What is this study on Cagrilintide and CagriSema trying to find out about overweight and obesity in children and adolescents?

This study is evaluating how well the drugs CagriSema, cagrilintide, and semaglutide help children and adolescents with excess body weight lose weight. Researchers want to compare these new treatments against a placebo to understand their effects on weight management. The trial is sponsored by Novo Nordisk A/S and focuses on young people aged 8 to under 18 years.

Who may be eligible for this overweight and obesity clinical trial?

Children and adolescents aged 8 to under 18 years with excess body weight, meeting specific body mass index (BMI) criteria, may be eligible. Both males and females can participate. Participants should have tried diet and exercise programs without enough weight loss and meet certain health requirements. Please review eligibility criteria for more details.

Is there any cost to participate in this overweight and obesity clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants can expect to attend regular study visits and assessments without paying for the treatments.

Actively Recruiting

Phase 3

Age: 8Years - 18Years

All Genders

ID07253285

Efficacy, Safety and Pharmacokinetics of Cagrilintide and Semaglutide CagriSema Once Weekly for Weight Management in Children and Adolescents With Overweight or Obesity

Led by Novo Nordisk A/S · Updated on 2026-04-02

460

Participants Needed

119

Research Sites

182 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of CagriSema, cagrilintide, and semaglutide on weight loss in children and adolescents with excess body weight. This phase 3 study aims to compare these treatments against a placebo to see how well they help manage overweight or obesity in this younger population. The study is sponsored by Novo Nordisk AS and involves participants aged 8 to under 18 years who meet specific BMI and health criteria. Participants are randomly assigned to receive one of four treatments CagriSema a combination of cagrilintide and semaglutide, cagrilintide alone, semaglutide alone, or a placebo. All treatments are given as once-weekly injections under the skin, starting with a dose escalation period of up to 16 weeks, followed by maintenance dosing for 52 weeks in the main study. Those in the extension study continue with CagriSema or cagrilintide for up to 156 weeks, while participants who received semaglutide do not enter the extension phase. During the study, participants will have their body mass index BMI and body weight monitored regularly, with the primary outcome measured as the relative change in BMI from the start to week 68. Additional assessments include changes in body composition through scans like DXA and MRI, metabolic markers, blood pressure, and quality of life questionnaires. Safety is closely monitored throughout, with the total participation lasting about 1 year and 6 months for the main study and up to nearly 5 years if including the extension phase.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 8Years - 18Years

All Genders

Eligibility Criteria

You may qualify if you...

Parent(s) or legal representative must give informed consent and child must give assent before any study activities.
Male or female participants aged 8 to less than 18 years at consent.
BMI at screening at or above the 95th percentile for children aged 8 to under 12 years.
For adolescents aged 12 to under 18 years, BMI at or above the 95th percentile, or at least the 85th percentile with at least one obesity-related complication such as type 2 diabetes, hypertension, dyslipidaemia, or obstructive sleep apnea.
Laboratory tests within normal sex- and age-specific ranges for calcium, phosphate, alkaline phosphatase, and parathyroid hormone.
History of at least one unsuccessful attempt to lose weight with a structured diet and exercise program lasting at least 3 months.
Body weight greater than 45 kilograms at screening.
For participants with type 2 diabetes, HbA1c less than or equal to 10.0%, stable treatment with lifestyle intervention or metformin for at least 56 days before screening.

You will not qualify if you...

Use of any medication prescribed for obesity or weight management within 90 days before screening.
Previous or planned obesity surgery or weight loss device during the study, except certain procedures performed over 1 year before screening.
Uncontrolled thyroid disease.
Endocrine, hypothalamic, or syndromic obesity.
Body weight change greater than 5% within 90 days before screening.
Type 1 diabetes or monogenic diabetes.
For participants without type 2 diabetes, HbA1c greater than or equal to 6.5% or use of glucose-lowering agents within 90 days before screening.
For participants with type 2 diabetes, hypoglycaemic unawareness, recent severe hypoglycaemic episodes, certain diabetes-related antibodies, use of diabetes medications other than those allowed, or unstable diabetic retinopathy or maculopathy within 90 days before screening.

Research Team

Novo Nordisk

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