A study to evaluate the effectiveness of semaglutide for treating obesity caused by craniopharyngioma in children aged 12 to 17 years.

3 1 1

What is this study about?

This study focuses on hypothalamic obesity, which is a type of extreme weight gain caused by damage to the hypothalamus, the part of the brain that controls hunger and energy use. This condition often occurs after a person has been treated for a craniopharyngioma, which is a rare, non-cancerous tumor located near the pituitary gland at the base of the brain. The purpose of the study is to evaluate the effectiveness of semaglutide in managing weight in children and teenagers with this condition.

Participants will be assigned to receive either semaglutide or a placebo through a subcutaneous injection, which is a medical procedure where medicine is injected into the fatty layer just under the skin. Over the course of the study, some participants will receive the medication immediately, while others may experience a delay before starting the treatment. The amount of medicine will be increased gradually over several weeks until a stable dose is reached to ensure safety and effectiveness.

Who Can Join the Study?

  • You must be between 12 and 17 years old.
  • You must have had a craniopharyngioma, which is a type of tumor located near the brain’s center, that was treated with surgery.
  • Your last surgery to remove the solid part of the tumor must have occurred more than 6 months ago, and the tumor must be considered stable, meaning it is not growing or changing.
  • You must be taking the necessary pituitary replacement medicines, which are hormones used to replace those the brain can no longer produce, including growth hormone if needed.
  • Your BMI (Body Mass Index, a measure of body weight relative to height) must be more than 2 standard deviations above the average for your age and sex in France, or you must have gained weight equal to more than 1 standard deviation over the last 6 to 12 months.
  • You must have been unable to control your weight for at least six months, despite following strict dietary guidelines and physical activity advice from a professional.
  • Female patients who have started their menarche (the first menstrual period) naturally and are not using estrogen hormones must use highly effective contraception (methods to prevent pregnancy) during the study and for 7 weeks after the last dose.
  • You must have medical care assurance, which means you have health insurance coverage.
  • Your parents or legal representatives must provide written consent, and you must also agree to participate.

Who Cannot Join the Study?

  • Using any other weight loss treatments within the 90 days before being checked for the study.
  • Having a history of pancreatitis, which is an inflammation or swelling of the pancreas (an organ located behind the stomach that helps with digestion).
  • Having a severe psychiatric disorder, which refers to serious mental health conditions such as schizophrenia (a condition affecting how a person thinks, feels, and behaves) or bipolar disorder (a condition that causes extreme mood swings).
  • Having mental retardation, which is a term used to describe significant limitations in intellectual functioning and daily life skills.
  • Having a history of suicidal attempt at any point in life.
  • A history of NEM2 (a genetic condition that causes tumors), medullary thyroid carcinoma (a specific type of cancer found in the thyroid gland), malignant neoplasms (cancerous growths), carcinomas in situ (early-stage cancer that has not spread), or uncontrolled thyroid disease (a condition where the thyroid gland is not working properly and cannot be managed).
  • Being unable to understand the details of the study.
  • Having a calcitonin level of 50 ng/L or higher (calcitonin is a hormone produced by the thyroid gland).
  • Having major problems with compliance, which means the ability to follow the rules or instructions of the medical treatment.
  • Any other medical condition or unwillingness to participate that, in the doctor’s opinion, could make the study unsafe or make it difficult to follow the rules.
  • Known or suspected use of alcohol or recreational drugs.
  • A history of type 1 or type 2 diabetes (conditions involving high blood sugar levels).
  • Taking part in another interventional research study, which is a medical study where participants receive a specific treatment or intervention.
  • Being pregnant, wanting to become pregnant, breast-feeding, or having recently given birth.
  • Having had previous surgical treatment for obesity (surgery performed to help lose weight).
  • Having any other chronic diseases, which are long-lasting health conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Hopital Necker Enfants Malades Paris France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Cvisxc Heidtxuipqe Uausemyinlerx Rseoa Reims France
Ahajpgcjve Pjiikirc Hlhgvomm Dk Mdfcoxtcp Marseille France
Bgzrcwns Ufmdxyqgpa Hpnrriyu Cngksr Besançon France
Ctwnce Hafrtvvqvpd Rqherfzl Dhrpesvceemrhk Angers France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.06.2026

Trial locations

Investigated drugs:

Semaglutide is a medication given as an injection under the skin. It is being studied to see how well it can help manage weight in children and teenagers who have obesity caused by a specific type of brain tumor.

Investigated diseases:

Craniopharyngioma – This is a type of tumor that grows near the pituitary gland and the hypothalamus in the brain. As the tumor increases in size, it can press against these important areas, disrupting the body’s natural signals. This disruption often affects how the brain regulates hunger and energy use. Consequently, many individuals develop hypothalamic obesity, which is a significant increase in body weight. The condition progresses as the tumor continues to interfere with hormonal control.

Trial ID:
2024-511114-20-00
Protocol code:
49RC23_0307
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A Study of Dabrafenib and Trametinib Treatment Before and After Surgery in Patients with Papillary Craniopharyngioma

    Recruiting

    2 1 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden
  • A study of tovorafenib for children and young adults with newly diagnosed or recurrent craniopharyngioma

    Not yet recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany The Netherlands