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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>treatment initiation and dose escalation</b>

    The treatment phase begins with a dose escalation period lasting 16 weeks. during this time, the amount of medicine is gradually increased.

    The medicine is semaglutide, which is administered via a subcutaneous injection, meaning it is injected under the skin using a pre-filled pen.

    One group receives semaglutide, while another group receives a placebo, which is an inactive substance that looks like the medicine but contains no active ingredients.

  2. Step 2

    <b>maintenance phase</b>

    Following the initial 16 weeks, a maintenance phase occurs for 24 weeks.

    The dose of semaglutide is kept at a maximum maintenance dose of 2.4 mg administered once every week.

  3. Step 3

    <b>assessment at 40 weeks</b>

    At 40 weeks, the change in body mass index (bmi) is evaluated. bmi is a measure used to assess body weight in relation to height.

  4. Step 4

    <b>extended follow-up</b>

    The study continues to compare those who started semaglutide at the beginning with those who may have a delayed initiation.

    The final assessment of bmi changes is conducted at 80 weeks.

Who can join the trial?

9 criteria

  • 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 trial?

16 criteria

  • 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.
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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.

What is already known about the treatment

  • Semaglutide

    This medication is an injectable solution administered once weekly through a small needle under the skin. It is an established treatment used to manage weight and blood sugar levels by mimicking a natural hormone that tells the brain to feel full and helps the body release insulin. At a molecular level, it works by attaching to and activating specific receptors in the gut and brain to regulate appetite and energy use. It is classified as a glucagon-like peptide-1 (GLP-1) receptor agonist.

  • Semaglutide Placebo

    This is an inactive substance administered via a subcutaneous injection using the same pre-filled pen method as the active medication. It contains no medicinal ingredients and is used in clinical trials as a control to ensure that the observed effects are truly caused by the test drug. It serves no therapeutic purpose and is used strictly for scientific comparison during the study.

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 detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-511114-20-00Protocol code49RC23_0307Estimated enrolment50 patientsSponsorCentre Hospitalier Universitaire D'Angers

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