CagriSema confers 15.7% weight loss at 68 weeks for adults with obesity, type 2 diabetes
Key takeaways:
- At 68 weeks, 89.7% of adults with obesity and type 2 diabetes lost 5% or more body weight with CagriSema.
- Detailed results from the REDEFINE 1 and REDEFINE 2 trials will be presented later in 2025.
Adults with obesity and type 2 diabetes receiving once-weekly combination cagrilintide 2.4 mg and semaglutide 2.4 mg lost 15.7% of their body weight at 68 weeks, according to topline data from the REDEFINE 2 trial.
As Healio previously reported in December, CagriSema (Novo Nordisk) conferred a 22.7% weight loss at 68 weeks among adults with obesity and without diabetes in the REDEFINE 1 trial. In the REDEFINE 2 trial, 1,206 adults with obesity or overweight plus type 2 diabetes were randomly assigned to once-weekly CagriSema or placebo for 68 weeks.
In the trial product estimand, adults receiving CagriSema achieved a mean weight reduction of 15.7% at 68 weeks vs. a 3.1% weight loss for those receiving placebo. A weight reduction of 5% or more was achieved by 89.7% of the CagriSema group vs. 30.3% of adults receiving placebo.
In the treatment policy estimand, the CagriSema group achieved weight loss of 13.7% at 68 weeks compared with 3.4% for the placebo group, according to the release.
CagriSema was safe and well-tolerated, with gastrointestinal adverse events being the most common type, and most adverse events were mild to moderate in nature and diminished over time, according to Novo Nordisk.
“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 the release. “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.”
REDEFINE 1 and REDEFINE 2 are two of four trials being conducted as part of the REDEFINE trial program. The company is also conducting REDEFINE 3, which is a phase 3 cardiovascular outcomes trial compared once-weekly CagriSema with placebo in adults with established cardiovascular disease with or without type 2 diabetes, and REDEFINE 4, an 84-week efficacy and safety trial comparing once-weekly CagriSema to once-weekly tirzepatide 15 mg (Zepbound, Eli Lilly) for adults with obesity.
Detailed results for both REDEFINE 1 and REDEFINE 2 will be presented at a scientific conference in 2025, according to Novo Nordisk. The company also said it plans to file for regulatory approval of CagriSema in the first quarter of 2026.
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