SEMAFORCRANIO : Multicenter, Double-blind, Parallel, Randomized Controlled Trial of the Efficacy of Semaglutide in Hypothalamic Obesity Secondary to Craniopharyngioma in Children Aged 12 to 17 Years

Who can take part

Inclusion Criteria: * Age 12 to 17 years Treated craniopharyngioma whose last intervention was \>6 months ago and whose tumor is considered stable with : * surgical treatmentsurgery for the solid area (non-cystic portion) of the tumor was \>6 months ago and whose tumor is considered stable * irradiation treatment * Appropriate pituitary replacements (including recombinant growth hormone replacement in case of growth hormone deficiency), as assessed by the attending child's physician, according to international recommendations. * BMI \> + 2 SD of the French references (overweight and obesity) or BMI gain ≥ + 1 SD over the past 6 to 12 months (in the absence of overweight or obesity) * Failure to control weight despite strict adherence to dietary guidelines for at least six months (healthy nutrition and physical activity counseling provided by a dietician or other qualified healthcare professional) * For women patients with spontaneous menarche (without the use of hormone treatment with oestrogens), highly effective contraceptive methods during all study participation (and until 7 weeks after last study drug intake) * Subjects covered by or having the rights to medical care assurance * Written consent signed by the parents or legally acceptable representatives of the subject, and child participation agreement Exclusion Criteria: * Other weight loss treatments within 90 days before screening * Previous surgical treatment for obesity * Other chronic diseases * History of pancreatitis (acute or chronic, regardless of the number of years) * Severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) * Mental retardation * A lifetime history of suicidal attempt * History of NEM2 or medullary thyroid carcinoma, malignant neoplasms/carcinomas in situ, or uncontrolled thyroid disease * Inability to understand the study * Major problem of compliance with existing treatments (suggesting that compliance with the protocol will be insufficient) * Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria which, in the investigator's opinion, might jeopardize the participant's safety or compliance with the protocol * Known or suspected abuse of alcohol or recreational drugs * History of type 1 or type 2 diabetes * Patient with severe renal insufficiency (eGFR \< 30 mL/min/1,73m2) * Patient with hepatic impairment (mild to severe) * Participation in another interventional research modifying management or likely to influence the study's assessment criteria * Pregnancy or desire of pregnancy, breast-feeding patients and parturients

Registry changes

No changes recorded since the trial was added.