Efficacy, safety and pharmacokinetics of cagrilintide s.c. 2.4 mg as monotherapy and in combination with semaglutide s.c. 2.4 mg (CagriSema) once weekly for weight management in children and adolescents with overweight or obesity

Status

Not yet recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509176-42-00

Enrollment

Registered

2026-04-28

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity and T2D

Brief summary

Relative change in body mass index (BMI). Baseline (week 0) to end of treatment (week 68). Unit: %.

Detailed description

Relative change in body weight. Baseline (week 0) to end of treatment (week 68). Unit: %., Change in BMI Standard Deviation Score (SDS). Baseline (week 0) to end of treatment (week 68). Unit: SDS score, Relative change in BMI. Baseline (week 0) to end of treatment (week 68). Unit: %., Relative change in body weight. Baseline (week 0) to end of treatment (week 68). Unit: %., Change in BMI Standard Deviation Score (SDS). Baseline (week 0) to end of treatment (week 68). Unit: SDS score., Reduction in weight category. Baseline (week 0) to end of treatment (week 68). Unit: count of participant., Reduction in weight category. Baseline (week 0) to end of treatment (week 68). Unit: count of participant.

Interventions

DRUGcagrilintide

DRUGPlacebo + Placebo

DRUGsemaglutide

DRUGcagrilintide semaglutide

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Relative change in body mass index (BMI). Baseline (week 0) to end of treatment (week 68). Unit: %.	—

Secondary

Measure	Time frame
Relative change in body weight. Baseline (week 0) to end of treatment (week 68). Unit: %., Change in BMI Standard Deviation Score (SDS). Baseline (week 0) to end of treatment (week 68). Unit: SDS score, Relative change in BMI. Baseline (week 0) to end of treatment (week 68). Unit: %., Relative change in body weight. Baseline (week 0) to end of treatment (week 68). Unit: %., Change in BMI Standard Deviation Score (SDS). Baseline (week 0) to end of treatment (week 68). Unit: SDS score., Reduction in weight category. Baseline (week 0) to end of treatment (week 68). Unit: count of participant., Reduction in weight category. Baseline (week 0) to end of treatment (week 68). Unit: count of participant.	—

Measure

Time frame

—

Outcome results

None listed

Source: EU CTIS · Data processed: Apr 30, 2026