The GOAL study: GLP-1 receptor agonist treatment for Adolescents with Obesity secondary to Antipsychotic Medication - A feasibility study

Conditions

Adipositas

Brief summary

Change in the body-mass index standard-deviation score (BMI-SDS) from baseline to week 32.

Detailed description

Body composition and bone mineral density evaluated by DXA., Blood pressure and heart rate., Changes in total body weight, hip and waist circumference., Beta cell function evaluated by homeostatic model assessment (HOMA)., Measures of psychopathology: Clinical Global Impressions Scale severity scale (CGI-S)., Antipsychotic medications, diet and exercise recorded in a diary together with alcohol, tobacco, recreational drug, and medication use., Change in blood sampling markers of Hepato-biliary biomarkers, Metabolic biomarkers, Inflammatory biomarkers, Lipid profile., 6-month follow-up assessing continuation of GLP-1-RA use on participant’s own initiative., MASLD evaluated by MRI proton density fat-fraction and biochemistry., Change in fat percentages using bioelectrical impedance analysis

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Interventions

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DRUGWegovy 0.5 mg FlexTouch solution for injection in pre-filled pen

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Change in the body-mass index standard-deviation score (BMI-SDS) from baseline to week 32.	—

Secondary

Measure	Time frame
Body composition and bone mineral density evaluated by DXA., Blood pressure and heart rate., Changes in total body weight, hip and waist circumference., Beta cell function evaluated by homeostatic model assessment (HOMA)., Measures of psychopathology: Clinical Global Impressions Scale severity scale (CGI-S)., Antipsychotic medications, diet and exercise recorded in a diary together with alcohol, tobacco, recreational drug, and medication use., Change in blood sampling markers of Hepato-biliary biomarkers, Metabolic biomarkers, Inflammatory biomarkers, Lipid profile., 6-month follow-up assessing continuation of GLP-1-RA use on participant’s own initiative., MASLD evaluated by MRI proton density fat-fraction and biochemistry., Change in fat percentages using bioelectrical impedance analysis	—

Measure

Time frame

Body composition and bone mineral density evaluated by DXA., Blood pressure and heart rate., Changes in total body weight, hip and waist circumference., Beta cell function evaluated by homeostatic model assessment (HOMA)., Measures of psychopathology: Clinical Global Impressions Scale severity scale (CGI-S)., Antipsychotic medications, diet and exercise recorded in a diary together with alcohol, tobacco, recreational drug, and medication use., Change in blood sampling markers of Hepato-biliary biomarkers, Metabolic biomarkers, Inflammatory biomarkers, Lipid profile., 6-month follow-up assessing continuation of GLP-1-RA use on participant’s own initiative., MASLD evaluated by MRI proton density fat-fraction and biochemistry., Change in fat percentages using bioelectrical impedance analysis

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Countries

Denmark

Outcome results

None listed