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

Conditions

• Obesity
• Overweight

Eligibility Criteria

Sex

ALL

Age

8 Years - 18 Years

Healthy Volunteers

Not accepted

Interventions

• Cagrilintide — DRUG
  Participants will receive cagrilintide subcutaneously.
• Semaglutide — DRUG
  Participants will receive semaglutide subcutaneously.
• Placebo cagrilintide — DRUG
  Participants will receive placebo matched to cagrilintide subcutaneously.
• Placebo semaglutide — DRUG
  Participants will receive placebo matched to semaglutide subcutaneously.

Study Details

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.

Key Dates

Start date

Jan 8, 2026

Status verified

Mar 2026

Primary completion

Mar 20, 2030

Completion

Sep 20, 2033

Study Design

Enrollment

460 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CagriSema
  Participants will receive once weekly subcutaneous (s.c.) dose of CagriSema (cagrilintide and semaglutide) in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks and further continue to receive the same dose or maximum tolerated dose (MTD) in the open-label extension phase for up to 156 weeks.
• Experimental: Semaglutide
  Participants will receive once weekly s.c. dose of semaglutide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks.
• Experimental: Cagrilintide
  Participants will receive once weekly s.c. dose of cagrilintide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks, further continue to receive the same dose as the dose escalation regimen or MTD in the open-label extension phase for up to 156 weeks.
• Placebo Comparator: Placebo
  Participants will receive once weekly s.c. dose of placebo matched to cagrilintide/semaglutide in a dose escalation regimen in the main phase for up to 16 weeks and maintained for 52 weeks. Participants will further continue to receive the same dose escalation regimen as CagriSema for 16 weeks, later continue to receive the same dose or MTD in the open-label extension phase for up to 140 weeks.

Primary Outcome Measure

Relative change in body mass index (BMI) [ Time Frame: Baseline (week 0), week 68 ]

Central Contacts

• Novo Nordisk
  (+1) 866-867-7178
  [email protected]

Locations (34)

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