Cagrilintide + CagriSema for Childhood Obesity

Not yet recruiting at 106 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Novo Nordisk A/S

Must be taking: Metformin

Must not be taking: Obesity medications, Diabetes medications

Disqualifiers: Type 1 diabetes, Uncontrolled thyroid, others

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

Duration: 68 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how well two new drugs, CagriSema and cagrilintide, assist children and teens with excess body weight in losing weight. Participants will receive either CagriSema, cagrilintide, semaglutide (an existing weight-loss drug), or a placebo (a substance with no active ingredients). Those who benefit from semaglutide will not continue in the extension phase, but others may receive CagriSema or cagrilintide for a longer period. Children aged 8 to under 18 who are significantly overweight and have unsuccessfully tried to lose weight through diet and exercise might be a good fit for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking weight-loss treatments.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking any medication for obesity or weight management, you must stop at least 90 days before screening. If you have type 2 diabetes and are taking metformin, you should continue with a stable dose for at least 56 days before screening.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that CagriSema and cagrilintide have promising safety results in clinical studies. One study found that CagriSema helped adults lose a significant amount of weight, with fewer side effects like vomiting compared to other treatments. Cagrilintide alone also led to meaningful weight loss and was well-tolerated, with safety results similar to current treatments.

For semaglutide, studies have shown it is already used for weight management in teens and adults. It effectively reduces body weight and is generally well-tolerated. Most side effects are mild, such as nausea.

Overall, the treatments tested in this trial—CagriSema, cagrilintide, and semaglutide—have shown favorable safety in previous studies. Participants experienced manageable side effects, suggesting these treatments are generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about CagriSema for childhood obesity because it combines two active ingredients, cagrilintide and semaglutide, which work together to regulate appetite and metabolic processes. Unlike typical treatments that focus solely on lifestyle changes or single drugs, CagriSema offers a novel approach with its dual-action mechanism. Additionally, this combination is administered as a once-weekly injection, which could improve adherence compared to daily oral medications.

What evidence suggests that this trial's treatments could be effective for childhood obesity?

Research has shown that CagriSema, a treatment in this trial, can help people lose a significant amount of weight. In studies, adults with obesity lost up to 22.7% of their body weight using CagriSema. This surpasses the 16.1% weight loss observed with semaglutide alone, another treatment option in this trial. Cagrilintide alone, also under study, aided in weight loss but not as effectively as the combination in CagriSema. These findings suggest that CagriSema could be a strong option for weight loss in children and teenagers with obesity. ^{1 3 6 7 8}

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a once weekly subcutaneous dose of CagriSema, cagrilintide, semaglutide, or placebo in a dose escalation regimen for up to 16 weeks, followed by maintenance for 52 weeks

68 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may continue to receive CagriSema or cagrilintide for up to 156 weeks

156 weeks

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

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07253285

A Research Study on How Well Cagrilintide and ...

This study will look at how well CagriSema and cagrilintide help children and adolescents with excess body weight lose weight.

2.

diabetes.org

diabetes.org/newsroom/press-releases/cagrisema-demonstrates-significant-weight-loss-adults-obesity

CagriSema Demonstrates Significant Weight Loss in Adults ...

Once-weekly medication results in weight loss of up to 22.7% in adults without diabetes and 15.7% in those with type 2 diabetes.

3.

rheumatologyadvisor.com

rheumatologyadvisor.com/news/redefine-1-trial-superior-weight-loss-seen-with-cagrisema/

REDEFINE 1 Trial: Superior Weight Loss Seen With ...

CagriSema-treated patients achieved a superior weight loss of 22.7% compared with 11.8% with cagrilintide 2.4mg, 16.1% with semaglutide 2.4mg and 2.3% with ...

4.

healio.com

healio.com/news/endocrinology/20241223/adults-with-obesity-lost-227-of-body-weight-with-combination-glp1amylin-analog

Adults with obesity lost 22.7% of body weight ...

In the trial product estimand, adults receiving CagriSema achieved a 22.7% weight loss at 68 weeks compared with a 16.1% weight reduction with ...

5.

gastroenterologyadvisor.com

gastroenterologyadvisor.com/news/cagrisema-elicits-significant-weight-loss-in-obesity-with-or-without-t2d/

CagriSema Elicits Significant Weight Loss in Obesity With ...

At week 68, participants in REDEFINE 1 had lost a mean 20.4% of their body weight with CagriSema vs 14.9% with semaglutide, 11.5% with ...

6.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2502081

Coadministered Cagrilintide and Semaglutide in Adults ...

In a phase 2 trial, cagrilintide at a dose of 2.4 mg led to a 9.7% weight reduction by week 26. Because the combination of therapies with ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39676787/

Efficacy and Safety of Cagrilintide Alone and in ...

Cagrisema outperforms semaglutide regarding weight loss. Cagrilintide shows comparable weight loss to semaglutide/liraglutide with significantly lower vomiting.

8.

journals.lww.com

journals.lww.com/indjem/fulltext/2024/09000/efficacy_and_safety_of_cagrilintide_alone_and_in.2.aspx

Efficacy and Safety of Cagrilintide Alone and in...

Cagrisema outperforms semaglutide regarding weight loss. Cagrilintide shows comparable weight loss to semaglutide/liraglutide with significantly lower vomiting.