WASHINGTON (dpa-AFX) - Novo Nordisk's (NVO) Phase 3 REDEFINE 1 trial found that treatment with CagriSema led to a 22.7% weight loss at 68 weeks among patients who adhered to the treatment, compared to 2.3% in the placebo group. When evaluating all participants, regardless of adherence, the CagriSema group achieved a statistically significant weight loss of 20.4%, versus 3.0% for the placebo group.
Additionally, a supportive secondary analysis showed that 50.7% of participants with obesity treated with CagriSema reached non-obesity levels (BMI < 30 kg/m²) by the end of treatment, down from a mean BMI of 38 kg/m² at baseline. In contrast, only 10.2% in the placebo group reached that threshold at 68 weeks.
'In REDEFINE 1, participants saw significant and clinically meaningful weight loss under a protocol that allowed investigators to maintain patients on a submaximal dose if deemed best for the patient. We also witnessed low, single-digit discontinuation rates due to adverse events in both REDEFINE 1 and 2,' said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk.
CagriSema is an investigational product that combines the GLP-1 RA, semaglutide, with an amylin analogue, cagrilintide.
Select confirmatory secondary endpoints showed that, among participants who adhered to treatment, 40.4% of those receiving CagriSema achieved a body weight reduction of ?25%, and 23.1% lost ?30% of their body weight. When analyzed using the treatment policy estimand, 34.7% of participants treated with CagriSema achieved ?25% weight reduction, while 19.3% achieved ?30%.
In a prespecified analysis of 252 participants, the relative reduction in fat mass and lean soft-tissue mass from baseline to week 68 was -35.7% (fat mass) and -14.4% (lean soft-tissue mass) for those treated with CagriSema, compared to -5.7% and -4.3%, respectively, in the placebo group.
The New England Journal of Medicine (NEJM) has published results from Novo Nordisk's Phase 3 REDEFINE 1 trial, which evaluated the efficacy and safety of investigational CagriSema combined with lifestyle interventions for weight loss in adults with obesity or overweight-specifically those who have a weight-related medical complication but do not have diabetes.
The company noted that the REDEFINE 1 trail met its co-primary endpoints and achieved statistically significant and clinically meaningful weight loss at 68 weeks in patients taking CagriSema versus placebo.
The findings, along with results from the related Phase 3 REDEFINE 2 study conducted in adults with overweight or obesity and type 2 diabetes, were presented today at a scientific symposium during the American Diabetes Association's (ADA) 85th Scientific Sessions and simultaneously published in NEJM.
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