A new trial has revealed that adults with obesity and type 2 diabetes who were treated with a once-weekly combination of cagrilintide 2.4 mg and semaglutide 2.4 mg, known as CagriSema, experienced a significant 15.7% reduction in body weight over 68 weeks. This finding comes from the REDEFINE 2 trial, as reported by Novo Nordisk.
In a previous trial, REDEFINE 1, which focused on adults with obesity but no diabetes, CagriSema resulted in a 22.7% weight loss at 68 weeks. The REDEFINE 2 trial involved 1,206 adults with obesity or overweight, all of whom had type 2 diabetes. Participants were randomly assigned to receive either CagriSema or a placebo once a week for 68 weeks.
The results showed that those receiving CagriSema experienced an average weight loss of 15.7%, while the placebo group lost only 3.1%. Moreover, 89.7% of CagriSema users lost at least 5% of their body weight, compared to just 30.3% in the placebo group.
In another analysis, the treatment policy estimand, the CagriSema group achieved a 13.7% weight loss, while the placebo group had a 3.4% reduction.
CagriSema was generally safe and well-tolerated. The most common side effects were gastrointestinal issues, but these were mostly mild to moderate and lessened over time.
Martin Holst Lange, executive vice president for Development at Novo Nordisk, praised the results, stating, “The REDEFINE 2 results confirmed the superior efficacy of CagriSema in people with overweight or obesity and type 2 diabetes.” He added that the company looks forward to submitting the data to regulatory authorities in hopes of making the therapy available to the millions of patients who need it.
The REDEFINE trial program includes four ongoing studies. Besides REDEFINE 1 and 2, Novo Nordisk is conducting REDEFINE 3, a phase 3 cardiovascular outcomes trial, and REDEFINE 4, an 84-week trial comparing CagriSema to tirzepatide (Zepbound, Eli Lilly) in adults with obesity.
The full results of REDEFINE 1 and REDEFINE 2 will be presented at a scientific conference in 2025. Novo Nordisk also plans to seek regulatory approval for CagriSema in the first quarter of 2026.
