Cagrilintide for Obesity and Type 2 Diabetes
(RENEW 2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new medicine, cagrilintide, to determine if it aids weight loss in people with obesity and type 2 diabetes. Participants will receive either cagrilintide or a placebo, with a higher likelihood of receiving the actual treatment. The trial seeks individuals with a body mass index (BMI) of 27 or higher, who have had type 2 diabetes for at least six months, and have struggled to lose weight through diet. Participants will engage in the study for about a year and a half. As a Phase 3 trial, this study is the final step before potential FDA approval, offering participants the opportunity to contribute to a treatment that could soon become widely available.
Will I have to stop taking my current medications?
You may need to stop certain medications if they are prescribed for weight management or are GLP-1 receptor agonists, unless you meet specific criteria. However, if you are on stable doses of certain diabetes medications, you may continue them during the trial.
Is there any evidence suggesting that cagrilintide is likely to be safe for humans?
Research has shown that cagrilintide is generally safe for individuals who are overweight or have obesity. In previous studies, it aided weight loss without causing serious side effects. Some participants experienced mild to moderate issues like nausea or vomiting, but these were uncommon, and most could continue the treatment. Researchers have also studied the body's handling of cagrilintide and found it safe for repeated use. Since this trial is in a late stage, substantial safety data suggests that cagrilintide is safe for most people. However, as with any treatment, reactions can vary from person to person.12345
Why do researchers think this study treatment might be promising?
Cagrilintide is unique because it introduces a new approach to managing obesity and Type 2 diabetes by mimicking a natural hormone involved in appetite regulation. Unlike traditional treatments that primarily focus on insulin regulation or appetite suppression through alternate pathways, cagrilintide works by targeting the amylin hormone pathway, which plays a significant role in reducing hunger and controlling food intake. Researchers are excited about cagrilintide because it is administered as a once-weekly injection, offering potential convenience and compliance benefits over daily medications. This innovative mechanism and delivery method could represent a promising advancement in the long-term management of these conditions.
What evidence suggests that cagrilintide might be an effective treatment for obesity and type 2 diabetes?
Research has shown that cagrilintide can aid in weight loss. One study found that participants using only cagrilintide lost 9.7% of their body weight in 26 weeks. This trial will test cagrilintide alone, with participants receiving it subcutaneously once weekly for 64 weeks. Another study discovered that combining cagrilintide with semaglutide resulted in weight loss of up to 15.7% in individuals with type 2 diabetes. These findings suggest that cagrilintide could be a promising treatment for managing obesity and type 2 diabetes.16789
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 adults with overweight or obesity who also have type 2 diabetes. Participants should not be currently prescribed cagrilintide and must commit to a study duration of about 1 year and 6 months.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive cagrilintide or placebo subcutaneously once weekly
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cagrilintide
Trial Overview
The study tests the effectiveness of cagrilintide in reducing body weight compared to a placebo. Participants have a higher chance (2:1) of receiving cagrilintide over the placebo, which is assigned randomly.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive cagrilintide subcutaneously once weekly for 64 weeks.
Participants will receive placebo matched to cagrilintide subcutaneously once weekly for 64 weeks.
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
Citations
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 ...
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 ...
3.
diabetes.org
diabetes.org/newsroom/press-releases/cagrisema-demonstrates-significant-weight-loss-adults-obesityCagriSema 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.
Efficacy and safety of co-administered once-weekly ...
This trial assessed the efficacy and safety of co-administered semaglutide with cagrilintide (CagriSema) in participants with type 2 diabetes.
5.
pharmacytimes.com
pharmacytimes.com/view/cagrilintide-demonstrates-promising-results-as-monotherapy-for-obesity-managementCagrilintide Demonstrates Promising Results as ...
Cagrilintide shows significant weight loss in adults with obesity, marking a breakthrough in obesity treatment with promising phase 3 trial ...
Efficacy and Safety of Cagrilintide Alone and in ...
At 26–32 weeks, cagrilintide 2.4 mg had a similar percentage reduction in body weight compared to liraglutide/semaglutide [MD − 1.83% (95% CI: − ...
7.
sciencehub.novonordisk.com
sciencehub.novonordisk.com/content/dam/sciencehub/global/en/congresses-and-scientific-publications/congresses/easd2025/garvey1/documents/Garvey_EASD25_REDEFINE_1_Cagrilintide_Short_oral_with_disclosures.pdfEfficacy and safety of cagrilintide 2.4 mg in adults with ...
In adults with overweight/obesity, without type 2 diabetes, treatment with the long- acting amylin analogue cagrilintide 2.4 mg led to a ...
Articles Safety, tolerability, pharmacokinetics, and ...
We aimed to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics (including weight change from baseline) of six multiple-ascending doses ...
Weight Loss in People Living With Overweight or Obesity ...
This study will look at how much cagrilintide helps people with overweight or obesity and type 2 diabetes lower their body weight.
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