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A study on the effectiveness of cagrilintide and semaglutide for weight management in children and adolescents with obesity

Fast replyInvestigationalNo placebo
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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 Obesity and Type 2 Diabetes, which is a condition where the body cannot properly use blood sugar. The research aims to evaluate the effectiveness and safety of different treatment options for weight management. The medications being studied include cagrilintide, semaglutide, and a combination of both known as CagriSema. These treatments are administered via subcutaneous injection, which means the medicine is injected into the fatty layer just under the skin.

Participants in the study may receive cagrilintide alone, the combination of cagrilintide and semaglutide, semaglutide alone, or a placebo. The study involves monitoring changes in Body Mass Index, which is a measurement used to determine if a person has a healthy weight for their height, and the BMI Standard Deviation Score, a calculation that compares a person's body mass to the average for others of the same age and sex. The course of the study involves weekly injections over a period of time to observe how these substances affect body weight and overall health.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment phase

    During the 68-week treatment period, a weekly subcutaneous injection (an injection given under the skin) is administered.

    The subcutaneous injection will consist of one of the following options: cagrilintide, semaglutide, cagrilintide and semaglutide (known as CagriSema), or a placebo (an inactive substance that does not contain medication).

  2. Step 2

    Monitoring and evaluation

    The progress of body mass index (a measure of body fat based on height and weight) and body weight is monitored from the start of the treatment through week 68.

    Changes in the bmi standard deviation score (a way to compare weight to other individuals of similar age and sex) are also recorded during this period.

Who can join the trial?

12 criteria

  • The parents or a legal guardian must sign a document called informed consent, which means they give permission for the child to join the study after understanding all the details.
  • The child must also provide assent, which is a way of showing they agree to participate in the study in a way that is appropriate for their age.
  • The participant can be any gender (male or female).
  • The child must be between 8 and 17 years old at the time the permission forms are signed.
  • Children aged 8 to 11 must have a Body Mass Index (BMI)—a measure of body fat based on height and weight—that is at or above the 95th percentile, meaning their weight is higher than 95% of other children their age.
  • Adolescents aged 12 to 17 must have a BMI at or above the 95th percentile, or at or above the 85th percentile if they also have an obesity-related complication, such as type 2 diabetes (a condition where the body cannot properly control blood sugar), hypertension (high blood pressure), dyslipidaemia (unhealthy levels of fats/cholesterol in the blood), or obstructive sleep apnoea (a condition where breathing repeatedly stops and starts during sleep).
  • Blood tests must show that levels of calcium, phosphate, alkaline phosphatase, and parathyroid hormone (minerals and hormones that help manage bone and blood levels) are within the normal range for the child's age and sex.
  • The participant must have tried to lose weight through a structured lifestyle modification programme (a planned program of healthy eating and physical activity) for at least 3 months without success.
  • The child's weight must be greater than 45 kg at the start of the study.
  • The HbA1c level, which is a blood test that shows the average blood sugar levels over the past few months, must be 10.0% or lower.
  • The child must be currently using a lifestyle intervention (healthy eating and exercise plans) or taking a medication called metformin.
  • If taking metformin, the dose and how often it is taken must have remained the same for at least 56 days before the study begins.

Who cannot join the trial?

13 criteria

  • Taking any medicine for obesity (being significantly overweight) or weight management within 90 days before starting the study.
  • Having frequent and severe hypoglycaemic episodes, which means sudden and dangerous drops in blood sugar levels, within 1 year before starting the study.
  • Testing positive for IA-2 antibodies or anti-GAD antibodies, which are specific markers in the blood that can indicate certain types of diabetes.
  • Taking any medicine for diabetes other than the ones specifically allowed in the study within 90 days before starting.
  • Having uncontrolled diabetic retinopathy or maculopathy, which are eye problems caused by diabetes that affect vision and are not currently stable or well-managed.
  • Having had, or planning to have, obesity surgery or using a weight loss device during the study, though certain procedures like liposuction or gastric bands are allowed if they were completed more than 1 year ago.
  • Having uncontrolled thyroid disease, which is a condition where the thyroid gland does not produce the right amount of hormones to regulate the body.
  • Having obesity caused by endocrine, hypothalamic, or syndromic issues, which means weight gain related to hormone imbalances or specific genetic conditions.
  • Having lost or gained more than 5% of your total body weight within the 90 days before starting the study.
  • Having Type 1 diabetes or monogenic diabetes, which are specific types of diabetes caused by different biological mechanisms than common Type 2 diabetes.
  • Having an HbA1c level of 6.5% or higher, which is a blood test that shows your average blood sugar levels over the past few months.
  • Taking any glucose-lowering agents, which are medicines used to reduce high blood sugar, for diabetes or pre-diabetes within 90 days before starting.
  • Having hypoglycaemic unawareness, which means you are unable to feel or notice the warning signs when your blood sugar levels drop too low.
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Investigated drugs

  • Cagrilintide

    is a medication given as a weekly injection under the skin. It is being studied to see how well it works on its own to help manage weight.

  • Semaglutide

    is a medication given as a weekly injection under the skin. In this study, it is used as a comparison to help evaluate the effectiveness of the other treatments.

  • Cagrilintide semaglutide

    is a combination treatment that includes two different medications given together in a single weekly injection under the skin. This combination is being tested to see if it is more effective for weight management than the individual medications or a placebo.

What is already known about the treatment

  • Cagrilintide

    This medication is an experimental injectable solution administered once a week through a needle under the skin. It is being studied for its ability to help manage weight in individuals with overweight or obesity. At a molecular level, it works as an amylin analogue by mimicking a natural hormone to signal fullness to the brain and slow down digestion. This substance is classified as a metabolic hormone analogue.

  • Semaglutide

    This is an established medication provided as an injection under the skin once per week. It is widely used in medical practice to treat type 2 diabetes and to assist with weight management. It works by targeting and activating specific receptors in the body that regulate blood sugar and appetite, essentially mimicking a natural hormone. Pharmacologically, it is classified as a glucagon-like peptide-1 (GLP-1) receptor agonist.

Investigated diseases

Obesity - This condition involves an excessive accumulation of body fat that may impair health. It often develops over time due to an imbalance between energy intake from food and energy expenditure. The condition can progress as weight increases, leading to various metabolic changes. Type 2 diabetes mellitus - This is a chronic condition that affects how the body processes blood sugar. It occurs when the body either resists the effects of insulin or does not produce enough of it to maintain normal glucose levels. Over time, blood sugar levels can rise steadily if the condition is not managed.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase ITrial ID2023-509176-42-00Protocol codeNN9838-4968Estimated enrolment460 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).