{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T12:04:40Z","timestamp":1789646680854,"version":"4.0.0"},"reference-count":27,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T00:00:00Z","timestamp":1789603200000},"content-version":"unspecified","delay-in-days":16,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,8,26]]},"published-print":{"date-parts":[[2026,9]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>Adolescents treated with antipsychotic medication are at increased risk of obesity and metabolic complications, yet evidence-based interventions in this group remain limited. Glucagon-like peptide-1 receptor agonists have demonstrated efficacy in the treatment of obesity in both adults and adolescents. The aim of this trial is to assess the feasibility of a 36-week treatment period with a glucagon-like peptide-1 receptor agonist as an adjunct to standard care in adolescents with antipsychotic-associated obesity, defined as completion from baseline to end of treatment. The findings from this feasibility trial will inform the design and support the scale-up of a subsequent randomised controlled trial.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>The GOAL trial is a single-arm, open-label feasibility study conducted at Copenhagen University Hospital, Bispebjerg, Denmark, in collaboration with the Child and Adolescent Mental Health Center. A total of 34 adolescents aged 12\u201318 years with obesity, defined as body mass index SD score equal to or greater than +1.28\u2009and body fat percentage at or above the 95th percentile, receiving stable antipsychotic treatment will be enrolled. The study population includes adolescents with a range of psychiatric diagnoses requiring antipsychotic treatment, including psychotic disorders, mood disorders and neurodevelopmental disorders. Adolescents receiving antipsychotic treatment under coercion are excluded. Participants will receive once-weekly subcutaneous semaglutide at a dose up to 2.4 milligrams for 36 weeks in addition to standard care, followed by an 18-month observational follow-up period. The primary outcome is study completion rate. Additional feasibility outcomes include recruitment rate, treatment adherence and completion of study procedures. Secondary outcomes include changes in body mass index SD score, body composition, metabolic biomarkers and psychiatric outcomes. Feasibility outcomes will be analysed descriptively. Exploratory longitudinal analyses will be conducted using linear mixed-effects models.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The study complies with the Declaration of Helsinki and European Union Clinical Trials Regulation (536\/2014) and is approved in the Clinical Trials Information System (2024-5\u200917\u2009471-21-02). Written informed consent will be obtained from participants and their legal guardians. Results will be disseminated through peer-reviewed publications and scientific conferences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>2024-5\u200917\u2009471-21-02.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2026-123779","type":"journal-article","created":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T11:45:35Z","timestamp":1789645535000},"page":"e123779","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Semaglutide as adjunct treatment for obesity in adolescents receiving antipsychotic medication (the GOAL trial): protocol for a single-arm, open-label feasibility study"],"prefix":"10.1136","volume":"16","author":[{"given":"Laura Victoria","family":"Giraldi","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jon Tr\u00e6rup","family":"Andersen","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark"},{"name":"Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonas","family":"Jespersen","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christoffer Storm","family":"Baden","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cilius Esmann","family":"Fonvig","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"},{"name":"Department of Pediatrics, Copenhagen University Hospital, Holbaek, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Troels","family":"Riis","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kim