Novo’s investigational obesity and diabetes drug CagriSema reduces ‘food noise’ and shows benefits in organ and bone health – EASD 2026
The findings extend CagriSema’s clinical evidence beyond weight loss to eating behaviour, fat distribution and preliminary bone-marker results.
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Rhea-AI Summary
Novo Nordisk (NVO) presented new CagriSema data at EASD 2026 showing changes in food-related brain responses and organ fat. A 52-week brain-imaging study in adults with overweight or obesity found reduced cravings and food preoccupation at weeks 22 and 52. The estimated body-weight treatment difference versus placebo was a 22.4% reduction at week 52 (p<0.0001).
In the REIMAGINE 1 diabetes imaging sub-study, CagriSema 2.4 mg/2.4 mg reduced abdominal, liver and pancreas fat versus placebo, alongside 14.3% weight reduction at week 40. A post hoc REIMAGINE 2 analysis showed preliminary signs of balanced bone maintenance alongside 14.2% weight reduction at week 68. CagriSema remains investigational.
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Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
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Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate pointBrain-imaging study showed 22.4% estimated body-weight treatment difference versus placebo at 52 weeks (p<0.0001).
- Moderate pointObesity applications were submitted to the US FDA and Health Canada in December 2025.
- Moderate point. Forward-looking: it has not happened yet and may not happen.Novo expects an FDA weight-management decision in Q4 2026.
- Minor pointEating behaviour improved, with reduced cravings and food preoccupation at 22 and 52 weeks.
- Minor pointBrain responses to high-calorie food cues changed in regions linked to cravings, reward and behavioural control.
4 minor points
- Minor pointREIMAGINE 1 imaging sub-study showed reduced abdominal, liver and pancreas fat versus placebo.
- Minor pointREIMAGINE 1 imaging sub-study showed 14.3% body-weight reduction at week 40 with CagriSema 2.4 mg/2.4 mg.
- Minor pointREIMAGINE 2 bone-marker analysis showed signs of balanced bone maintenance alongside 14.2% weight reduction at week 68.
- Minor pointHigh-dose CagriSema 2.4 mg/7.2 mg phase 3 trial began in adults with obesity in 2026.
Negative
- Minor pointBone findings provide only preliminary reassurance from a post hoc REIMAGINE 2 analysis.
News Explained
Novo says it submitted an obesity New Drug Application to the U.S. FDA and Health Canada in
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- In a year-long functional magnetic resonance imaging (fMRI) study - a non-invasive method to measure brain activity during specific tasks - CagriSema changed how the brain reacted to tempting, high-calorie foods in areas linked to cravings, pleasure, and self-control in people living with overweight or obesity¹
- In adults with type 2 diabetes, CagriSema reduced harmful fat around abdominal organs, including the liver and pancreas. Early findings also suggest that bone health was maintained despite substantial weight loss2,3
- Together, these findings suggest CagriSema may address underlying factors of obesity and type 2 diabetes in the brain and multiple organs and tissues, including bones, not only weight and blood sugar levels1-3
Bagsværd, Denmark, 30 September 2026 – Novo Nordisk today 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
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
"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
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.
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.
Novo is the global healthcare company that believes lasting health starts now. For over a century, we’ve combined leading scientific expertise with a deep understanding of people’s lives. We develop treatments and support that help millions of people make progress they can see, feel and sustain now and in the future. Every day, over 67,000 employees around the world advance our purpose to drive change for lasting health. Through our partnerships, programmes and investments, we’re working to prevent disease, expand access to treatments and reduce our environmental impact to help even more people live healthier lives. For more information, visit novonordisk.com and follow us on Instagram, LinkedIn, TikTok, Facebook, X and YouTube.
Contacts for further information
| Novo Media: | |
| Ambre James-Brown +45 3079 9289 globalmedia@novonordisk.com | Liz Skrbkova (US) +1 609 917 0632 USMediaRelations@novonordisk.com |
| Novo Investors: | |
| Michael Novod +45 3075 6050 nvno@novonordisk.com | Sina Meyer +45 3079 6656 azey@novonordisk.com |
| Christoffer Togo Solgaard-Tullin +45 3079 1471 cftu@novonordisk.com | Max Ung +45 3077 6414 mxun@novonordisk.com |
| Ida Schaap Melvold +45 3077 5649 idmg@novonordisk.com | Mads Berner Bruun +45 3075 2936 mbbz@novonordisk.com |
| Frederik Taylor Pitter (US) +1 609 613 0568 fptr@novonordisk.com | Alex Bruce (US) +1 640 230 0276 axeu@novonordisk.com |
_______________________
References
- Uhre VF, Alex M, Bak N, et al. Effects of CagriSema on appetite, eating behaviour and food cue reactivity using functional MRI in adults with overweight or obesity. Late-breaking abstract, EASD Annual Meeting 2026.
- Pratley RE, Adhya R, Casu A, et al. Efficacy of CagriSema on body composition in participants with early type 2 diabetes: REIMAGINE 1. Late-breaking abstract, EASD Annual Meeting 2026. NCT06323174.
- Haluzík M, Fabricius TW, Gajria R, et al. Effect of CagriSema on bone biomarkers in participants with inadequately controlled type 2 diabetes: REIMAGINE 2. Late-breaking abstract, EASD Annual Meeting 2026. NCT06065540.
- World Health Organization. Obesity and overweight fact sheet. 8 December 2025.
- International Diabetes Federation. IDF Diabetes Atlas, 11th edition.
- Snel M, Jonker JT, Schoones J, et al. Ectopic fat and insulin resistance: pathophysiology and effect of diet and lifestyle interventions. Int J Endocrinol. 2012;2012:983814.
- Taylor R. Type 2 diabetes as a disease of ectopic fat? BMC Med. 2014;12:123.
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FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Novo Nordisk’s CagriSema brain-imaging study show at EASD 2026?
CagriSema changed responses to high-calorie food cues and reduced cravings and food preoccupation in adults with overweight or obesity. At 52 weeks, the estimated body-weight treatment difference versus placebo was a 22.4% reduction (p<0.0001). Eating-behaviour improvements were observed at both 22 and 52 weeks.
When does Novo Nordisk expect an FDA decision on CagriSema for weight management?
Novo expects an FDA decision in Q4 2026. The weight-management application was filed in December 2025. An obesity application was also submitted to Health Canada that month.
What medicines are combined in Novo Nordisk’s investigational CagriSema?
CagriSema combines cagrilintide and semaglutide in a fixed-dose, once-weekly injection under the skin. Cagrilintide acts on amylin receptors, while semaglutide acts on GLP-1 receptors. It is being investigated for adults with overweight or obesity and for adults with type 2 diabetes.