A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
This research study is investigating new medicines called CagriSema and cagrilintide. It aims to find out how effective they are in helping children and young people aged 8 to 18 who are overweight or have obesity to lose weight. Some participants will receive CagriSema, others will get cagrilintide, some will get semaglutide (an existing medicine for weight management), and some will receive a placebo, which looks like the real treatment but contains no active ingredients. The choice of treatment is made by chance. The study has a main part lasting about 18 months, and some participants can then join an extension part, making the total study time nearly five years. Like all medicines, these study drugs may have side effects.
At a glance
What is this study about?
This study is designed to explore new ways to help children and teenagers who are living with overweight or obesity. We know that managing weight can be challenging, and researchers are always looking for new treatments to support young people. This study focuses on two investigational medicines: CagriSema and cagrilintide. These are new drugs that aren't yet available for doctors to prescribe.
The main goal is to understand if these new drugs can help young people aged 8 to 18 lose weight and keep it off. The study will compare these new treatments against an existing medicine called semaglutide, which is already used for weight management in some adults and teenagers. There will also be a placebo group, where participants receive a dummy medicine that looks the same as the active treatments but doesn't have any drug in it. This helps researchers understand the true effect of the new medications.
Taking part in a study like this helps us learn more about new treatments, which could potentially help many young people in the future. It's an important step in improving health options for children and adolescents with excess body weight.
Key takeaways
- New study for children (8 to under 18) who are overweight or have obesity.
- Compares two new drugs, CagriSema and cagrilintide, to an existing drug (semaglutide) and a dummy pill (placebo).
- Participation involves regular clinic visits and health checks.
- The main study lasts about 1.5 years, with an optional extension for longer.
- All medications have potential side effects; these will be explained.
- Participation is voluntary, and you can leave the study at any time.
Who may be eligible?
To be considered for this study, children and teenagers must be between 8 and less than 18 years old. They need to be identified as overweight or having obesity, based on their body mass index (BMI). For younger participants (8 to under 12), their BMI needs to be in the top 5% for their age and sex. For older participants (12 to under 18), their BMI needs to be in the top 5%, or in the top 15% if they also have certain health issues linked to obesity, like type 2 diabetes or high blood pressure.
Participants should have tried to lose weight before through a structured diet and exercise program for at least three months, but without enough success. They also need to weigh more than 45 kilograms (about 7 stone 1 pound). If a participant has type 2 diabetes, their blood sugar levels need to be stable and within specific limits, and they should be managing their diabetes with lifestyle changes or metformin, with their medication dose stable for at least 56 days.
Before taking part, parents or legal guardians must give their informed consent, meaning they understand and agree to the study. The child or teenager also needs to agree to take part, either in writing or verbally, depending on their age and local rules.
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.
- Are you between 8 and 17 years old?
- Have you tried a structured diet and exercise plan for at least 3 months to lose weight, without enough success?
- Do you weigh more than 45 kilograms (about 7 stone 1 pound)?
- Have your parents or legal guardians agreed to your participation, and have you also agreed if you're old enough?
What does participation involve?
If you join this study, it will involve some regular visits to the clinic. You'll receive one of the study treatments – either CagriSema, cagrilintide, semaglutide, or a placebo – which will be chosen by chance, like flipping a coin. You won't know which one you're getting, and neither will your local study team, to make sure the results are fair. You'll have various health checks and tests throughout the study to monitor your health and how you're responding to the treatment.
The main part of the study will last for about one and a half years (18 months). After this, some participants will have the option to continue into an extension part of the study for a longer period, bringing the total time to about four years and ten months. During the extension, participants will receive either CagriSema or cagrilintide. Throughout your time in the study, you'll have support from the study team, and you can ask them any questions you have.
Potential risks and benefits
Locations (119)
- Neighborhood HealthcareVerified postcodeEscondido, United States· Not yet recruiting
- Encore Medical Research LLCVerified postcodeHollywood, United States· Recruiting
- Jacksonville Ctr for Clin ResVerified postcodeJacksonville, United States· Not yet recruiting
- Encore Medical Research of WestonVerified postcodeWeston, United States· Recruiting
- Children's Healthcare AtlantaVerified postcodeAtlanta, United States· Recruiting
- Columbus Research FoundationVerified postcodeColumbus, United States· Recruiting
- Accel Research Sites-NeuroStudiesVerified postcodeDecatur, United States· Recruiting
- Eastside Bariatric and Gen SurgVerified postcodeSnellville, United States· Recruiting
- Solaris Clinical ResearchVerified postcodeMeridian, United States· Not yet recruiting
- IU Health - Riley Physicians Endo-DiabVerified postcodeIndianapolis, United States· Recruiting
- Cotton O'Neil Clinical Research CenterVerified postcodeTopeka, United States· Not yet recruiting
- Pennington Biomed Res CtrVerified postcodeBaton Rouge, United States· Recruiting
Common questions
What is CagriSema and cagrilintide?
These are new medicines being tested to see if they can help children and teenagers who are overweight to lose weight.
What is a 'placebo'?
A placebo is a dummy treatment that looks like the active study medicine but doesn't contain any real drug. It helps researchers know if the new medicine is actually working.
How long will I be in the study?
The first part of the study lasts about 1 year and 6 months. Some people can then choose to continue in an extension study, making the total time up to nearly 5 years.
Will I know which treatment I'm getting?
No, you won't know if you're getting the new medicine, semaglutide, or the placebo. This is to ensure the study results are fair and unbiased.
What happens if I have side effects?
The study team will closely monitor you for any side effects. If you experience any, you should tell the study staff immediately so they can provide help and advice.
How to find out more
Novo Nordisk
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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