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

What Was Tested

This registered phase 3 trial tested Cagrilintide and Semaglutide.

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.

It had three arms (groups): Part 1: CagriSema (experimental), Part 1: Placebo (placebo comparator) and Part 2: CagriSema (experimental).

Participants will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 1.

Participants will receive placebo matched to CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 1.

Participants who received placebo in Part 1 will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 2.

The registry classes the interventions as drug.

Who Took Part

The registry lists 80 planned participants were the target.

It was open to people of any sex aged from 10 years up to 18 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Age 10 to \< 18 years at the time of signing the informed consent. Diagnosed with T2D (according to the latest International Society for Pediatric and Adolescent Diabetes \[ISPAD\] criteria) ≥ 30 days before screening.

The full record lists 14 inclusion and 8 exclusion criteria; among the exclusions: treatment with any antidiabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening; known or previous diagnosis of hypoparathyroidism; positive insulinoma associated-protein 2 (ia-2) antibodies or anti-glutamic acid decarboxylase (anti-gad) antibodies as determined by central laboratory at screening or in medical history.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Cagrilintide group and the comparison group should start out alike.

The Cagrilintide group and the comparison group ran side by side rather than switching.

As a double-blind Cagrilintide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-08-04 with completion listed for 2029-09-07.

It ran at 58 sites in United States (21), India (9), Brazil (6), Argentina (5), Israel (5) and Mexico (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in glycated haemoglobin (HbA1c) (time frame: From baseline (week 0) to end of double-blinded treatment (week 26)).

It also tracked 52 secondary outcomes, for example Relative change in body mass index (BMI), Change in mean sensor glucose concentration measured by CGM, CGM: Within-day glycaemic variability (% coefficient of variation), Number of participants with incidence of glycaemic rescue therapy, Change in fasting plasma glucose and Relative change in body weight.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cagrilintide and Semaglutide in 80 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cagrilintide compound page and the Semaglutide compound page, all human trials.