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Cagrilintide

AM-833, Long-acting amylin analogue

Quick Stats
Studies 57
Trials 38
Not Yet Recruiting PHASE3 INTERVENTIONAL NCT07253285

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

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

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.

Interventions

Name: Cagrilintide
Type: DRUG
Description: Participants will receive cagrilintide subcutaneously.
Name: Semaglutide
Type: DRUG
Description: Participants will receive semaglutide subcutaneously.
Name: Placebo cagrilintide
Type: DRUG
Description: Participants will receive placebo matched to cagrilintide subcutaneously.
Name: Placebo semaglutide
Type: DRUG
Description: Participants will receive placebo matched to semaglutide subcutaneously.

Primary Outcomes

Measure: Relative change in body mass index (BMI)
TimeFrame: Baseline (week 0), week 68
Description: Measured in percentage (%).

Trial Information

NCT ID

NCT07253285

Status

Not Yet Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

Novo Nordisk A/S

Last Updated

December 15, 2025