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

NCT07253285 · Recruiting

Last updated 2026-05-28

This study is testing how well the medications cagrilintide and CagriSema work to reduce excess body weight in children and adolescents.

Status Recruiting Currently enrolling participants.

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

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 460 people Planned (estimated).

Who can join Ages 8–18 · all sexes

Timeline Started 2026-01 · est. completion 2033-09

Where 119 sites · 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, United States

What this study is testing ClinicalTrials.gov NCT07253285 ↗

Description as written by the study sponsor.

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.

Treatments tested

Cagrilintide Drug

Participants will receive cagrilintide subcutaneously.
Semaglutide Drug

Participants will receive semaglutide subcutaneously.
Placebo cagrilintide Drug

Participants will receive placebo matched to cagrilintide subcutaneously.
Placebo semaglutide Drug

Participants will receive placebo matched to semaglutide subcutaneously.

Main thing measured	Relative change in body mass index (BMI)
Sponsor	Novo Nordisk A/S
Conditions studied	Overweight, Obesity
GLP-1 drugs	cagrilintide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07253285 ↗