SEMAGLUTIDE for Obesity|Antipsychotic-related obesity

Inclusion criteria

• {"criterion_text":"- Age ≥12 and ≤18 years\n- BMI SDS ≥ 1.28 which corresponds to BMI ≥ 90 percentile according to Danish Growth Charts\n- Body composition of Body Fat Percentage ≥ 95 percentile as confirmed by Bioelectrical Impedance Analysis (BIA)\n- Minimum of four weeks of stable condition under ongoing antipsychotic treatment. Flexible dose adjustment during the trial according to clinical need is allowed\n- Verbal informed consent and assent from trial participants and oral and written informed consent from the custody holder/s and trial participants ≥ 15 years of age\n- Verbal informed consent from female participants to use contraceptive methods throughout the trial"}

Exclusion criteria

• {"criterion_text":"- GLP-1-RA treatment within 35 days before baselinea\n- Any condition that the investigator judge would interfere with trial participation.\n- Previously known allergic reactions to active ingredients in Wegovy.\n- Inability to communicate in Danish.\n- Compulsory treatment (i.e., use of coercive measures)\n- Pregnancy\n- Known acute or chronic liver disease\n- Known acute or chronic kidney disease\n- Known acute or chronic pancreatic disease\n- Known type 1 diabetes and/or treatment with insulin.\n- Treatment with systemic corticosteroids or other hormone therapy (except from contraception)"}

Primary endpoints

• {"endpoint_text":"- Number of subjects completing the study from baseline to end-of-treatment","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Body composition and bone mineral density evaluated by DXA.","definition_or_measurement_approach":"Evaluated by DXA (dual-energy X-ray absorptiometry)."}
• {"endpoint_text":"- Blood pressure and heart rate.","definition_or_measurement_approach":"Clinical measurement of blood pressure and heart rate."}
• {"endpoint_text":"- Changes in total body weight, hip and waist circumference.","definition_or_measurement_approach":"Anthropometric measurements (weight, hip and waist circumference)."}
• {"endpoint_text":"- Beta cell function evaluated by homeostatic model assessment (HOMA).","definition_or_measurement_approach":"Assessed using HOMA from blood glucose and insulin measurements."}
• {"endpoint_text":"- Measures of psychopathology: Clinical Global Impressions Scale severity scale (CGI-S).","definition_or_measurement_approach":"Psychopathology assessed using CGI-S."}
• {"endpoint_text":"- Antipsychotic medications, diet and exercise recorded in a diary together with alcohol, tobacco, recreational drug, and medication use.","definition_or_measurement_approach":"Participant diary recording antipsychotic medication, diet, exercise, alcohol, tobacco, recreational drug and other medication use."}
• {"endpoint_text":"- Change in blood sampling markers of Hepato-biliary biomarkers, Metabolic biomarkers, Inflammatory biomarkers, Lipid profile.","definition_or_measurement_approach":"Laboratory blood assays for hepato-biliary, metabolic, inflammatory markers and lipid profile."}
• {"endpoint_text":"- 6-month follow-up assessing continuation of GLP-1-RA use on participant’s own initiative.","definition_or_measurement_approach":"6-month follow-up assessment of continuation of GLP-1-RA use (participant report/medical record)."}
• {"endpoint_text":"- MASLD evaluated by MRI proton density fat-fraction and biochemistry.","definition_or_measurement_approach":"MASLD assessed by MRI proton density fat-fraction and biochemical tests."}
• {"endpoint_text":"- Change in fat percentages using bioelectrical impedance analysis","definition_or_measurement_approach":"Body fat percentage measured by bioelectrical impedance analysis (BIA)."}
• {"endpoint_text":"- Body-mass index standard deviation score (BMI-SDS)","definition_or_measurement_approach":"BMI-SDS calculated from measured height and weight against reference charts."}

Denmark

Earliest CTIS Part Ii Submission Date

28-04-2025

Latest Decision Or Authorization Date

27-02-2026

Processing Time Days

305

Number Of Sites

1

Number Of Participants

34

Primary sponsor

Full Name

Clinical Pharmacology, Department of

Organisation Type

Health care

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"GCP-enheden ved Københavns Universitetshospital","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Health care"}