Peder","family":"Dalhoff","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark"},{"name":"Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jens-Christian","family":"Holm","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"},{"name":"Department of Pediatrics, Copenhagen University Hospital, Holbaek, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anders","family":"Fink-Jensen","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"},{"name":"Psychiatric Center Copenhagen, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anne Katrine","family":"Pagsberg","sequence":"additional","affiliation":[{"name":"Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"},{"name":"Child- and adolescent mental health center Research Unit, Gentofte, Capital Region Mental Health Services, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mikkel Bring","family":"Christensen","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark"},{"name":"Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0007-6158","authenticated-orcid":false,"given":"Christina","family":"Gade","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology, Bispebjerg-Frederiksberg Hospital, Copenhagen, Denmark"},{"name":"Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,9,17]]},"reference":[{"key":"2026091704451999000_16.9.e123779.1","unstructured":"WHO . WHO | childhood overweight and obesity. Available: http:\/\/www.who.int\/dietphysicalactivity\/childhood\/en\/ [Accessed 18 Jun 2014]."},{"key":"2026091704451999000_16.9.e123779.2","doi-asserted-by":"crossref","first-page":"285","DOI":"10.3390\/children10020285","article-title":"Psychiatric Disorders and Obesity in Childhood and Adolescence\u2014A Systematic Review of Cross-Sectional Studies","volume":"10","author":"Kokka","year":"2023","journal-title":"Children"},{"key":"2026091704451999000_16.9.e123779.3","doi-asserted-by":"crossref","first-page":"41","DOI":"10.1111\/j.1758-8111.2012.00038.x","article-title":"Liver fat content investigated by magnetic resonance spectroscopy in obese children and youths included in multidisciplinary treatment","volume":"2","author":"Bille","year":"2012","journal-title":"Clin Obes"},{"key":"2026091704451999000_16.9.e123779.4","doi-asserted-by":"publisher","DOI":"10.1016\/j.euroneuro.2010.07.002"},{"key":"2026091704451999000_16.9.e123779.5","article-title":"Antipsychotic switching for people with schizophrenia who have neuroleptic-induced weight or metabolic problems","volume":"2010","author":"Mukundan","year":"2010","journal-title":"Cochrane Database Syst Rev"},{"key":"2026091704451999000_16.9.e123779.6","doi-asserted-by":"crossref","first-page":"1065","DOI":"10.1001\/jamapsychiatry.2025.2332","article-title":"Semaglutide Treatment of Antipsychotic-Treated Patients With Schizophrenia, Prediabetes, and Obesity: The HISTORI Randomized Clinical Trial","volume":"82","author":"Ganeshalingam","year":"2025","journal-title":"JAMA Psychiatry"},{"key":"2026091704451999000_16.9.e123779.7","doi-asserted-by":"crossref","DOI":"10.3390\/cells8111336","article-title":"Second-Generation Antipsychotics and Dysregulation of Glucose Metabolism: Beyond Weight Gain","volume":"8","author":"Grajales","year":"2019","journal-title":"Cells"},{"key":"2026091704451999000_16.9.e123779.8","doi-asserted-by":"crossref","first-page":"103","DOI":"10.1002\/wps.21279","article-title":"Excess cardiometabolic risk in children and adolescents initiating antipsychotic treatment compared to young adults: results from a nationwide cohort study","volume":"24","author":"H\u00f8jlund","year":"2025","journal-title":"World Psychiatry"},{"key":"2026091704451999000_16.9.e123779.9","doi-asserted-by":"publisher","DOI":"10.1111\/dom.13522"},{"key":"2026091704451999000_16.9.e123779.10","doi-asserted-by":"publisher","DOI":"10.1111\/dom.14280"},{"key":"2026091704451999000_16.9.e123779.11","doi-asserted-by":"crossref","first-page":"3","DOI":"10.1111\/acps.13769","article-title":"How to treat antipsychotic-related weight gain and metabolic disturbances: Is there a role for GLP-1 receptor agonists?","volume":"151","author":"Fink-Jensen","year":"2025","journal-title":"Acta Psychiatr Scand"},{"key":"2026091704451999000_16.9.e123779.12","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2208601"},{"key":"2026091704451999000_16.9.e123779.13","doi-asserted-by":"crossref","first-page":"209","DOI":"10.1038\/s41366-023-01400-7","article-title":"A new approach to quantify visceral fat via bioelectrical impedance analysis and ultrasound compared to MRI","volume":"48","author":"Hoffmann","year":"2024","journal-title":"Int J Obes"},{"key":"2026091704451999000_16.9.e123779.14","first-page":"28","article-title":"The clinical global impressions scale: applying a research tool in clinical practice","volume":"4","author":"Busner","year":"2007","journal-title":"Psychiatry Edgmont Pa Townsh"},{"key":"2026091704451999000_16.9.e123779.15","unstructured":"REDCap. Available: https:\/\/project-redcap.org\/ [Accessed 9 Oct 2025]."