CagriSema Achieves Superior Weight Loss In Phase 3 Trial

Novo Nordisk has shared encouraging results from REDEFINE 1, a 68-week phase 3 clinical trial evaluating the efficacy and safety of CagriSema. This is a combination of cagrilintide 2.4 mg and semaglutide 2.4 mg a weekly administered dosage. The study compared CagriSema to its individual components (cagrilintide and semaglutide) and a placebo in 3,417 participants with obesity or overweight and at least one related health condition. Participants had an average starting weight of 106.9 kg.

The trial met its primary goal, demonstrating significantly greater weight loss at 68 weeks with CagriSema compared to placebo. Patients treated with CagriSema achieved an average weight loss of 22.7% when fully adhering to treatment, compared to 11.8% with cagrilintide, 16.1% with semaglutide, and just 2.3% with placebo. Notably, 40.4% of those on CagriSema achieved a weight loss of 25% or more, compared to 6.0% with cagrilintide, 16.2% with semaglutide, and 0.9% with placebo.

“We are encouraged by the weight loss profile of CagriSema demonstrating superiority over both semaglutide and cagrilintide in monotherapy in the REDEFINE 1 trial. This was achieved even though only 57% of patients reached the highest CagriSema dose. With the insights obtained from the REDEFINE 1 trial, we plan to further explore the additional weight loss potential of CagriSema,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk.

When analyzed under a different statistical approach accounting for all participants (the treatment policy estimand), CagriSema still led to a substantial weight loss of 20.4%, outperforming 11.5% for cagrilintide, 14.9% for semaglutide, and 3.0% for placebo.

The treatment was generally well-tolerated, with gastrointestinal side effects being the most common. These were mostly mild to moderate and lessened over time, aligning with what is typically observed with GLP-1 receptor agonists. Further insights are anticipated from the second pivotal trial, REDEFINE 2, focusing on individuals with type 2 diabetes and obesity or overweight, with results expected in the first half of 2025.