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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 (SEMAFORCRANIO)

22 settembre 2026 aggiornato da: University Hospital, Angers

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).

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

50

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Regis COUTANT, Professor of Medecine
  • Numero di telefono: + 33 (0)2 41 35 56 55
  • Email: ReCoutant@chu-angers.fr

Backup dei contatti dello studio

Luoghi di studio

  • Francia
      • Angers, Francia
        • Service Endocrinologie pédiatrique, Angers University Hospital
        • Contatto:
      • Besançon, Francia, 25030
        • Endocrinologie Pédiatrique, University hospital of Besançon
        • Contatto:
      • Bordeaux, Francia
        • Service d'endocrinologie, diabétoglogie et obésité pédiatrique, Bordeaux University Hospital
        • Contatto:
      • Bron, Francia
        • Endocrinologie Pédiatrique, Hôpital Femme Mere Enfants, Lyon University Hospital
        • Contatto:
      • Dijon, Francia
        • Département de Pédiatrie, Dijon University Hospital
        • Contatto:
      • La Tronche, Francia
        • Service de Pédiatrie, Grenoble University Hospital
        • Contatto:
      • Le Kremlin-Bicêtre, Francia
        • Endocrinologie et diabète de l'enfant, Hopital Bicêtre, Paris University Hospital
        • Contatto:
      • Lille, Francia
        • Endocrinologie, diabète et obésité pédiatrique, Lille University Hospital
        • Contatto:
      • Marseille, Francia
        • Service de pédiatrie multidisciplinaire, Hopital La Timone, Marseille University Hospital
        • Contatto:
      • Montpellier, Francia
        • Service de diabétologie et endocrinologie pédiatriques
        • Contatto:
      • Nancy, Francia
        • Unité Endocrinologie et Diabète, Nancy University hospital
        • Contatto:
      • Paris, Francia
        • Endocrinologie, diabétologie et Gynécologie pédiatrique, Necker Hospital, Paris University Hospital
        • Contatto:
      • Paris, Francia
        • Service d'endocrinologie diabétologie pédiatrique, Paris University Hospital
        • Contatto:
      • Reims, Francia
        • Service de Pédiatrie A, Reims University Hospital
        • Contatto:
          • Aurélie BEROT, Doctor of Medecine
          • Numero di telefono: +33(0)3.26.78.94.78
          • Email: aberot@chu-reims.fr
      • Rennes, Francia
        • Unité d'Endocrinologie et Diabétologie Pédiatriques, Rennes University Hospital
        • Contatto:
      • Strasbourg, Francia
        • Service de Pédiatrie, Strasbourg University Hospital
        • Contatto:
      • Toulouse, Francia
        • Unité d'Endocrinologie, Maladies Osseuses et Génétique, Toulouse University Hospital
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 12 anni a 17 anni (Bambino)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: PLACEBO
Droga: 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.
Sperimentale: SEMAGLUTIDE
Droga: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in BMI SD score (according to french references) at 40 weeks
Lasso di tempo: 40 weeks

Co-primary 1 (S40 - RCT): Change in BMI (in SD for age and sex according to French references) after 40 weeks of treatment with semaglutide (dose escalation over 16 weeks followed by a maintenance dose of 2.4 mg/week for 24 weeks) compared to placebo
40 weeks
Change in BMI SD score (according to french references) at 80 weeks
Lasso di tempo: 80 weeks

Co-primary 2 (S80 - delayed-start): Change in BMI-SD from baseline to S80: "semaglutide group starting at S0" vs "semaglutide group starting at S40"
80 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in BMI in kg/m at 40 weeks compared between semaglutide and placebo
Lasso di tempo: 40 weeks

Evaluation of the variation in Body Mass Index (BMI), expressed in kg/m², from baseline (inclusion) to week 40. This will be compared between two groups: one receiving Semaglutide from the start of the study and the other receiving a placebo for the initial 40 weeks
40 weeks
Change in BMI in kg/m at 80 weeks between compared between semaglutide and placebo
Lasso di tempo: 80 weeks

Evaluation of the variation in BMI, expressed in kg/m², from baseline (inclusion) to week 80. This will be compared between two groups: one receiving Semaglutide from the start of the study and the other receiving a placebo for the initial 40 weeks
80 weeks
Intra-individual progression of BMI-DS at each visit depending on Semaglutide treatment
Lasso di tempo: 80 weeks

