Semaglutide for Weight Gain After Craniopharyngioma Brain Tumor in Teenagers

Trial details

Who runs it

University Hospital, Angers

Trial code

NCT07845994EU 2024-511114-20-00

Record updated

29 September 2026

Original description

Craniopharyngioma (CP) is a rare embryonic brain tumor of the sellar and parasellar region. Despite its benign histologic characteristics, it is locally aggressive and may cause severe morbidity from invasion into adjacent tissues and structures. Hypothalamic damage due to the tumor or its management is responsible for rapid and massive obesity, one of the most severe sequelae in patients with craniopharyngioma. Current treatment of craniopharyngioma is neurosurgical, possibly completed by radiotherapy. For preventing hypothalamic damage, surgery is the most "sparing" possible for the hypothalamus, possibly completed by a highly conformation radiation treatment, such as proton beam therapy.Read full original descriptionShow less

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

Craniopharyngioma (CP) is a rare embryonic brain tumor of the sellar and parasellar region. Despite its benign histologic characteristics, it is locally aggressive and may cause severe morbidity from invasion into adjacent tissues and structures. Hypothalamic damage due to the tumor or its management is responsible for rapid and massive obesity, one of the most severe sequelae in patients with craniopharyngioma. Current treatment of craniopharyngioma is neurosurgical, possibly completed by radiotherapy. For preventing hypothalamic damage, surgery is the most "sparing" possible for the hypothalamus, possibly completed by a highly conformation radiation treatment, such as proton beam therapy.

Despite these therapeutic advances, obesity remains a significant problem in 30 to 50% of cases today. Most studies showed that the mean BMI at diagnosis of childhood craniopharyngioma was 0.5-0.8 ± 1.5 SD score, the mean BMI gain was +2 to +3 ± 2 SD score within 3 years, with a relative stabilization or a slow increase after 3 years. When there is an anterior and posterior hypothalamic involvement (about 50% of the cases), the mean BMI gain is even higher (+4 ± 3 SD score within 3 years).

Semaglutide, a GLP1RA in weekly injection, has shown its great effectiveness for losing weight in obese adults and adolescents (mean difference in BMI change - 16.7% with semaglutide vs. placebo after 68 weeks). Preliminary data in obese children with craniopharyngioma have shown a mean 25% difference in annual BMI gain (with semaglutide treatment compared to the previous year with no semaglutide in the same children).

Inclusion: 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: Other weight loss treatments within 90 days before screening; Previous surgical treatment for obesity; Known or suspected abuse of alcohol or recreational drugs; 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); Patient with severe renal insufficiency (eGFR < 30 mL/min/1,73m2); 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.

ClinicalTrials.gov NCT07845994 · EU CTIS 2024-511114-20-00