Cagrilintide or CagriSema for Kids with Excess Weight

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

Recruiting Phase 3 Interventional Study
Overweight Obesity
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
8 – 18
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
460 (estimated)
Sponsor
Novo Nordisk A/S · Industry
Who this trial is looking for

This trial is looking for children and teens aged 8 to 17 who have excess body weight. Participants will receive either a new drug or a placebo and will be followed for up to 4 years. There may be side effects from the treatments.

Are You a Good Fit for This Trial?
Must be taking Metformin
Rules you out Type 1 diabetesUncontrolled diabetic retinopathy

You may be able to join if

  • I am aged 8 to under 18 years old.
  • I have a body mass index (BMI) in the 95th percentile or higher for my age.
  • I weigh more than 45 kilograms.
  • I have tried to lose weight through diet and exercise for at least 3 months.
  • My parent or legal guardian has given permission for me to participate.

You may not be able to join if

  • I have taken any weight management medication in the last 90 days.
  • I have had weight loss surgery or used a weight loss device recently.
  • I have uncontrolled thyroid disease.
  • I have a history of significant weight change recently.
  • I have type 1 diabetes or certain other types of diabetes.
  • I have had severe low blood sugar episodes recently.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 lik…
Trial Locations
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Eligibility Criteria
Inclusion criteria: * Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study related activities. Study related activities are any procedures that are carried out as part of the study, including activiti…
Contacts

Novo Nordisk

(+1) 866-867-7178

clinicaltrials@novonordisk.com

CONTACT