/doi.org\/10.1159\/000524600","archive":["Portico"],"relation":{"is-supplemented-by":[{"id-type":"doi","id":"10.6084\/m9.figshare.19590721","asserted-by":"subject"}]},"ISSN":["1663-2818","1663-2826"],"issn-type":[{"value":"1663-2818","type":"print"},{"value":"1663-2826","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022]]}}}