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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. září 2026 aktualizováno: 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).

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Odhadovaný)

50

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Regis COUTANT, Professor of Medecine
  • Telefonní číslo: + 33 (0)2 41 35 56 55
  • E-mail: ReCoutant@chu-angers.fr

Studijní záloha kontaktů

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

12 let až 17 let (Dítě)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Komparátor placeba: PLACEBO
Lék: 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.
Experimentální: SEMAGLUTIDE
Lék: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in BMI SD score (according to french references) at 40 weeks
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in BMI in kg/m at 40 weeks compared between semaglutide and placebo
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University Hospital, Angers

Vyšetřovatelé

  • Vrchní vyšetřovatel: Régis COUTANT, Professor of Medecine, University Hospital of Angers

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. listopadu 2026

Primární dokončení (Odhadovaný)

1. února 2031

Dokončení studie (Odhadovaný)

1. února 2031

Termíny zápisu do studia

První předloženo

31. srpna 2026

První předloženo, které splnilo kritéria kontroly kvality

22. září 2026

První zveřejněno (Aktuální)

29. září 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

29. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

22. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

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

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

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