CagriSema for Type 2 Diabetes and Obesity
(REDEFINE 2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate how effectively the new medicine CagriSema (a combination of semaglutide and cagrilintide) aids weight loss in people with type 2 diabetes and obesity. Participants will receive either CagriSema or a placebo (a dummy medicine) to compare effects. The study will last about 1½ years to collect results. Individuals with type 2 diabetes, a BMI over 27, and stable diabetes medication for at least 90 days before the study may be suitable candidates. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial requires that your current diabetes medications remain stable for at least 90 days before joining. So, you should not stop taking them if you want to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that CagriSema, a combination of cagrilintide and semaglutide, has promising safety results from earlier studies. Patients using this combination have experienced significant weight loss with a good safety record. One study found that it led to a weight loss of up to 22.7% in adults without diabetes and 15.7% in those with type 2 diabetes.
Notably, cagrilintide causes less vomiting than semaglutide alone, which might make it easier for some patients to tolerate. These findings suggest that CagriSema is generally well-tolerated, with manageable side effects. The trial's later phase indicates that earlier stages thoroughly checked the treatment's safety.12345Why do researchers think this study treatment might be promising for type 2 diabetes and obesity?
Researchers are excited about CagriSema because it combines two active ingredients, cagrilintide and semaglutide, that target both type 2 diabetes and obesity. Unlike current treatments like metformin or insulin that primarily focus on controlling blood sugar, CagriSema addresses weight management as well, which is a significant concern for many patients with type 2 diabetes. Cagrilintide is a novel amylin analogue that helps control appetite, while semaglutide is a GLP-1 receptor agonist that enhances insulin secretion and reduces appetite. This combination could offer a more comprehensive approach to managing both blood sugar levels and weight, providing potential benefits that aren't achieved with many existing therapies.
What evidence suggests that this trial's treatments could be effective for type 2 diabetes and obesity?
Research has shown that CagriSema, a combination of cagrilintide and semaglutide, aids weight loss in individuals with type 2 diabetes and obesity. In some studies, participants lost up to 15.7% of their body weight with this treatment. CagriSema also helps control blood sugar levels in those with type 2 diabetes. One study found that CagriSema led to more weight loss than using either cagrilintide or semaglutide alone. In this trial, participants will receive either the CagriSema combination or a placebo. Overall, these findings suggest that CagriSema could be a promising option for managing weight and blood sugar in people with type 2 diabetes.12467
Who Is on the Research Team?
Clinical Transparency (dept. 2834)
Principal Investigator
Novo Nordisk A/S
Are You a Good Fit for This Trial?
Adults with type 2 diabetes and a BMI of at least 27.0 kg/m^2 can join this study if they've been on stable oral diabetic medication for the past 90 days and have an HbA1c level between 7%-10%. They shouldn't be pregnant, breastfeeding, or planning pregnancy during the trial. People with severe kidney issues, recent serious hypoglycemia, or unstable diabetic eye problems cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive CagriSema or placebo once weekly for weight loss and diabetes management
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cagrilintide
- Placebo cagrilintide
- Placebo semaglutide
- Semaglutide
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novo Nordisk A/S
Lead Sponsor
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