MedTrace Logo

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

NCT07253285 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2026-04-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Cagrilintide

Participants will receive cagrilintide subcutaneously.

DRUG

Semaglutide

Participants will receive semaglutide subcutaneously.

DRUG

Placebo cagrilintide

Participants will receive placebo matched to cagrilintide subcutaneously.

DRUG

Placebo semaglutide

Participants will receive placebo matched to semaglutide subcutaneously.

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency (dept. 2834) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-08
Primary Completion
2030-03-20
Completion
2033-09-20
FDA Drug
Yes

Countries

  • United States
  • 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

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07253285 on ClinicalTrials.gov