Novo Nordisk’s phase 3 REDEFINE 2 trial of CagriSema, its next-generation weight loss and diabetes drug, reported a 15.7% weight loss in patients with type 2 diabetes after 68 weeks. While the drug demonstrated statistically significant weight reduction compared to placebo (3.1%), the results fell short of the 25% weight loss threshold investors had anticipated.
Like the REDEFINE 1 trial announced in December, REDEFINE 2 used a flexible dosing protocol, allowing participants to adjust their dose throughout the study. After 68 weeks, 61.9% of patients had reached the highest dose, meaning a notable portion (38.1%) remained at a lower dose. Since this trial focused on people with overweight or obesity and type 2 diabetes, some participants may have chosen to stay at a lower dose once they achieved blood glucose control, potentially influencing the overall weight loss outcome.
Key Differences Between REDEFINE 1 and REDEFINE 2 Trials
- REDEFINE 1, which studied people without type 2 diabetes, reported 22.7% weight loss which is significantly higher than the 15.7% seen in REDEFINE 2.
- Participants in REDEFINE 2 had a lower baseline weight (225 lbs on average), which may have contributed to the lower percentage of weight loss.
- People with type 2 diabetes often experience less dramatic weight loss on GLP-1-based therapies compared to those without diabetes, likely due to differences in metabolic response.
CagriSema, a fixed-dose combination of semaglutide (the active ingredient in Wegovy and Ozempic) and amylin analogue cagrilintide, is designed to enhance weight loss by suppressing hunger and improving blood sugar control. A secondary analysis, which factored in treatment adherence, showed a slightly lower weight reduction of 13.7%, though 89.7% of participants lost at least 5% of their body weight.
Despite the market reaction, Novo Nordisk remains optimistic, emphasizing that CagriSema’s efficacy in people with type 2 diabetes demonstrates its potential as a viable treatment option. The company expects to file for regulatory approval in early 2026, with detailed trial data to be presented at a scientific conference later this year.
For more information, please visit Fierce Pharma.
