A weekly shot tested for fast weight gain in teens after a brain tumor
Official title: 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
Status: Not yet recruiting. It has not opened yet. Ask your care team to watch for it if it looks like a fit.
The trial team last updated this record on .
The short version
This trial tests a weekly shot for teens who gained weight after a brain tumor.
Read our full plain-language summary
What the trial team says
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 facts
- Registry number
- NCT07845994
- Stage of testing
- Phase 3
- Conditions studied
- Craniopharyngioma, Child
Where it is running
This trial lists 17 sites.
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France
- Service Endocrinologie pédiatrique, Angers University Hospital (Angers)
- Endocrinologie Pédiatrique, University hospital of Besançon (Besançon)
- Service d'endocrinologie, diabétoglogie et obésité pédiatrique, Bordeaux University Hospital (Bordeaux)
- Endocrinologie Pédiatrique, Hôpital Femme Mere Enfants, Lyon University Hospital (Bron)
- Département de Pédiatrie, Dijon University Hospital (Dijon)
- Service de Pédiatrie, Grenoble University Hospital (La Tronche)
- Endocrinologie et diabète de l'enfant, Hopital Bicêtre, Paris University Hospital (Le Kremlin-Bicêtre)
- Endocrinologie, diabète et obésité pédiatrique, Lille University Hospital (Lille)
- Service de pédiatrie multidisciplinaire, Hopital La Timone, Marseille University Hospital (Marseille)
- Service de diabétologie et endocrinologie pédiatriques (Montpellier)
- Unité Endocrinologie et Diabète, Nancy University hospital (Nancy)
- Endocrinologie, diabétologie et Gynécologie pédiatrique, Necker Hospital, Paris University Hospital (Paris)
- and 5 more in France
How to use this
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This page is built from the trial's listing on ClinicalTrials.gov, a service of the U.S. National Library of Medicine. That listing is the authority, and it may have changed since we last read it. We do not run this trial and we cannot enroll you in it.