CagriSema 2.4 mg / 2.4 mg demonstrated 22.7% mean weight reduction in adults with overweight or obesity in REDEFINE 1, published in New England Journal of Medicine

• Data presented simultaneously at the American Diabetes Association’s 85^th Scientific Sessions, showed mean weight reduction in the highest range of efficacy observed with existing weight loss interventions¹
• When adhering to treatment, weight loss of ≥5%, ≥20%, ≥25%, and ≥30% was observed in 97.6%, 60.2%, 40.4% and 23.1% of patients respectively at 68 weeks^1*
• The REDEFINE clinical programme is ongoing to further investigate efficacy and safety of CagriSema, including recently initiated REDEFINE 11²
  
  

Bagsværd, Denmark, 22 June – Today, The New England Journal of Medicine (NEJM) published results from Novo Nordisk’s phase 3 REDEFINE 1 trial evaluating the efficacy and safety of investigational CagriSema plus lifestyle interventions for weight loss in adults with obesity or overweight who have a weight-related medical complication and without diabetes.¹ REDEFINE 1 met its co-primary endpoints and achieved statistically significant and clinically meaningful weight loss at 68 weeks in patients taking CagriSema versus placebo.¹ These data, along with the related phase 3 REDEFINE 2 study conducted in adults with overweight or obesity and type 2 diabetes, were presented today during a scientific symposium at the American Diabetes Association’s (ADA) 85th Scientific Sessions and published in NEJM.

“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. “These results reinforce our confidence in CagriSema, and we continue to study the potential of this combination through the REDEFINE trials.”

CagriSema is an investigational product that combines the GLP-1 RA, semaglutide, with an amylin analogue, cagrilintide. The REDEFINE 1 trial found that treatment with CagriSema resulted in greater weight loss of 22.7% at 68 weeks versus 2.3% in the placebo group if all patients adhered to treatment.^1* When evaluating the treatment effect regardless of adherence, those treated with CagriSema achieved statistically significant weight loss of 20.4% at 68 weeks versus 3.0% for the placebo group.^1** In addition, a supportive secondary analysis showed that half (50.7%) of trial participants with obesity treated with CagriSema reached the threshold for non-obesity (BMI < 30 kg/m²) at the end of treatment, from a mean BMI of 38 kg/m² at the start of treatment. In the placebo group,10.2% reached that threshold at 68 weeks.¹