RecruitingOverweightObesity

A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight

Eligible age

8–18 yrs

Accepts

All genders

Locations

19 states

Healthy volunteers

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About 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. 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.

Sponsor: Novo Nordisk A/S

You may qualify if…

✓ Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
✓ The parent(s) or LAR of the child must sign and date the Informed Consent 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 informed consent.
✓ Body mass index (BMI), at screening, corresponding to:
✓ Greater than or equal to (\>=) 95th percentile for children aged 8 to \< 12 years (Tanner stage 1-5)
✓ \>= 95th percentile or \>= 85th percentile with the presence of at least one obesity-related complication including, but not limited to, type 2 diabetes (T2D), hypertension, dyslipidaemia or obstructive sleep apnoea for adolescents aged 12 to \< 18 years (Tanner stage 2-5).