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

What Was Tested

The trial (phase 3) is built around Cagrilintide and Semaglutide.

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).

It had four arms (groups): CagriSema (experimental), Semaglutide (experimental), Cagrilintide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 460 planned participants were the target.

It was open to people of any sex aged from 8 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. Aged 8 to less than (\<) 18 years at the time of signing the informed consent. Body mass index (BMI), at screening, corresponding to:.

The full record lists 14 inclusion and 17 exclusion criteria; among the exclusions: treatment with any medication prescribed for obesity or weight management within 90 days before screening; previous or planned (during the study period) obesity treatment with surgery or a weight loss device. however, the following are allowed:; liposuction and/or abdominoplasty, if performed \> 1 year before screening.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Cagrilintide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Cagrilintide, so expectations could not easily colour the readings.

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

It started in 2026-01-08 with completion listed for 2030-03-20.

It ran at 121 sites in United States (34), China (9), India (9), Bulgaria (4), Israel (4) and Italy (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Relative change in body mass index (BMI) (time frame: Baseline (week 0), week 68).

It also tracked 73 secondary outcomes, for example Relative change in body weight, Change in BMI Standard Deviation Score (SDS), Relative change in BMI, Number of participants who achieved normal BMI, Number of participants who shifted from obese to non-obese BMI class and Change in waist circumference.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cagrilintide and Semaglutide in 460 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.