A recent Phase 3 clinical trial has demonstrated that the combination of subcutaneous cagrilintide and semaglutide (CagriSema), administered once a week, leads to significant weight loss in patients with type 2 diabetes, as well as obesity or overweight. The study, known as REDEFINE 2, showed that patients treated with CagriSema experienced an average weight loss of 15.7%, far exceeding the 3.1% loss seen in those receiving a placebo.
The findings confirm the efficacy of the CagriSema treatment, meeting the trial’s primary endpoint of significant weight reduction after 68 weeks of treatment. The results have sparked optimism for this combination therapy, with experts noting its potential to improve outcomes for those with obesity and type 2 diabetes.
Martin Holst Lange, executive vice president for development at Novo Nordisk, expressed enthusiasm about the trial’s outcomes, stating, “The REDEFINE 2 results confirmed the superior efficacy of CagriSema in people with overweight or obesity and type 2 diabetes.”
The importance of weight management for people with type 2 diabetes cannot be overstated. Excess weight is a major contributor to the development and exacerbation of the condition. Individuals who are obese face a 3 to 7 times greater risk of developing type 2 diabetes than those with normal weight, and the risk is even higher in individuals with a BMI greater than 35 kg/m². Maintaining a moderate weight loss of 5% to 10% can significantly improve insulin sensitivity, reduce fasting glucose levels, and decrease the need for medication.
Cagrilintide/semaglutide, a fixed-dose combination of cagrilintide (2.4 mg) and semaglutide (2.4 mg), is designed to promote weight loss by curbing appetite and enhancing feelings of fullness. Both drugs play a role in improving insulin function, which is critical for patients suffering from insulin resistance—a condition often worsened by obesity and inactivity.
The REDEFINE 2 study enrolled 1,200 adults with type 2 diabetes and obesity or overweight, evaluating the efficacy and safety of the treatment over a 68-week period. The protocol allowed flexibility in dosing, with 61.9% of participants on the highest dose of CagriSema.
The results were striking. After 68 weeks, 89.7% of those on CagriSema achieved a weight loss of at least 5%, meeting the co-primary endpoint, compared to just 30.3% of those in the placebo group. In total, patients on CagriSema lost an average of 13.7% of their body weight, still significantly greater than the 3.4% loss observed in the placebo group.
Safety was also a key focus of the study. Cagrilintide/semaglutide was well-tolerated, with mild to moderate gastrointestinal side effects reported. These adverse events tended to decrease over time as patients continued their treatment.
With these promising results, Novo Nordisk is now planning to present the findings to regulatory authorities, aiming to bring this next-generation therapy to millions of patients struggling with obesity and type 2 diabetes. “We look forward to making this groundbreaking treatment available to the millions of patients who need it,” Lange concluded.
This new data underscores the growing potential for combined therapies in the treatment of obesity and type 2 diabetes, offering hope for a significant improvement in patient outcomes.
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