Young Adults With Early-onset Obesity Treated With Semaglutide
ObesityAdolescentIntroduction: The increasing prevalence of obesity is particularly pronounced among adolescents. Currently available treatment options consist 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. 130-170 young adults (age 18-28) will be recruited from The Children's Obesity Clinic (TCOC), Department of Pediatrics, Holbæk Hospital. Based on their previous response to the TCOC protocol the participants will be divided 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.
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