A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
Recruiting · 40 sites across 22 states
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Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
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Your choice
Voluntary — you can stop anytime
What is this study?
This study will look at how well CagriSema and cagrilintide help children and adolescents with excess body weight lose weight. The study has 2 parts: main and extension study.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
This study will look at how well CagriSema and cagrilintide help children and adolescents with excess body weight lose weight. The study has 2 parts: main and extension study. In the main study, participants will either get CagriSema (a new study drug), cagrilintide (a new study drug), semaglutide (a drug that doctors can already prescribe to adolescents and adults) or placebo (a placebo looks like the treatment being tested, but doesn't have any active ingredients in it). Which treatment participants will get is decided by chance. Participants who get semaglutide in the main study will not take part in the extension study. If participants take part in the extension study, they will get either CagriSema or cagrilintide in this part of the study. Like all drugs, the study drugs may have side effects. The total time participants will be in the main study is about 1 year and 6 months. If participants take part in the extension study, the total time is about 4 years and 10 months.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Children or teens age 8 to under 18 who have excess body weight based on BMI percentiles at screening.
- •Children/teens whose parent or legal representative can give consent and the child can give assent (as age-appropriate).
- •Children/teens with a history of at least one unsuccessful attempt to lose enough weight after 3+ months of diet and exercise counseling.
- •Participants must weigh more than 45 kg at screening.
- •For children with type 2 diabetes (T2D): HbA1c must be 10.0% or lower and diabetes treatment must be stable as specified in the study.
🚫 You may not be able to join if…
- •Anyone who has used a weight-loss or obesity medicine within 90 days before screening.
- •Anyone who has had (or plans) obesity surgery or a weight-loss device during the study period (with some older exceptions listed, like certain procedures done more than 1 year before screening).
- •Anyone with uncontrolled thyroid disease, or endocrine/hypothalamic/syndromic obesity.
- •Anyone with type 1 diabetes or monogenic diabetes.
- •For some participants (especially those with T2D): people with certain diabetes complications or unstable eye problems are not allowed.
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 8–18
- ✓Have Obesity / overweight or Type 2 diabetes or High blood pressure
- !Some conditions may not be a fit: Anxiety
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
What you need to know before you apply
What is this study testing?+
This study will look at how well CagriSema and cagrilintide help children and adolescents with excess body weight lose weight. The study has 2 parts: main and extension study.
Is it safe? Who makes sure of that?+
This is a late-stage study (Phase 3), testing how well the treatment works in more people. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.
Source: ClinicalTrials.gov · NCT07253285 · Locations: California · Florida · Georgia · Idaho · Indiana · Kansas · Louisiana · Maryland · Minnesota · New York · North Dakota · Ohio · Oklahoma · Pennsylvania · South Carolina · South Dakota · Tennessee · Texas · Utah · New South Wales · Queensland · Western Australia