At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Cagrilintide (drug), Semaglutide (drug), Placebo cagrilintide (drug), Placebo semaglutide (drug)
- How long the study runs
- Study runs about 92 months (dates as stated)
- About the drug or intervention
- Cagrilintide — drug: Participants will receive cagrilintide subcutaneously. · Semaglutide — drug: Participants will receive semaglutide subcutaneously. · Placebo cagrilintide — drug: Participants will receive placebo matched to cagrilintide subcutaneously. · Placebo semaglutide — drug: Participants will receive placebo matched to semaglutide subcutaneously.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 8 Years to 18 Years
- Who
- All
- Number of participants
- 460
- Started
- 2026-01-08
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for overweight
- • Phase3 - 460 participants
- • This study will look at how well CagriSema and cagrilintide help children and adolescents with excess body weight lose weight
Who can take part?
- • Ages 8 Years to 18 Years
- • Diagnosed with overweight
Where?
- • Birmingham - Birmingham Children's Hospital
- • Liverpool - Alder Hey Children's Hospital
- • London - University College Hospital - Paediatric Services
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 8 Years - 18 Years
- Who can join: All genders
What the study is looking for
- ✓The parent(s) or LAR of the child must sign and date the agreement to take part Form (according to local requirements)
- ✓The child must sign and date the Child Assent Form or provide oral assent (according to local requirements).
- ✓Male or female.
- ✓Aged 8 to less than (\<) 18 years at the time of signing the agreement to take part.
- ✓Body mass index (BMI), at screening, corresponding to:
Who cannot take part
- ✗Treatment with any medication prescribed for obesity or weight management within 90 days before screening.
- ✗Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the...
- ✗Liposuction and/or abdominoplasty, if performed \> 1 year before screening.
- ✗Adjustable gastric banding, if the band has been removed \> 1 year before screening.
- ✗Intragastric balloon, if the balloon has been removed \> 1 year before screening.
See the full criteria
Where Is This Study? (3 UK sites)
Birmingham Children's Hospital
Birmingham B4 6NH, United Kingdom
Alder Hey Children's Hospital
Liverpool L12 2AP, United Kingdom
University College Hospital - Paediatric Services
London NW1 1BU, United Kingdom
How to Get in Touch
Novo Nordisk
Sponsor contactCONTACT
