Young Adults With Early-onset Obesity Treated With Semaglutide
Status:
Recruiting
Trial end date:
2026-06-01
Target enrollment:
Participant gender:
Summary
Introduction: Obesity prevalence is particularly pronounced among adolescents. Currently
available treatment options consists of structured lifestyle interventions. However, 25 % of
adolescents do not respond to lifestyle treatment, why new effective treatment strategies are
needed. Therefore, the aim of this study is to investigate the effect of lifestyle
interventions combined with the GLP-1 receptor agonist semaglutide to young adults with
otherwise treatment resistant obesity.
Methods and analysis: This is an investigator-initiated, randomized, placebo-controlled
trial. We will recruit 130-170 young adults (age 18-28) from The Children's Obesity Clinic
(TCOC), Department of Pediatrics, Holbæk Hospital. Based on their previous response to the
TCOC protocol we will divide them in three groups:
Group A: Non-responders: 55-75 young adults (BMI>30 kg/m2) who have not succeeded in losing
weight during the structured lifestyle intervention (BMI SDS reduction <0.1) Group B:
Insufficient responders: 55-75 young adults (BMI>30 kg/m2) who have succeeded in losing
weight during the structured lifestyle intervention (BMI SDS reduction >0.25), but still have
obesity.
Group C: Excellent responders: 20 young adults, who have succeeded in losing weight during
the structured lifestyle intervention (BMI SDS reduction >0.5) and no longer have obesity
(BMI<30 kg/m2).
Group A and B are randomized 2:1 to either semaglutide or placebo for 68 weeks. Group C will
attend baseline examinations only and not undergo intervention. The primary endpoint is
change in BMI from randomization to end-of-treatment.
Ethics and dissemination: The trial has been approved by the Danish Medicines Agency (EudraCT
2019-002274-31) and by the ethical committee of the Capital Region of Denmark (H-20039422).
The trial will be conducted in agreement with the Declaration of Helsinki and monitored to
follow the guidelines for good clinical practice. Results will be submitted for publication
in international peer-reviewed scientific journals.
Phase:
Phase 4
Details
Lead Sponsor:
Signe Torekov
Collaborators:
Holbaek Sygehus Karolinska Institutet Rigshospitalet, Denmark University of Leeds