Peer-reviewed article
Semaglutide as adjunct treatment for obesity in adolescents receiving antipsychotic medication (the GOAL trial): protocol for a single-arm, open-label feasibility study.
Giraldi LV, Andersen JT, Jespersen J, Baden CS, Fonvig CE et al. ·
Summary
Written by AI, not yet AICS's view · claude-haiku-4-5-20251001This is a protocol for a feasibility study testing whether semaglutide (a weight-loss medication) can safely help adolescents aged 12-18 who have become obese as a side effect of antipsychotic medications. The study will involve 34 adolescents in Denmark receiving the medication weekly for 36 weeks alongside their normal psychiatric care. The main goal is to determine whether the treatment is feasible to deliver and whether adolescents can complete the full course, with secondary measures of weight loss and metabolic health.
Key points
- Adolescents on antipsychotic medication have increased risk of obesity and metabolic complications with limited evidence-based interventions available
- The study enrolls 34 adolescents aged 12-18 years with obesity (BMI SD score ≥+1.28 and body fat ≥95th percentile) on stable antipsychotic treatment
- Participants receive once-weekly subcutaneous semaglutide up to 2.4 mg for 36 weeks plus standard care, followed by 18-month observational follow-up
- Primary outcome is study completion rate; secondary outcomes include changes in BMI, body composition, metabolic biomarkers and psychiatric outcomes
- This feasibility study is designed to inform the design of a subsequent randomised controlled trial
Limitations
This is a protocol document, not a results paper, so it describes a study that has not yet been completed and provides no empirical findings about effectiveness. As a single-arm, open-label feasibility study with no comparison group, it cannot establish whether semaglutide actually works better than placebo or standard care alone.
Abstract
Introduction 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. Methods and analysis 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 12-18 years with obesity, defined as body mass index SD score equal to or greater than +1.28 and 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. Ethics and dissemination 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 17 471-21-02). Written informed consent will be obtained from participants and their legal guardians. Results will be disseminated through peer-reviewed publications and scientific conferences. Trial registration number 2024-5 17 471-21-02.
Findings the Hub has extracted
Each claim below is labelled by its type of design and links back to this report.
- Intervention
- Once-weekly subcutaneous semaglutide (glucagon-like peptide-1 receptor agonist) at dose up to 2.4 mg for 36 weeks as adjunct to standard care
- Population
- 34 adolescents aged 12-18 years with obesity (BMI SD score ≥+1.28 and body fat ≥95th percentile) receiving stable antipsychotic treatment for psychiatric diagnoses (psychotic disorders, mood disorders, neurodevelopmental disorders)
Key finding
This is a protocol study; no outcomes have been measured yet
LV et al. · Europe PMC · 17 Sept 2026