NCT07282613

A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 Diabetes

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. Once Weekly Versus Placebo in Children and Adolescents With Type 2 Diabetes

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this clinical study is to look into how well a study medicine called CagriSema helps children and adolescents living with diabetes lower their blood sugar and body weight. The study has 2 parts: in the first part participant will get either CagriSema or placebo, and in the second part participant will get CagriSema. In the first part, which treatment participant gets is decided by chance and second part is open label and all participants will get CagriSema during this part. The study will last for about 1 year and 3 months.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	CagriSema (Cagrilintide B and Semaglutide I)	Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
DRUG	Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)	Placebo matched to Cagrilintide B and Placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector.

Timeline

• Start date: 2026-08-04
• Primary completion: 2029-09-07
• Completion: 2030-03-30
• First posted: 2025-12-15
• Last updated: 2026-03-30

Locations

55 sites across 10 countries: United States, Argentina, Brazil, Colombia, India, Israel, Malaysia, Mexico, Taiwan, Thailand

Regulatory

• FDA-regulated drug study