{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,19]],"date-time":"2026-09-19T02:35:52Z","timestamp":1789785352740,"version":"4.0.1"},"reference-count":23,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2020,8,14]],"date-time":"2020-08-14T00:00:00Z","timestamp":1597363200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Endocrinology"],"published-print":{"date-parts":[[2020,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>Somapacitan is a long\u2010acting, reversible albumin\u2010binding growth hormone (GH) derivative in development. This study aimed to evaluate the safety and efficacy of once\u2010weekly somapacitan versus daily GH over 52\u00a0weeks in Japanese patients with adult growth hormone deficiency (AGHD).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Phase\u00a03, multicentre, randomized, parallel\u2010group, open\u2010label, active\u2010controlled trial (NCT03075644).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients<\/jats:title>\n                    <jats:p>Previously GH\u2010treated Japanese patients with AGHD were randomized 3:1 to somapacitan (n\u00a0=\u00a046) or daily GH (n\u00a0=\u00a016) for 20\u00a0weeks\u2019 dose titration and 32\u00a0weeks\u2019 fixed\u2010dose treatment.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Measurements<\/jats:title>\n                    <jats:p>Primary endpoint was the incidence of adverse events (AEs). Secondary endpoints included change from baseline to week\u00a052 in visceral, subcutaneous and total adipose tissue (VAT, SAT and TAT).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Mean (SD) prescribed doses after titration were 1.780 (1.058)\u00a0mg\/week for somapacitan and 0.197 (0.083)\u00a0mg\/day for daily GH. Rate of AEs per 100\u00a0patient\u2010years was similar between arms (somapacitan, 312.7; daily GH, 309.8). Four AEs in the somapacitan arm were serious; none were considered treatment\u2010related. Mean insulin\u2010like growth factor\u2010I standard deviation score (IGF\u2010I SDS) was maintained from baseline in both arms. No significant differences were observed between arms for change from baseline to week\u00a052 in VAT, SAT or TAT (estimated difference, somapacitan \u2013 daily GH [95%\u00a0CI]: \u22121.74 [\u221218.13;\u00a014.66], \u221211.53 [\u221235.54;\u00a012.48] and\u00a0\u2212\u00a012.85 [\u221247.31;\u00a021.62] cm\n                      <jats:sup>2<\/jats:sup>\n                      , respectively).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>\n                      Treatment in both groups was well tolerated, with no unexpected safety findings. Impact on adipose tissue was similar to somapacitan and daily GH in patients with AGHD. A short visual summary of our work is available at\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/bit.ly\/3946YNF\">https:\/\/bit.ly\/3946YNF<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/cen.14273","type":"journal-article","created":{"date-parts":[[2020,6,30]],"date-time":"2020-06-30T17:39:08Z","timestamp":1593538748000},"page":"620-628","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":39,"title":["Similar safety and efficacy in previously treated adults with growth hormone deficiency randomized to once\u2010weekly somapacitan or daily growth hormone"],"prefix":"10.1111","volume":"93","author":[{"given":"Fumio","family":"Otsuka","sequence":"first","affiliation":[{"name":"Department of General Medicine Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Okayama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yutaka","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Division of Diabetes and Endocrinology Department of Internal Medicine Kobe University Graduate School of Medicine Kobe Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shigeyuki","family":"Tahara","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery Nippon Medical School Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshihisa","family":"Ogawa","sequence":"additional","affiliation":[{"name":"CMR Development Division Novo Nordisk Pharma Ltd. Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2210-0366","authenticated-orcid":false,"given":"Michael","family":"H\u00f8jby Rasmussen","sequence":"additional","affiliation":[{"name":"Global Development Novo Nordisk A\/S S\u00f8borg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Koji","family":"Takano","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, Diabetes and Metabolism Kitasato University Sagamihara Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2020,8,14]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1817346"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2005-2227"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2007-2810"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2015-1006"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.4158\/EP.14.2.143"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/cen.13030"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1530\/EJE-16-0111"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2015-1991"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2014-1702"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1111\/cen.13409"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1530\/EJE-17-1073"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1210\/clinem\/dgaa049"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1210\/clinem\/dgz310"},{"key":"e_1_2_10_15_1","unstructured":"OtsukaF TakahashiY TaharaSet al.Animated summary.https:\/\/bit.ly\/3946YNF"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2013.281053"},{"key":"e_1_2_10_17_1","volume-title":"ICH Harmonised Tripartite Guideline for Good Clinical Practice","author":"International Conference on Harmonisation","year":"1996"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1210\/jc.2013-3059"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1186\/1477-7525-2-12"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40262-018-0662-5"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1530\/EJE-17-1073"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1530\/EJE-18-0306"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1152\/ajpendo.00129.2018"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1080\/17446651.2019.1689119"}],"container-title":["Clinical Endocrinology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fcen.14273","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cen.14273","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/cen.14273","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/cen.14273","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,1]],"date-time":"2023-09-01T13:07:31Z","timestamp":1693573651000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/cen.14273"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2020,8,14]]},"references-count":23,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2020,11]]}},"alternative-id":["10.1111\/cen.14273"],"URL":"https:\/\/doi.org\/10.1111\/cen.14273","archive":["Portico"],"relation":{},"ISSN":["0300-0664","1365-2265"],"issn-type":[{"value":"0300-0664","type":"print"},{"value":"1365-2265","type":"electronic"}],"subject":[],"published":{"date-parts":[[2020,8,14]]},"assertion":[{"value":"2020-05-20","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-06-24","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2020-08-14","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}