Novo Nordisk’s CagriSema shows weight loss in people living with obesity and type 2 diabetes
Novo Nordisk has announced promising results from the REDEFINE 2 trial, a pivotal phase 3 study investigating the efficacy and safety of CagriSema in people living with obesity or overweight and type 2 diabetes.
CagriSema is a once-weekly subcutaneous treatment that combines cagrilintide 2.4 mg and semaglutide 2.4 mg. The 68-week study included 1,206 participants with a mean baseline body weight of 102 kg.
Results showed that among those who adhered to the treatment, individuals receiving CagriSema achieved an average weight loss of 15.7 per cent after 68 weeks, compared to 3.1 per cent with placebo. Additionally, 89.7 per cent of participants on CagriSema achieved at least 5 per cent weight loss, compared to 30.3 per cent in the placebo group.
Using the treatment policy estimand, which accounts for all participants, CagriSema still demonstrated superior weight loss of 13.7 per cent versus 3.4 per cent with placebo.
The study highlighted that CagriSema was well tolerated, with gastrointestinal side effects being the most commonly reported adverse events. These were generally mild to moderate and diminished over time, consistent with the GLP-1 receptor agonist class.
“The REDEFINE 2 results confirm the strong potential of CagriSema in addressing weight management for people living with obesity or overweight and type 2 diabetes,” said Martin Holst Lange, Executive Vice President for Development at Novo Nordisk. “We are excited to progress towards regulatory approval and bring this innovative treatment to those who need it.”
Novo Nordisk plans to submit CagriSema for regulatory approval in early 2026. Full results from the REDEFINE 1 and REDEFINE 2 trials will be presented at a scientific conference later in 2025.
The REDEFINE clinical trial programme is a phase 3 development initiative evaluating CagriSema for obesity and type 2 diabetes management. The programme includes:
REDEFINE 1 – A 68-week trial in adults living with obesity or overweight (without type 2 diabetes).
REDEFINE 2 – A 68-week trial in adults living with obesity or overweight and type 2 diabetes.
REDEFINE 3 – A cardiovascular outcomes trial in adults living with established cardiovascular disease.
REDEFINE 4 – An 84-week trial comparing CagriSema to tirzepatide in adults living with obesity.