},{"key":"2026091704451999000_16.9.e123779.16","unstructured":"R: the R project for statistical computing. Available: https:\/\/www.r-project.org\/ [Accessed 10 Oct 2025]."},{"key":"2026091704451999000_16.9.e123779.17","unstructured":"Smith R . Regulation (EU) No 492\/2011 of the European Parliament and of the Council of 5 April 2011. Core EU Legislation. London: Macmillan Education UK, 2011."},{"key":"2026091704451999000_16.9.e123779.18","unstructured":"Clinical trials information system | European medicines agency (EMA). 2022. Available: https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/research-development\/clinical-trials-human-medicines\/clinical-trials-information-system [Accessed 9 Oct 2025]."},{"key":"2026091704451999000_16.9.e123779.19","unstructured":"Indenrigs- og Sundhedsministeriet . Bekendtg\u00f8relse om kliniske fors\u00f8g med l\u00e6gemidler. 2022."},{"key":"2026091704451999000_16.9.e123779.20","unstructured":"EMA . Wegovy-epar-product-information_da.pdf. 2022. Available: https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/wegovy-epar-product-information_da.pdf [Accessed 24 May 2022]."},{"key":"2026091704451999000_16.9.e123779.21","doi-asserted-by":"crossref","DOI":"10.3389\/fphar.2024.1364110","article-title":"Pancreatitis with use of new diabetic medications: a real-world data study using the post-marketing FDA adverse event reporting system (FAERS) database","volume":"15","author":"Alenzi","year":"2024","journal-title":"Front Pharmacol"},{"key":"2026091704451999000_16.9.e123779.22","doi-asserted-by":"crossref","first-page":"1071","DOI":"10.1016\/j.survophthal.2023.07.002","article-title":"GLP-1 receptor agonists and diabetic retinopathy: A meta-analysis of randomized clinical trials","volume":"68","author":"Kapoor","year":"2023","journal-title":"Surv Ophthalmol"},{"key":"2026091704451999000_16.9.e123779.23","doi-asserted-by":"crossref","first-page":"16","DOI":"10.1111\/dom.15728","article-title":"Changes in lean body mass with glucagon-like peptide-1-based therapies and mitigation strategies","volume":"26 Suppl 4","author":"Neeland","year":"2024","journal-title":"Diabetes Obes Metab"},{"key":"2026091704451999000_16.9.e123779.24","doi-asserted-by":"crossref","first-page":"497","DOI":"10.1517\/17425255.2014.885502","article-title":"Methods for pharmacokinetic analysis in young children","volume":"10","author":"Himebauch","year":"2014","journal-title":"Expert Opin Drug Metab Toxicol"},{"key":"2026091704451999000_16.9.e123779.25","unstructured":"Danish-data-protection-act.pdf."},{"key":"2026091704451999000_16.9.e123779.26","unstructured":"General data protection regulation (GDPR) \u2013 legal text. Gen Data Prot Regul GDPR. Available: https:\/\/gdpr-info.eu\/ [Accessed 9 Oct 2025]."},{"key":"2026091704451999000_16.9.e123779.27","unstructured":"ICMJE | recommendations | defining the role of authors and contributors. Available: https:\/\/www.icmje.org\/recommendations\/browse\/roles-and-responsibilities\/defining-the-role-of-authors-and-contributors.html [Accessed 9 Oct 2025]."}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2026-123779","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T11:45:46Z","timestamp":1789645546000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2026-123779"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,9]]},"references-count":27,"journal-issue":{"issue":"9","published-online":{"date-parts":[[2026,9,17]]},"published-print":{"date-parts":[[2026,9]]}},"alternative-id":["10.1136\/bmjopen-2026-123779"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2026-123779","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,9]]}}}