CagriSema demonstrates superior weight loss in adults with obesity, type 2 diabetes in REDEFINE 2 trial: Novo Nordisk
Denmark: CagriSema has demonstrated superior weight loss in adults with obesity or overweight and type 2 diabetes in the REDEFINE 2 trial, Novo Nordisk said in a release.
The headline results from REDEFINE 2, a phase 3 trial in the global REDEFINE programme were announced on Monday. REDEFINE 2 is a 68-week efficacy and safety trial investigating once-weekly subcutaneous CagriSema (a fixed dose combination of cagrilintide 2.4 mg and semaglutide 2.4 mg) compared to placebo. The trial included 1,206 randomised people with obesity or overweight and type 2 diabetes and a mean baseline body weight of 102 kg.
The trial achieved its primary endpoint by demonstrating a statistically significant and superior weight loss at week 68 with CagriSema versus placebo.
The REDEFINE 2 trial was based on a flexible protocol, allowing patients to modify their dosing throughout the trial. After 68 weeks, 61.9% of patients treated with CagriSema were on the highest dose.
When evaluating the effects of treatment, if all people adhered to treatment1, people treated with CagriSema achieved a superior weight loss of 15.7% after 68 weeks compared to 3.1% with placebo. Weight loss of 5% or more after 68 weeks was a co-primary endpoint and was achieved by 89.7% of patients on CagriSema, compared to 30.3% by placebo.
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