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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
Sponsor: University Hospital, Angers
Summary
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).
Key Details
Gender
All
Age Range
12 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2026-11
Completion Date
2031-02
Last Updated
2026-09-29
Healthy Volunteers
No
Conditions
Interventions
Semaglutide (Wegovy) weekly injection
A 40-week randomized, controlled, double-blind semaglutide (versus placebo) intervention (versus placebo), followed by an open phase from weeks 40 to 80 where all participants receive semaglutide. In first 40 weeks period (0-40 weeks), Semaglutide is initiated at a dose of 0.25 mg once weekly for the first 4 weeks, followed by escalation every 4 weeks to 0.50, 1.0, 1.70, and 2.40 mg. In second 40 weeks period (40-80 weeks), Semaglutide is maintened at maximum tolerated dose form 1st period. The recommended target maintenance dose of semaglutide or placebo is 2.4 mg once weekly. Participants are encouraged to reach the recommended semaglutide or placebo target maintenance dose of 2.4 mg once weekly. Those unable to tolerate this dose will be permitted to stay at a lower dose (maximum tolerated dose). At least one attempt to re-escalate to the immediate upper dose is recommended.
Placebo weekly Injection
A 40-week randomized, placebo double-blind controlled intervention (versus semaglutide injection), followed by an open phase from weeks 40 to 80 where all participants receive semaglutide. In first 40 weeks period (between 0-40 weeks), placebo is initiated in same timing than semaglutide (in other arm). In second 40 weeks period (between 40-80 weeks), Semaglutide is initiated at a dose of 0.25 mg once weekly for the first 4 weeks, followed by escalation every 4 weeks to 0.50, 1.0, 1.70, and 2.40 mg. The recommended target maintenance dose of semaglutide or placebo is 2.4 mg once weekly. Participants are encouraged to reach the recommended semaglutide or placebo target maintenance dose of 2.4 mg once weekly. Those unable to tolerate this dose will be permitted to stay at a lower dose (maximum tolerated dose). At least one attempt to re-escalate to the immediate upper dose is recommended.
Locations (17)
Service Endocrinologie pédiatrique, Angers University Hospital
Angers, France
Endocrinologie Pédiatrique, University hospital of Besançon
Besançon, France
Service d'endocrinologie, diabétoglogie et obésité pédiatrique, Bordeaux University Hospital
Bordeaux, France
Endocrinologie Pédiatrique, Hôpital Femme Mere Enfants, Lyon University Hospital
Bron, France
Département de Pédiatrie, Dijon University Hospital
Dijon, France
Service de Pédiatrie, Grenoble University Hospital
La Tronche, France
Endocrinologie et diabète de l'enfant, Hopital Bicêtre, Paris University Hospital
Le Kremlin-Bicêtre, France
Endocrinologie, diabète et obésité pédiatrique, Lille University Hospital
Lille, France
Service de pédiatrie multidisciplinaire, Hopital La Timone, Marseille University Hospital
Marseille, France
Service de diabétologie et endocrinologie pédiatriques
Montpellier, France
Unité Endocrinologie et Diabète, Nancy University hospital
Nancy, France
Endocrinologie, diabétologie et Gynécologie pédiatrique, Necker Hospital, Paris University Hospital
Paris, France
Service d'endocrinologie diabétologie pédiatrique, Paris University Hospital
Paris, France
Service de Pédiatrie A, Reims University Hospital
Reims, France
Unité d'Endocrinologie et Diabétologie Pédiatriques, Rennes University Hospital
Rennes, France
Service de Pédiatrie, Strasbourg University Hospital
Strasbourg, France
Unité d'Endocrinologie, Maladies Osseuses et Génétique, Toulouse University Hospital
Toulouse, France