2024-511114-20-00招募中3 期
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
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 17
研究概览
简要总结
To evaluate the efficacy of semaglutide on the change in BMI (in standard deviations for age and sex according to French reference values) in children aged 12–17 years with hypothalamic obesity secondary to craniopharyngioma, using two randomized confirmatory comparisons: (i) at 40 weeks (semaglutide vs. placebo) and (ii) at 80 weeks (early initiation vs. delayed initiation).
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Age 12 to 17 years
- •Surgically treated craniopharyngioma whose last surgery for the solid area (non-cystic portion) of the tumor was >6 months ago and whose tumor is considered stable
- •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 (consisting of 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 the last dosing of study drug)
- •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
排除标准
- •Other weight loss treatments within 90 days before screening
- •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
- •Calcitonin ≥ 50 ng/L
- •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 and type 2 diabetes
- •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
- •Previous surgical treatment for obesity
- •Other chronic diseases
研究组 & 干预措施
Semaglutide Placebo (Wegovy 2.4 mg solution for injection in pre-filled pen
Placebo
干预措施: Semaglutide Placebo (Wegovy 2.4 mg solution for injection in pre-filled pen (Drug)
Wegovy 2.4 mg solution for injection in pre-filled pen
Test
干预措施: Wegovy 2.4 mg solution for injection in pre-filled pen (Drug)
研究者
Coordinating investigator
Scientific
Centre Hospitalier Universitaire D'Angers
研究点 (17)
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