A NEW Phase 3 trial has shown that a combination therapy of cagrilintide and semaglutide (CagriSema) can lead to substantial weight loss and improved glycaemic control in adults with Type 2 diabetes and overweight or obesity. With rising prevalence of both conditions globally, identifying effective pharmacological interventions remains a major clinical priority. In the study, participants receiving CagriSema lost, on average, over 10% more body weight than those receiving placebo.
The randomised, double-blind, placebo-controlled trial was conducted across 12 countries and enrolled 1206 adults with Type 2 diabetes, a body mass index (BMI) of at least 27, and HbA1c between 7% and 10%. Participants were assigned in a 3:1 ratio to receive once-weekly CagriSema (2.4 mg each of cagrilintide and semaglutide) or placebo for 68 weeks, alongside standardised lifestyle interventions. The primary endpoints were percentage change in body weight and the proportion of participants achieving at least 5% weight loss. Additional endpoints included glycaemic outcomes and safety profiles.
At week 68, the mean weight reduction in the CagriSema group was 13.7%, compared with 3.4% in the placebo group, yielding a significant between-group difference of –10.4% (95% CI: –11.2––9.5; p<0.001). A significantly higher proportion of the treatment group achieved weight losses of 5%, 10%, 15% and even 20% or more (p<0.001 for all comparisons). Additionally, 73.5% of patients receiving CagriSema achieved HbA1c levels of 6.5% or lower, compared with just 15.9% in the placebo group. Gastrointestinal adverse events, mostly mild or moderate, were more frequent in the treatment group (72.5%) than in the placebo group (34.4%).
These findings suggest that CagriSema could represent a highly effective therapeutic option for both weight and glycaemic management in people with Type 2 diabetes. While the gastrointestinal side effects warrant consideration, most were transient and manageable. The study’s limitations include its reliance on lifestyle intervention adherence, and a follow-up period limited to 68 weeks. Further long-term data will be critical to understanding sustained benefits and safety. Nonetheless, these results could mark a significant advancement in the medical management of Type 2 diabetes in clinical practice.
Reference
Davies MJ et al. Cagrilintide–Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes. N Engl J Med. 2025;DOI: 10.1056/NEJMoa2502082.
