VIA GRAPHIC PLUS | Bagsværd, Denmark – Novo Nordisk announced new data on how CagriSema works inside both the brain and body, presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2026.
In a 52-week functional magnetic resonance imaging (fMRI) study, a brain scan technique that shows how the brain responds to cues, in adults with overweight or obesity, CagriSema modified brain responses to high-calorie food cues in regions linked to cravings, reward, sensory processing and behavioural control. Additionally, CagriSema substantially improved eating behaviour, reduced ‘food noise’, cravings, hunger, appetite, and food-related thoughts and improved craving control after both 22 and 52 weeks of treatment.
In the study, also awarded a Best Abstract Award at EASD 2026, the improvements were also associated with a 22.4% reduction in body weight versus placebo at 52 weeks (estimated treatment difference at 52 weeks, p<0.0001).¹ Overall, the results suggest CagriSema may help address biological drivers that make sustained weight management difficult, including hunger, cravings and food preoccupation, not just calorie intake.
Separately, in a diabetes MRI sub-study, which evaluated whole body metabolic effects in the phase 3a REIMAGINE 1 trial in adults with early type 2 diabetes, CagriSema 2.4 mg/2.4 mg produced significant reductions in fat in the abdomen and around the liver and pancreas fat versus placebo, alongside a 14.3% body-weight reduction at week 40.² In addition, a post hoc analysis of bone markers of the phase 3 REIMAGINE 2 trial in adults with inadequately controlled type 2 diabetes showed signs of healthy balance in bone maintenance alongside a 14.2% body-weight reduction with CagriSema 2.4 mg/2.4 mg at week 68, providing what the study authors describe as “preliminary reassurance regarding bone changes with CagriSema in type 2 diabetes”.³
“For many people with overweight or obesity, we know that ‘food noise’ is an ongoing challenge to achieving health goals. Based on this brain scan (fMRI) data, we are encouraged by the potential of CagriSema to help reduce measurable ‘food noise’ coupled with a 22.4% reduction in body weight after 52 weeks,” said Martin Holst Lange, executive vice president, chief scientific officer and head of Research & Development at Novo.
“At the same time, people living with overweight, obesity and type 2 diabetes are increasingly looking beyond the amount of weight lost to the quality of that weight loss. The data presented at EASD 2026 add to emerging evidence that the amylin component of CagriSema may influence disease biology across the brain and multiple organs beyond weight loss alone.”
Taken together, the three studies suggest investigational CagriSema may act on obesity and type 2 diabetes through coordinated effects on eating behaviour, fat levels in and around the organs, and bone remodelling – mechanisms that extend well beyond weight reduction itself.
“What is striking about this behavioural and brain fMRI data is that, after 52 weeks, across all measures of appetite and eating behaviour, people with overweight and obesity had substantially reduced food cravings and sustained changes in the brain response to viewing pictures of high-calorie foods,” said Professor Tony Goldstone, Clinical Professor in PsychoNeuroEndocrinology and Consultant Endocrinologist, Imperial College London. “This was coupled with reduced energy intake and body weight, showing the association between tackling ‘food noise’ and successful and sustained weight loss.”
CagriSema is Novo Nordisk’s next-generation investigational obesity and diabetes treatment. Novo Nordisk submitted an NDA for obesity to the US FDA and Health Canada in December 2025. In 2026, High-dose CagriSema 2.4 mg/7.2 mg, an efficacy and safety phase 3 trial, was initiated in adults with obesity.
Obesity and type 2 diabetes remain among the largest, most under-treated chronic disease burdens globally. According to the World Health Organization, more than one billion people worldwide are now living with obesity, and the International Diabetes Federation estimates that approximately 589 million adults are living with diabetes, the majority with type 2 diabetes.⁴,5
Beyond weight itself, obesity drives risk for cardiovascular disease, metabolic dysfunction-associated steatotic liver disease (MASLD), chronic kidney disease and multiple cancers.6 Many people describe persistent thoughts about food – sometimes called ‘food noise’ – as a barrier to sustained weight loss, and current therapies have historically been evaluated primarily on scale weight rather than on the underlying drivers of eating behaviour or on where fat is stored in the body. Ectopic fat — fat accumulated in the liver, pancreas and around abdominal organs — is a key contributor to insulin resistance and progression of type 2 diabetes.7
The CagriSema studies presented at EASD 2026 are designed to address these gaps by measuring how the therapy affects the brain, behaviour, and body — not weight alone.
