A Research Study on How Well Semaglutide Helps Children and Teenagers With Excess Body Weight Lose Weight
This research study is investigating semaglutide, a medicine that's already approved for adults with type 2 diabetes and for weight management, to see if it can help children and teenagers with excess body weight. Participants will receive a weekly injection of either semaglutide or a 'dummy' medicine (placebo) – chosen randomly, like flipping a coin. Alongside the medicine, children and their parents will get advice on healthy eating and increasing physical activity to help with weight loss. The medicine is given with a thin needle in the stomach, thighs, or upper arms. The study will run for about two and a half years. It aims to understand how effective semaglutide is for this age group compared to the dummy medicine plus lifestyle support.
At a glance
What is this study about?
This study is a research project looking into a medicine called semaglutide. You might have heard of semaglutide because it's already used to help adults with type 2 diabetes and for weight management. This study wants to find out if it can also help children and teenagers who have concerns about their weight to lose weight. We know that maintaining a healthy weight is really important for young people's overall health and well-being.
Taking part would mean you or your child would be given a weekly injection of either semaglutide or a 'dummy' medicine, called a placebo. A placebo looks exactly like the real medicine but contains no active drug. This is done to fairly compare the effects of semaglutide against what happens without the active medicine, while everyone still receives support and advice. Neither you nor the study team will know which treatment your child is receiving until the end of the study. Everyone in the study, whether they get semaglutide or the dummy medicine, will also receive helpful talks and advice from the study team about making healthy food choices, being more active, and other ways to try and lose weight.
The injections are given once a week using a very thin needle, typically in the tummy, thighs, or upper arms. The study is designed to run for a total of two and a half years (about 132 weeks). This longer timeframe helps the researchers understand the effects of the medicine over a sustained period and gather important information safely.
Key takeaways
- A research study testing a medicine called semaglutide for weight loss in children and teenagers.
- Participants will receive weekly injections of either semaglutide or a dummy medicine.
- All participants will get support and advice on healthy eating and activity levels.
- The study lasts around 2.5 years and involves regular health checks.
- Participation is voluntary, and you can withdraw your child at any time.
Who may be eligible?
For your child to be considered for this study, they need to meet certain requirements. They should be between 6 and 18 years old. Their body mass index (BMI), which is a measure of weight relative to height, needs to be above a certain level that suggests excess body weight for their age. Also, they should have tried to lose weight before using a structured programme of diet and exercise for at least three months, but without success.
If your child is aged 12 or over, they might also be eligible if their BMI is slightly lower but they have a weight-related health issue like high blood pressure, high cholesterol, sleep apnoea (breathing problems during sleep), or type 2 diabetes. If they have type 2 diabetes, their sugar levels need to be within a certain range.
There are also some reasons why your child might not be able to join. For example, if they have used other weight loss medicines in the last three months, or if they have had weight loss surgery or plans to have it during the study. The study team will review all this information to see if your child is a good fit.
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.
- Is your child aged between 6 and 18 years old?
- Does your child have a BMI (weight relative to height) that is considered high for their age?
- Has your child tried to lose weight for at least 3 months through diet and exercise, without enough success?
- Is your child willing to have a weekly injection?
- Has your child avoided other weight loss medicines in the last 3 months?
- Has your child not had or planned any weight loss surgery?
What does participation involve?
If your child takes part, they will come to regular appointments over about two and a half years (132 weeks). At these visits, their health will be checked, and they will receive their weekly study medicine, which is given as an injection. They’ll also have regular talks with the study team about healthy eating and being more active. Blood tests and other health checks will be done throughout the study to monitor their progress and safety. There will be an initial screening to see if your child is suitable, followed by the treatment period, and then a follow-up period after they stop taking the study medicine.
Potential risks and benefits
Locations (56)
- Neighborhood HealthcareVerified postcodeEscondido, United States
- Yale School of MedicineVerified postcodeNew Haven, United States
- Columbus Research FoundationVerified postcodeColumbus, United States
- Eastside Bariatric and Gen SurgVerified postcodeSnellville, United States
- Solaris Clinical ResearchVerified postcodeMeridian, United States
- Pennington Biom Res CtrVerified postcodeBaton Rouge, United States
- Clinical Trials of America LLCVerified postcodeMonroe, United States
- IMA Clinical ResearchVerified postcodeMonroe, United States
- Barry J. Reiner, MD LLCVerified postcodeBaltimore, United States
- Massachusetts General Hospital_CaryVerified postcodeBoston, United States
- University of MinnesotaVerified postcodeMinneapolis, United States
- Mississippi Center for Advanced MedicineVerified postcodeMadison, United States
Common questions
What is semaglutide?
Semaglutide is a medicine that helps manage blood sugar and weight in adults. This study is checking if it can help children and teenagers too.
Will my child know if they are getting the real medicine or the dummy medicine?
No, neither you, your child, nor the study team will know who is getting which treatment until the study finishes. This ensures fair results.
How is the medicine given?
The medicine is given as a simple injection once a week, using a thin needle. It can be injected into the stomach, thighs, or upper arms.
How long will the study last?
The study will last for about two and a half years, which is roughly 132 weeks.
What kind of support will my child receive?
Your child and their parents will receive advice and talks from the study team on healthy food choices and how to be more physically active.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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