{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,27]],"date-time":"2026-08-27T11:05:36Z","timestamp":1787828736604,"version":"build-2784847793"},"reference-count":40,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2026,3,30]],"date-time":"2026-03-30T00:00:00Z","timestamp":1774828800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2026,3,30]],"date-time":"2026-03-30T00:00:00Z","timestamp":1774828800000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100000062","name":"National Institute of Diabetes and Digestive and Kidney Diseases","doi-asserted-by":"publisher","award":["K23DK125668"],"award-info":[{"award-number":["K23DK125668"]}],"id":[{"id":"10.13039\/100000062","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["dom-pubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Diabetes Obesity Metabolism"],"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aims<\/jats:title>\n                    <jats:p>Treatment options for adolescents with obesity are limited, and some may benefit from lower maintenance doses of semaglutide. This study used model\u2010informed drug development (MIDD) to evaluate whether a 1.7\u2010mg maintenance dose provides comparable exposure, tolerability and BMI effects in adolescents versus adults and versus the 2.4\u2010mg dose.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Materials and Methods<\/jats:title>\n                    <jats:p>\n                      Simulation analyses combined pharmacokinetic, BMI and safety data from the adolescent STEP TEENS Phase 3 study (\n                      <jats:italic>N<\/jats:italic>\n                      \u2009=\u2009201) and the adult semaglutide STEP studies (Phases 2\u20133; ~3100 participants). Data across doses (0.25\u20132.4\u2009mg) were used to model concentration\u2013time profiles, extrapolate percent change in BMI for 1.7\u2009mg, estimate proportions achieving \u2265\u20095%, \u2265\u200910% and \u2265\u200915% BMI reductions and predict gastrointestinal adverse event (AE) incidence as a function of exposure.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Modelled semaglutide concentrations over 68\u2009weeks were similar between adolescents and adults; body weight was the main covariate influencing exposure. For adolescents, the 1.7\u2010mg dose showed comparable efficacy to 2.4\u2009mg (mean BMI change: \u221215.2% vs. \u221217.4%) and was significantly greater than placebo (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.01). Predicted proportions achieving prespecified BMI reduction thresholds and gastrointestinal AE profiles were similar across populations and doses.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>PK\/PD and safety modelling indicated 1.7\u2009mg semaglutide provides comparable exposure, tolerability and meaningful BMI reduction in adolescents versus adults and versus 2.4\u2009mg. These results supported approval of 1.7\u2009mg for adolescents \u2265\u200912\u2009years in the November 2024 Wegovy label, obviating a dedicated adolescent 1.7\u2010mg placebo trial.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/dom.70678","type":"journal-article","created":{"date-parts":[[2026,3,30]],"date-time":"2026-03-30T08:50:22Z","timestamp":1774860622000},"page":"4926-4934","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Efficacy, Safety and Pharmacokinetics of Semaglutide 1.7\u2009mg for Obesity Treatment in Adolescents: A Model\u2010Informed Drug Development Approach"],"prefix":"10.1111","volume":"28","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1598-2591","authenticated-orcid":false,"given":"Anders","family":"Strathe","sequence":"first","affiliation":[{"name":"Novo Nordisk A\/S  S\u00f8borg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8037-4314","authenticated-orcid":false,"given":"Eric M.","family":"Bomberg","sequence":"additional","affiliation":[{"name":"Center for Pediatric Obesity Medicine and Division of Endocrinology, Department of Pediatrics University of Minnesota Medical School  Minneapolis Minnesota USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Garrit","family":"Jensch","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S  S\u00f8borg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonas","family":"Kildegaard","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S  S\u00f8borg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nina M.","family":"Harder\u2010Lauridsen","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S  S\u00f8borg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Weghuber","sequence":"additional","affiliation":[{"name":"Paracelsus Medical University Department of Pediatrics  Salzburg Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7095-4270","authenticated-orcid":false,"given":"Rune Viig","family":"Overgaard","sequence":"additional","affiliation":[{"name":"Novo Nordisk A\/S  S\u00f8borg Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,3,30]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pop.2015.10.001"},{"key":"e_1_2_12_3_1","volume-title":"World Obesity Atlas 2025","author":"World Obesity Federation","year":"2025"},{"key":"e_1_2_12_4_1","article-title":"Clinical Practice Guideline for the Evaluation and Treatment of Children and Adolescents With Obesity","volume":"151","author":"Hampl S. 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