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

NCT07282613 · Not yet recruiting

Last updated 2026-05-28

This study is testing how the medication CagriSema affects blood sugar and body weight in children and adolescents with type 2 diabetes compared to a placebo.

Status Not yet recruiting Approved but enrollment has not started.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 80 people Planned (estimated).

Who can join Ages 10–18 · all sexes

Timeline Started 2026-08 · est. completion 2030-03

Where 55 sites · Argentina, Brazil, Colombia, India, Israel, Malaysia, Mexico, Taiwan, Thailand, United States

What this study is testing ClinicalTrials.gov NCT07282613 ↗

Description as written by the study sponsor.

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.

Treatments tested

CagriSema (Cagrilintide B and Semaglutide I) Drug

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

Placebo matched to Cagrilintide B and Placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector.

Main thing measured	Change in glycated haemoglobin (HbA1c)
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes Mellitus, Type 2
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07282613 ↗