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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
EU CTIS ID: 2024-511114-20-00
What this study is testing
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).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.