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

Korábbi kezelés

• Other weight loss treatments within 90 days before screening
• Previous surgical treatment for obesity
• Known or suspected abuse of alcohol or recreational drugs

Más betegség

• Other chronic diseases
• History of pancreatitis (acute or chronic, regardless of the number of years)
• Severe psychiatric disorder (e.g., schizophrenia, bipolar disorder)
• A lifetime history of suicidal attempt
• History of NEM2 or medullary thyroid carcinoma, malignant neoplasms/carcinomas in situ, or uncontrolled thyroid disease
• 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
• History of type 1 or type 2 diabetes
• Patient with hepatic impairment (mild to severe)

Laborértékek

• Patient with severe renal insufficiency (eGFR < 30 mL/min/1,73m2)

Egyéb

• Mental retardation
• Inability to understand the study
• Major problem of compliance with existing treatments (suggesting that compliance with the protocol will be insufficient)
• 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

• 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