AuthorisedPhase III and phase IV (Integrated)Interventional

Efficacy, safety and pharmacokinetics of cagrilintide s.c. 2.4 mg as monotherapy and in combination with semaglutide s.c. 2.4 mg (CagriSema) once weekly for weight management in children and adolescents with overweight or obesity

This research is investigating new treatment options for children and teenagers who are overweight or have obesity. The study aims to understand how safe and effective a medicine called cagrilintide is, both when given alone and when combined with semaglutide. Both medicines are given as a weekly injection under the skin. Researchers will be looking at changes in body mass index (BMI) and body weight over 68 weeks. It's a Phase III and IV study, meaning it's in the later stages of testing new treatments, building on earlier research. The goal is to find better ways to help young people achieve and maintain a healthy weight.

At a glance

Status

Authorised

Phase

Phase III and phase IV (Integrated)

Sponsor

Novo Nordisk A/S

Enrolment target

157

Start

28 Apr 2026

Obesity and T2D

What is this study about?

This study is a research project focusing on new developments in helping children and teenagers who are overweight or have obesity. The main goal is to test a medicine called cagrilintide, which is given as a weekly injection just under the skin. Researchers want to understand two key things: first, how well cagrilintide works by itself to help with weight management, and second, how well it works when it’s combined with another medicine called semaglutide.

Over a period of 68 weeks, the study will carefully measure changes in participants' body mass index (BMI), which is a common way to see if someone is a healthy weight for their height. They will also look at changes in overall body weight and how these treatments affect a person's weight category. This research is important because it could lead to new and more effective ways to support young people in managing their weight, which can have many long-term health benefits.

This study is in its 'Phase III and IV' stages, which means it's a later stage of research. This indicates that these medicines have already undergone earlier testing and are now being studied in a larger group of people to confirm their benefits and safety, and to gather more information for potential use in the future. The findings from this kind of study are crucial for developing better treatments and care for young people with weight challenges.

Key takeaways

Tests new medicines for weight management in young people.
Compares cagrilintide alone and with semaglutide.
Study lasts for approximately 68 weeks.
Involves weekly injections and regular health checks.
Aims to improve treatment for overweight and obesity in children and teens.

Who may be eligible?

This study is looking for children and teenagers of any age who are overweight or have obesity. It's open to both boys and girls.

The researchers will also be looking for participants who may have Type 2 Diabetes (T2D) in addition to being overweight or having obesity. The team will provide more specific details about who can take part, as there will be certain health checks and criteria to ensure the study is safe and suitable for everyone involved.

If you or a young person you know fits this general description and is interested, the next step would be to speak with your doctor or the study team to find out if it's the right fit. They will be able to explain all the requirements in more detail.

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 a child or teenager?
Are you considered overweight or to have obesity?
Are you able to attend regular clinic visits for about 18 months?
Are you potentially diagnosed with Type 2 Diabetes, or are able to be screened for it?
Are you comfortable with weekly injections?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve regular visits to a clinic over a period of 68 weeks, which is about a year and a half. During these visits, the study team would check your health, take measurements like your weight and height to calculate your BMI, and monitor how you are feeling.

You would receive weekly injections of either the study medicine (cagrilintide, or cagrilintide combined with semaglutide), or a 'placebo', which looks like the medicine but contains no active drug. This is done to fairly compare the effects of the medicines. The injections are given just under the skin. There would be several assessments throughout the 68 weeks to track any changes in your weight, BMI, and overall health. The team would also keep a close eye on any side effects you might experience. The total duration of active treatment and follow-up for the study is 68 weeks.

Potential risks and benefits

Taking part in a study like this might offer potential benefits, such as receiving expert medical care and access to new treatments that aren't yet widely available. It could help you manage your weight and improve your health. However, as with any medicine, there could be potential side effects, which the study team will discuss with you. You might also receive a placebo, meaning you wouldn't get the active medicine. It's very important to remember that participating is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (14)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Slovakia
—
Unverified
Austria
—
Unverified
Spain
—
Unverified
Romania
—
Unverified
Portugal
—
Unverified
Italy
—
Unverified
Denmark
—
Unverified
Belgium
—
Unverified
Sweden
—
Unverified
Poland
—
Unverified
Netherlands
—
Unverified
Croatia

Common questions

What is BMI?

BMI stands for Body Mass Index. It's a measurement that uses your height and weight to estimate if you're a healthy weight, underweight, overweight, or have obesity. For children and teenagers, it's often looked at against charts for their age and sex.

What is a 'placebo'?

A placebo looks exactly like the study medicine, but it doesn't contain any active drug. Giving some participants a placebo helps researchers fairly compare the new medicine's effects against having no active treatment.

How long will the study last?

The study will last for a total of 68 weeks, which is about a year and a half.

What medicines are being tested?

The study is testing a medicine called cagrilintide, both on its own and in combination with another medicine called semaglutide. Some participants will also receive a placebo.

Why is this study important for young people?

This study is important because it could help find new and better ways to support children and teenagers in managing their weight, which can lead to better health now and in the future.