Intra-individual progression of BMI-SDS values measured at the scheduled visits outlined in the protocol from week 0 to week 80 depending on Semaglutide treatment periods.
80 weeks
Effects of 40 weeks of weekly semaglutide treatment on height
Lasso di tempo: 40 weeks

Comparison of height between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
40 weeks
Effects of 40 weeks of weekly semaglutide treatment on weight
Lasso di tempo: 40 weeks

Comparison of weight between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
40 weeks
Effects of 40 weeks of weekly semaglutide treatment on waist circumference
Lasso di tempo: 40 weeks

Comparison of waist circumference between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
40 weeks
Effects of 40 weeks of weekly semaglutide treatment on arterial blood pressure
Lasso di tempo: 40 weeks

Comparison of arterial blood pressure between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
40 weeks
Effects of 40 weeks of weekly semaglutide treatment on fasting blood glucose
Lasso di tempo: 40 weeks

Comparison of fasting blood glucose between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
40 weeks
Effects of 40 weeks of weekly semaglutide treatment on HbA1C
Lasso di tempo: 40 weeks

Comparison of HbA1C between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
40 weeks
Effects of 40 weeks of weekly semaglutide treatment on insulin level
Lasso di tempo: 40 weeks

Comparison of insulin level between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
40 weeks
Effects of 40 weeks of weekly semaglutide treatment on cholesterol
Lasso di tempo: 40 weeks

Comparison of cholesterol between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
40 weeks
Effects of 40 weeks of weekly semaglutide treatment on triglycerides
Lasso di tempo: 40 weeks

Comparison of triglycerides between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
40 weeks
Effects of 40 weeks of weekly semaglutide treatment on body composition
Lasso di tempo: 40 weeks

Comparison of body composition (by DEXA) between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
40 weeks
Effects of 40 weeks of weekly semaglutide treatment on bone age
Lasso di tempo: 40 weeks

Comparison of bone age (by X-ray of the left hand and wrist) between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
40 weeks
Effects of 40 weeks of weekly semaglutide treatment on quality of life by PedsQL questionnaire
Lasso di tempo: 40 weeks

Comparison of quality of life by PedsQL questionnaire score between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
40 weeks
Effects of 40 weeks of weekly semaglutide treatment on quality of life by Epworth Sleepiness Scale
Lasso di tempo: 40 weeks

Comparison of quality of life by Epworth Sleepiness Scale score between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
40 weeks
Effects of 40 weeks of weekly semaglutide treatment on quality of life by IWQOL-Kids questionnaire
Lasso di tempo: 40 weeks

Comparison of quality of life by IWQOL-Kids score between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
40 weeks
Effects of 40 weeks of weekly semaglutide treatment on quality of life by Dykens Hyperphagia questionnaire
Lasso di tempo: 40 weeks

Comparison of quality of life by Dykens Hyperphagia questionnaire score between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
40 weeks
Effects of 40 weeks of weekly semaglutide treatment on quality of life by Daily Hunger Score
Lasso di tempo: 40 weeks

Comparison of quality of life by Daily Hunger Score score between patient with 40 weeks of weekly semaglutide treatment (dose escalation over 16 weeks followed by a maximum maintenance dose of 2.4 mg/week during 24 weeks depending on treatment tolerance) versus placebo
40 weeks
Safety between 2 arms
Lasso di tempo: 80 weeks

Comparison of the incidence of each category of adverse events (AE) between the two arms (semaglutide versus placebo).
80 weeks
Kinetics of BMI-DS evolution
Lasso di tempo: End of study V10 (106 weeks)

Difference in the kinetics of BMI (in DS) evolution depending on whether it occurs in the presence or absence of semaglutide
End of study V10 (106 weeks)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University Hospital, Angers

Investigatori

  • Investigatore principale: Régis COUTANT, Professor of Medecine, University Hospital of Angers

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 novembre 2026

Completamento primario (Stimato)

1 febbraio 2031

Completamento dello studio (Stimato)

1 febbraio 2031

Date di iscrizione allo studio

Primo inviato

31 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

22 settembre 2026

Primo Inserito (Effettivo)

29 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 49RC23_0307
  • 2024-511114-20-00 (Ctis)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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