NCT07253285

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

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 Chidren and Adolescents With Overweight or Obesity

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 460 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Overweight
• Obesity

Interventions

Type	Name	Description
DRUG	Cagrilintide	Participants will receive cagrilintide subcutaneously.
DRUG	Semaglutide	Participants will receive semaglutide subcutaneously.
DRUG	Placebo cagrilintide	Participants will receive placebo matched to cagrilintide subcutaneously.
DRUG	Placebo semaglutide	Participants will receive placebo matched to semaglutide subcutaneously.

Timeline

• Start date: 2026-01-08
• Primary completion: 2030-03-20
• Completion: 2033-09-20
• First posted: 2025-11-28
• Last updated: 2026-04-02

Locations

119 sites across 26 countries: United States, Australia, Austria, Belgium, Bulgaria, China, Colombia, Croatia, Denmark, Hungary, India, Israel, Italy, Malaysia, Mexico, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, Sweden, Taiwan, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study