Cagrilintide + CagriSema for Childhood Obesity

Not yet recruiting at 96 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Novo Nordisk A/S

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of 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 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.

Who Is on the Research Team?

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This trial is for children and adolescents carrying excess body weight. Participants will be randomly assigned to receive either a new study drug called CagriSema, another new drug named cagrilintide, an already-prescribed medication semaglutide, or a placebo with no active ingredients.

Inclusion Criteria

Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent obtained before any study related activities

Parent(s) or LAR of the child must sign and date the Informed Consent Form according to local requirements

Child must sign and date the Child Assent Form or provide oral assent according to local requirements

Exclusion Criteria

Endocrine, hypothalamic, or syndromic obesity

My thyroid condition is not under control.

I have not taken obesity or weight management medication in the last 90 days.

What Are the Treatments Tested in This Trial?

Interventions

• Cagrilintide
• Semaglutide

Trial Overview The effectiveness of two new drugs, CagriSema and cagrilintide, in helping young individuals lose weight is being tested against semaglutide (an existing treatment) and placebo. The main study lasts about 1.5 years with an optional extension phase totaling nearly 5 years.

How Is the Trial Designed?

Group I: Semaglutide Experimental Treatment 2 Interventions

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.

Group II: Cagrilintide Experimental Treatment 2 Interventions

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.

Group III: CagriSema Experimental Treatment 4 Interventions

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.

Group IV: Placebo Placebo Group 2 Interventions

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.

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen