← Back to Clinical Research · Sponsor: Novo Nordisk · Duration: ~83 weeks · ClinicalTrials.gov: NCT07564414
Currently Recruiting · Clinical Research
REDEFINE — CagriSema vs. Semaglutide in Obesity
A Phase 3 trial comparing CagriSema (cagrilintide + semaglutide) with semaglutide alone for weight management in adults with obesity.
About This Study
What is being studied?
This Phase 3 randomized trial compares two dose levels of CagriSema — a once-weekly combination of the amylin analog cagrilintide and the GLP-1 receptor agonist semaglutide — against semaglutide alone, for weight management in adults with obesity. The primary endpoint is the relative change in body weight from baseline to week 72.
Why does this combination matter?
CagriSema pairs two complementary mechanisms: cagrilintide (an amylin analog affecting satiety and gastric emptying) and semaglutide (a GLP-1 receptor agonist). In earlier Phase 2 work in type 2 diabetes, CagriSema produced substantially greater weight loss than either component alone, which is what this larger trial is designed to confirm.
Eligibility Criteria
Who can participate?
Eligibility is confirmed at a screening visit. The summary below covers the main criteria; our research team reviews the full list with you.
Key Inclusion Criteria
• Adults age ≥ 18 years
• Obesity (BMI ≥ 35 kg/m²)
• With or without type 2 diabetes
• Adults age ≥ 18 years
• Obesity (BMI ≥ 35 kg/m²)
• With or without type 2 diabetes
Key Exclusion Criteria
• More than 5% body weight change within 90 days before screening
• Use of any GLP-1 receptor agonist within the prior 6 months
• More than 5% body weight change within 90 days before screening
• Use of any GLP-1 receptor agonist within the prior 6 months
What Participation Involves
What can I expect?
This is an approximately 83-week study. Participants are randomly assigned to one of two CagriSema dose levels or to semaglutide. Beyond body weight, the trial also tracks BMI, waist circumference, the proportion of participants reaching defined weight-loss thresholds, HbA1c, lipid measures, and quality-of-life measures.
Interested?
Talk to our research team
If you are living with obesity, with or without type 2 diabetes, and would like to learn whether this study is a fit, contact our research team. We will walk you through eligibility and what participation involves. Email research@endotrials.org or call our office.
If you are living with obesity, with or without type 2 diabetes, and would like to learn whether this study is a fit, contact our research team. We will walk you through eligibility and what participation involves. Email research@endotrials.org or call our office.