CagriSema Demonstrates Significant Weight Loss at 68 Weeks
Approximately 89.7% of patients taking CagriSema achieve the coprimary end point of weight loss of 5% or more compared with 30.3% on the placebo.
A fixed dose of cagrilintide 2.4 mg and semaglutide 2.4 mg (CagriSema) demonstrated statistically significant and superior weight loss compared with the placebo at 68 weeks, according to results from the REDEFINE 2 (NCT05394519) trial.1
Approximately 89.7% of patients taking CagriSema achieve the coprimary end point of weight loss of 5% or more compared with 30.3% on the placebo. | Image Credit: New Africa | stock.adobe.com
“The REDEFINE 2 results confirmed the superior efficacy of CagriSema in people with overweight or obesity and type 2 diabetes”, Martin Holst Lange, executive vice president for development at Novo Nordisk, said in a news release.1 “We look forward to bringing this second pivotal trial to regulatory authorities with the aim of making this next-generation therapy available to the millions of patients in need.”
Investigators also found that patients adhering to CagriSema achieved weight loss of 15.7% after 68 weeks compared with 3.1% with the placebo. The coprimary end point of weight loss of 5% or more was achieved by 89.7% of patients taking CagriSema compared with 30.3% on the placebo.1
The drug was well tolerated in patients, with the most common adverse events being gastrointestinal and waning over time. This is consistent with other GLP-1 receptor agonists.1
The trial included 1206 individuals who had obesity or overweight and type 2 diabetes. The trial had a flexible protocol, which allowed investigators to modify the patients dosing throughout the trial. After the 68 weeks, there were 61.9% of patients receiving the highest dose of the drug. Patients included were 18 years or older, had a body mass index of 27 kg/m2 or greater, and had treatment with either lifestyle interventions or 1 to 3 marketed oral antidiabetic drugs. CagriSema and the placebo were administered once weekly as a subcutaneous injection, and the placebo contained a placebo cagrilintide but the drug semaglutide.1,2
Secondary end points included achievement of 20% or more in weight reduction, relative change in body weight, change in waist circumference, change in hemoglobin A1c, change in systolic and diastolic blood pressure, change in quality of life, change in fasting plasma glucose, number of treatment-emergent adverse events (AEs), and number of serious AEs.2
Although these results hold promise in improving weight loss with semaglutide, in the SURMOUNT-5 (NCT05822830) trial, tirzepatide (Zepbound) showed a 47% greater relative weight loss compared with semaglutide (Wegovy). The average weight loss established with tirzepatide was 20.2% compared with 13.7% for semaglutide, indicating that tirzepatide alone facilitates more weight loss compared with CagriSema, which was nearly 16%.3
Additionally, in a cohort study, 81.8% of patients receiving tirzepatide achieved a 5% or greater weight loss within 1 year compared with 66.5% for semaglutide alone.4
Novo Nordisk expects to file for regulatory approval of the drug in the first quarter of 2026, with results from REDEFINE 1 and REDEFINE 2 being presented at scientific conferences in 2025.1
READ MORE: Obesity Management Resource Center
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