CagriSema for Type 2 Diabetes

(REIMAGINEYOUNG Trial)

Not yet recruiting at 48 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Novo Nordisk A/S

Must be taking: Insulin, Metformin, SGLT2i

Must not be taking: Anti-obesity medications

Disqualifiers: Pregnancy, Hypoparathyroidism, Severe hypoglycemia, 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well a new medicine, CagriSema, helps children and teens with type 2 diabetes manage their blood sugar and weight. Initially, participants will receive either CagriSema or a placebo (a substance with no active drug), followed by CagriSema for all. The trial seeks children and teens diagnosed with type 2 diabetes for at least 30 days who are managing it with diet, exercise, or certain other medications. As a Phase 3 trial, this is the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

You can continue taking your current diabetes medications like insulin, metformin, or SGLT2 inhibitors as long as the dose has been stable for a certain period before the study. However, you cannot take any other diabetes or weight-loss medications within 90 days before starting the trial.

Is there any evidence suggesting that CagriSema is likely to be safe for humans?

Research has shown that CagriSema, a combination of cagrilintide and semaglutide, is generally safe and well-tolerated. Earlier studies reported no life-threatening side effects, indicating likely safety. Participants experienced significant benefits, such as weight loss and improved blood sugar control, without major safety concerns. Some mild side effects occurred but were not serious. This treatment is in advanced trials, demonstrating reasonable safety in earlier research. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for diabetes?

CagriSema is unique because it combines two active ingredients, Cagrilintide B and Semaglutide I, which work together to manage Type 2 Diabetes more effectively. Most current treatments focus on improving insulin sensitivity or increasing insulin production, but CagriSema targets both appetite regulation and blood sugar control. This dual-action approach not only helps with glycemic control but also supports weight management, a crucial aspect for many with Type 2 Diabetes. Researchers are excited about its potential to address multiple challenges faced by patients with just one treatment.

What evidence suggests that CagriSema might be an effective treatment for Type 2 Diabetes?

Research has shown that CagriSema, a combination of cagrilintide and semaglutide, can lower blood sugar and aid in weight loss. In earlier studies, adults with type 2 diabetes using this treatment lost up to 15.7% of their body weight. Additionally, semaglutide alone has improved kidney health in people with type 2 diabetes. In this trial, participants will receive either CagriSema or a placebo to evaluate its effectiveness. These findings suggest that CagriSema might also help young people with diabetes manage their blood sugar and weight. ^{1 3 5 6 7}

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 with Type 2 Diabetes. Participants will be randomly chosen to receive either the study medication CagriSema or a placebo during the first part of the study, and all participants will receive CagriSema in the second part.

Inclusion Criteria

I manage my condition with diet, exercise, and possibly insulin, metformin, or SGLT2i.

I was diagnosed with type 2 diabetes more than 30 days ago.

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

Exclusion Criteria

I am not pregnant, breastfeeding, planning to become pregnant, or if of childbearing potential, I am using effective contraception.

Known hypoglycaemic unawareness as indicated by the investigator

I haven't taken any diabetes or weight loss drugs not listed in the criteria 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 Part 1

Participants receive either CagriSema or placebo subcutaneously once weekly

26 weeks

Weekly visits (in-person)

Treatment Part 2

All participants receive CagriSema subcutaneously once weekly in an open-label manner

26 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CagriSema

Trial Overview

The trial is testing how effective CagriSema (a combination of Cagrilintide B and Semaglutide I) is at lowering blood sugar levels and body weight compared to a placebo. The study has two parts: a randomized phase followed by an open-label phase where everyone gets the drug.

How Is the Trial Designed?

Group I: Part 2: CagriSema Experimental Treatment 1 Intervention

Participants who received placebo in Part 1 will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 2.

Group II: Part 1: CagriSema Experimental Treatment 1 Intervention

Participants will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 1.

Group III: Part 1: Placebo Placebo Group 1 Intervention

Participants will receive placebo matched to CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 1.

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.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2502081

Coadministered Cagrilintide & Semaglutide for Obesity

In a phase 2 trial, cagrilintide at a dose of 2.4 mg led to a 9.7% weight reduction by week 26. ... We now provide the efficacy and safety results ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40544432/

Cagrilintide-Semaglutide in Adults with Overweight or ...

Once-weekly cagrilintide-semaglutide (at a dose of 2.4 mg each) resulted in a significantly lower body weight than placebo in adults with obesity and type 2 ...

3.

ahajournals.org

ahajournals.org/doi/10.1161/HYPERTENSIONAHA.125.26055

CagriSema Reduces Blood Pressure in Adults With ...

Semaglutide is also associated with considerable weight loss, beneficial effects on kidney outcomes in patients with type 2 diabetes, and a ...

4.

diabetes.org

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

CagriSema: Weight Loss in Adults with Obesity

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.

5.

mediacenteratypon.nejmgroup-production.org

mediacenteratypon.nejmgroup-production.org/NEJMoa2502082.pdf

Cagrilintide–Semaglutide in Adults with Overweight or Obesity ...

Cagrilintide and semaglutide have each been shown to induce weight loss as monotherapies. Data are needed on the coadministration of ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37364590/

Efficacy and safety of co-administered once-weekly ...

No fatal adverse events were reported. Interpretation: In people with type 2 diabetes, treatment with CagriSema resulted in clinically relevant ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S014067362100845X

Articles Safety, tolerability, pharmacokinetics, and ...

Concomitant treatment with cagrilintide and semaglutide 2·4 mg was well tolerated with an acceptable safety profile. Future larger and longer trials are needed ...