Not recruiting

Study on the Effects of Semaglutide for Weight Management in Children and Adolescents with Obesity or Overweight

Fast replyRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying the effects of a medication called semaglutide on managing weight in children and teenagers who are dealing with obesity or are overweight. The medication, known by the brand name Wegovy, is administered as a solution for injection using a pre-filled pen. The study aims to determine how well semaglutide, when used alongside a reduced-calorie diet and increased physical activity, can help manage weight in young individuals aged 6 to under 18 years.

Participants in the study will receive semaglutide injections once a week. The study will compare the effects of semaglutide with a placebo, which is a substance with no active medication, to see if semaglutide is more effective in helping children and teenagers lose weight. The study will last for a period of up to 104 weeks, during which participants will be monitored for changes in their body mass index (BMI), weight, and other health indicators.

The goal of the study is to confirm whether semaglutide is superior to a placebo in aiding weight management in children with obesity. The study will also look at improvements in weight categories based on growth charts specific to age and sex, as well as changes in other health markers such as blood pressure and cholesterol levels. This research is important for understanding how semaglutide can be used as a treatment option for young people struggling with obesity and overweight issues.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of the trial
Upon joining the study, the participant will start with a baseline assessment. This includes measuring the body mass index (BMI) and other health indicators. This step is crucial to establish the starting point for the trial.
Step 2
Medication administration
The participant will receive a medication called semaglutide, which is administered as a subcutaneous injection (an injection under the skin).
The dosage will start at 0.25 mg once a week and will gradually increase over time. The participant will eventually receive a dose of 2.4 mg once a week.
The medication is provided in a pre-filled pen called Wegovy.
Step 3
Diet and physical activity
Participants are encouraged to follow a reduced-calorie diet and increase their physical activity as part of the trial. This is to support weight management efforts alongside the medication.
Step 4
Regular check-ups
Throughout the trial, participants will have regular check-ups to monitor their progress. These check-ups will include measuring changes in BMI and other health indicators.
The primary goal is to observe changes from the baseline to week 68 and further to week 104.
Step 5
End of the trial
The trial is expected to conclude by January 15, 2027. At the end of the trial, a final assessment will be conducted to evaluate the overall impact of the treatment on weight management.

Who can join the trial?

9 criteria

The parent(s) or legally acceptable representative (LAR) of the child must give their informed consent before any study-related activities begin. This means they agree to let their child participate in the study. The child must also agree to participate, either by signing a form or giving oral consent.
The child must be between the ages of 6 and less than 12 years old for Group Kids, or between 12 and less than 18 years old for Group Teens. For Group Teens, the child must also be at Tanner stage greater than 1, which is a measure of physical development.
The child's Body Mass Index (BMI) must be at or above the 95th percentile for their age and gender. For Group Teens, if the BMI is between the 85th and 95th percentile, the child must have at least one weight-related health issue, such as high blood pressure, abnormal cholesterol levels, sleep apnea, or type 2 diabetes (T2D).
The child must have a history of at least one unsuccessful attempt to lose weight through a structured program that includes diet and exercise counseling for at least 3 months.
The child must weigh more than 45 kg (about 99 pounds) at the time of screening and randomization.
If the child has type 2 diabetes, they must be treated with lifestyle changes or metformin, a medication for diabetes, and this treatment must be stable for at least 90 days before screening.
If the child has type 2 diabetes, their HbA1c level, which is a measure of blood sugar control, must be 10.0% or lower at screening.
If the child is assessed by a DXA scan, which is a type of imaging test to measure body composition, the scan must be evaluated and found acceptable by the imaging laboratory before randomization.
If the child is assessed by a DXA scan, their BMI must be 40.0 kg/m² or lower at screening.

Who cannot join the trial?

8 criteria

Children who are not between the ages of 6 and 12 years old cannot participate.
Children who do not have **obesity** or are not **overweight** cannot participate.
Children who cannot follow a reduced-calorie diet or increase physical activity cannot participate.
Children who have any medical condition that the study doctors think might make it unsafe for them to participate cannot join the study.
Children who are taking medications that might interfere with the study cannot participate.
Children who have participated in another clinical trial recently may not be eligible.
Children who are pregnant or breastfeeding cannot participate.
Children who have a history of certain medical conditions, such as severe heart disease or uncontrolled diabetes, cannot participate.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Aalborg University Hospital
Aalborg, Denmark
Responsive
Katholieke Universiteit te Leuven
Leuven, Belgium
Responsive
Region Midtjylland
Aarhus, Denmark

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Semaglutide is a medication used in this clinical trial to help manage weight in children and adolescents who are overweight or have obesity. It is given as an injection under the skin once a week. The goal of using semaglutide in this study is to see if it can help reduce weight when combined with a diet that has fewer calories and increased physical activity. The trial aims to confirm that semaglutide is more effective than not using any active medication (placebo) in helping children manage their weight.

Semaglutide

What is already known about the treatment

Semaglutide – Semaglutide is administered as a once-weekly injection under the skin, known as subcutaneous administration. It is currently being studied for its effectiveness and safety in managing weight in children and adolescents with obesity or overweight. The main therapeutic use of semaglutide is to help with weight management, especially when combined with a reduced-calorie diet and increased physical activity. At the molecular level, semaglutide works by mimicking a hormone in the body that helps regulate appetite and food intake, leading to reduced hunger and calorie consumption. It is classified pharmacologically as a GLP-1 receptor agonist, which means it activates specific receptors in the body to produce its effects.

Investigated diseases

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may negatively impact health. It develops when calorie intake consistently exceeds calorie expenditure, leading to an energy imbalance. Over time, this excess energy is stored as fat, resulting in increased body weight and body mass index (BMI). As obesity progresses, it can lead to changes in body composition, including increased fat mass and altered distribution of fat. This condition can also affect metabolic processes, potentially leading to changes in blood pressure, cholesterol levels, and insulin sensitivity. Obesity can further influence physical activity levels and overall quality of life.