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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)

2026年9月22日 更新者：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).

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

50

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Regis COUTANT, Professor of Medecine
  • 电话号码：+ 33 (0)2 41 35 56 55
  • 邮箱：ReCoutant@chu-angers.fr

研究联系人备份

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 至 17年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：安慰剂
药品：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.
实验性的：SEMAGLUTIDE
药品：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in BMI SD score (according to french references) at 40 weeks
大体时间：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
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Change in BMI in kg/m at 40 weeks compared between semaglutide and placebo
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University Hospital, Angers

调查人员

  • 首席研究员：Régis COUTANT, Professor of Medecine、University Hospital of Angers

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年11月1日

初级完成 (估计的)

2031年2月1日

研究完成 (估计的)

2031年2月1日

研究注册日期

首次提交

2026年8月31日

首先提交符合 QC 标准的

2026年9月22日

首次发布 (实际的)

2026年9月29日

研究记录更新

最后更新发布 (实际的)

2026年9月29日

上次提交的符合 QC 标准的更新

2026年9月22日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 49RC23_0307
  • 2024-511114-20-00 (克蒂斯)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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