Semaglutide as adjunct treatment for obesity in adolescents receiving antipsychotic medication (the GOAL trial): protocol for a single-arm, open-label feasibility study

What Was Tested

This clinical study looks at Semaglutide.

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.

Why It Was Studied

The findings from this feasibility trial will inform the design and support the scale-up of a subsequent randomised controlled trial.

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).

Who Took Part

According to the abstract, 34 adolescents were involved.

The age groups tagged for this paper are children and teenagers, both men and women.

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.

How the Study Was Run

In design terms this was a randomized and open-label study.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Being open-label, the Semaglutide study did not mask who received what.

Adolescents receiving antipsychotic treatment under coercion are excluded.

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.

What Was Measured

Topics PubMed links to this paper include Antipsychotic Agents, Body Mass Index, Denmark, Feasibility Studies, Glucagon-Like Peptide-1 Receptor Agonists, Mental Disorders and Pediatric Obesity.

Author keywords: Adolescent, Child & adolescent psychiatry, Clinical Protocols and Clinical Trial.

What This Means in Plain Language

The paper is a randomized and open-label study of Semaglutide in 34 adolescents.

With fewer than 40 people, it is a small study, so it is better read as an early signal for further research than as a settled answer.

The publication is from 2026 (BMJ open), a journal based in England.

More context: the Semaglutide compound page, all human trials.