AuthorisedTherapeutic confirmatory (Phase III)Interventional

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

This study, called SEMAFORCRANIO, aims to find out if a medicine called semaglutide (also known as Wegovy) can help children and teenagers aged 12 to 17 who have weight problems because of a brain tumour called craniopharyngioma. This type of tumour can affect how the body controls weight. Participants will be given either semaglutide or a dummy medicine (placebo) as an injection. We will compare how their weight changes over 40 weeks. The medicine dose will slowly increase over 16 weeks, then stay at a maximum level for another 24 weeks. This is a Phase III study, meaning it's a key step to see if the treatment works and is safe.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire D'Angers

Enrolment target

Start

27 Apr 2026

Craniopharyngioma

What is this study about?

This research study, called SEMAFORCRANIO, is designed to investigate a medicine called semaglutide, which is already used to help with weight management. We want to see if it can specifically help children and teenagers aged 12 to 17 years old who experience significant weight gain due to a particular type of brain tumour called craniopharyngioma. This type of tumour can sometimes affect a part of the brain that controls appetite and how the body stores fat, leading to what doctors call 'hypothalamic obesity'.

The study aims to compare semaglutide with a 'placebo', which is a dummy injection that contains no active medicine. This comparison is really important to understand if any changes in weight are truly due to the semaglutide, rather than other factors. Finding an effective way to manage weight in these young people could significantly improve their health and quality of life.

Over the course of 40 weeks, we will carefully monitor participants' weight. The semaglutide dose will be gradually increased over the first 16 weeks to ensure their bodies adjust well, then it will stay at the highest dose for the remaining 24 weeks. This study is a 'Phase III' trial, which means it's a large and important step before a new treatment might become widely available for this specific condition.

Key takeaways

This study is for children and teenagers (12-17 years old) with weight gain from craniopharyngioma.
It tests if semaglutide (a medicine) helps manage weight compared to a dummy medicine.
Participation involves regular injections and clinic visits over 40 weeks.
It's a 'blinded' study, so you won't know if you're getting the active drug or placebo.
The study aims to find better ways to help young people with this specific health challenge.

Who may be eligible?

To be considered for this study, participants need to be children or teenagers between 12 and 17 years old. They must have a diagnosis of craniopharyngioma, which is a specific type of brain tumour that can sometimes lead to weight issues. The study is open to both boys and girls who meet these age and medical criteria.

The research team will review each potential participant carefully to make sure the study is a good fit and safe for them. This will involve checking their medical history and current health to confirm they meet all the necessary requirements for taking part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 12 and 17 years old?
Have you been diagnosed with craniopharyngioma?
Are you experiencing weight gain linked to your craniopharyngioma?
Are you able to attend regular clinic visits for about 40 weeks?
Are you comfortable with injections?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to receive either the study medicine, semaglutide, or a placebo (a dummy medicine). Both semaglutide and the placebo are given as an injection using a pre-filled pen. You won't know whether you're receiving the active medicine or the placebo, and neither will your study doctor – this is called a 'double-blind' study and helps make the results fair.

The study lasts for approximately 40 weeks. For the first 16 weeks, the dose of the medicine will slowly increase. Then, for the next 24 weeks, you'll receive a steady, maximum dose. Throughout this time, you'll have regular visits to the clinic so the study team can monitor your health, check your weight, and see how you are responding to the treatment. There will also be follow-up checks after the main treatment period to see how you are doing.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new treatment that isn't widely available yet, which might potentially help manage weight gain caused by craniopharyngioma. However, like all medicines, semaglutide can have side effects, and some people may experience discomfort from injections. There's also a chance you might receive the placebo, meaning you wouldn’t get any active medicine from the study. All potential risks and benefits will be fully explained before you choose if you want to participate. Remember, you can withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is craniopharyngioma?

Craniopharyngioma is a rare, non-cancerous brain tumour that can sometimes affect a part of the brain that controls hormones, appetite, and weight.

What is semaglutide?

Semaglutide is a medicine that helps manage blood sugar levels and can also help people lose weight. In this study, we're looking at its use specifically for weight issues linked to craniopharyngioma.

What is a placebo?

A placebo is a 'dummy' injection that looks exactly like the study medicine but contains no active ingredients. It's used to compare against the real medicine to see if the active drug is truly effective.

How is the medicine given?

The study medicine (or placebo) is given as an injection using a pre-filled pen, similar to how some people with diabetes take their insulin.

Will I know if I'm getting the real medicine or the placebo?

No, this is a 'double-blind' study, meaning neither you nor the doctors will know if you're receiving semaglutide or the placebo until after the study has finished. This helps to keep the study fair.