About CagriSema
Once-weekly subcutaneous CagriSema is being investigated by Novo as a treatment for adults with overweight or obesity (REDEFINE programme) and as a treatment for adults with type 2 diabetes (REIMAGINE programme). CagriSema is a fixed-dose combination of a long-acting amylin receptor agonist, cagrilintide, and a GLP-1 receptor agonist, semaglutide.
Novo filed a New Drug Application with the U.S. Food and Drug Administration in December 2025 for CagriSema for weight management, demonstrating the company’s commitment to obesity innovation. A decision is expected in Q4 2026. CagriSema is not yet approved by the Philippine FDA for the uses described.
About the REDEFINE programme
REDEFINE is a phase 3 clinical development programme with once-weekly subcutaneous CagriSema in obesity. The global clinical trial programme includes two pivotal phase 3 trials that enrolled approximately 4,600 adults with overweight or obesity. The phase 3 trial programme includes:
- REDEFINE 1 – a 68-week efficacy and safety phase 3 trial of once-weekly CagriSema 2.4 mg/2.4 mg, cagrilintide 2.4 mg and semaglutide 2.4 mg versus placebo in 3,417 adults with obesity or overweight with one or more comorbidities and without type 2 diabetes.
- REDEFINE 2 – a 68-week efficacy and safety phase 3 trial of once-weekly CagriSema 2.4 mg/2.4 mg versus placebo in 1,206 adults with type 2 diabetes and either obesity or overweight.
- REDEFINE 3 – an event-driven cardiovascular outcomes phase 3 trial of once-weekly CagriSema 2.4 mg/2.4 mg versus placebo in 7,000 adults with established cardiovascular disease with or without type 2 diabetes.
- REDEFINE 8 – a 104-week efficacy and safety phase 3 trial of once-weekly CagriSema 2.4 mg/2.4 mg versus placebo in 400 adults with obesity, including assessments on body composition. The trial includes a 52-week extension phase investigating maintenance of weight loss with CagriSema 2.4 mg/2.4 mg or a dose-tapering algorithm.
- REDEFINE 9 – a 68-week efficacy and safety phase 3 trial of once-weekly CagriSema 1.7 mg/1.7 mg and CagriSema 1.0 mg/1.0 mg versus placebo in 300 adults with overweight or obesity.
- REDEFINE 11 – an 80-week efficacy and safety phase 3 trial of once-weekly CagriSema 2.4 mg/2.4 mg versus placebo in 600 adults with obesity. The trial includes an 80-week extension phase investigating the maintenance of weight loss.
- High-dose CagriSema 2.4 mg/7.2 mg, an efficacy and safety phase 3 trial, was initiated in adults with obesity in 2026.
About the REIMAGINE programme
REIMAGINE is a phase 3 clinical development programme with once-weekly subcutaneous CagriSema in type 2 diabetes. The global clinical trial programme consists of several phase 3 trials.
REIMAGINE 1 was a 40-week efficacy and safety phase 3 trial of CagriSema 2.4 mg/2.4 mg and 1 mg/1 mg once-weekly versus placebo in 189 adults with type 2 diabetes inadequately controlled on diet and exercise. REIMAGINE 2 was a 68-week efficacy and safety phase 3 trial of CagriSema 2.4 mg/2.4 mg and 1 mg/1 mg once-weekly versus semaglutide 2.4 mg, semaglutide 1 mg, cagrilintide 2.4 mg, and placebo in 2,713 adults with type 2 diabetes inadequately controlled with metformin with or without an SGLT2 inhibitor. REIMAGINE 3 was a 40-week efficacy and safety phase 3 trial of CagriSema 2.4 mg/2.4 mg and 1 mg/1 mg once-weekly versus placebo in 274 adults with type 2 diabetes as an add-on to once-daily basal insulin with or without metformin.
Additionally, the REIMAGINE 4 and REIMAGINE 5 trials evaluated CagriSema 2.4 mg/2.4 mg and 1 mg/1 mg, respectively, versus tirzepatide in adults with type 2 diabetes on standard of care.
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