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Medical Daily
Medical Daily
Dorothy Brooks

Participants Taking CagriSema Showed Changed Brain Responses to High-Calorie Food Images in Novo Study as FDA Decision Nears

Novo Nordisk said Sept. 30 that adults with overweight or obesity who took its experimental drug CagriSema for a year showed sustained changes in how their brains responded to pictures of high-calorie food. They also reported fewer cravings and less food noise, the constant thoughts about eating that many people describe.

The findings were presented as a late-breaking abstract at the European Association for the Study of Diabetes (EASD) annual meeting in Milan. They have not been published in a peer-reviewed journal, and Novo has not released the number of participants or detailed brain scan results.

The timing matters for millions of Americans weighing weight-loss treatment. Novo has submitted its CagriSema application to the FDA, and the company says a decision is expected in the fourth quarter of 2026. If approved, it would add another weekly injection to a crowded and expensive market.


Inside the Brain Scan Study

The 52-week, placebo-controlled study used functional MRI, which tracks changes in blood flow as a sign of brain activity. Participants viewed images of high-calorie foods while researchers measured responses in brain regions linked to cravings, reward, sensory processing, and behavioral control, according to Novo's announcement.

Improvements in cravings, hunger, appetite, and food-related thoughts were measured at both 22 and 52 weeks. Novo said the estimated difference in body weight compared with placebo was a 22.4% reduction at week 52. The abstract won the meeting's Best Abstract Award.

"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 Prof. Tony Goldstone of Imperial College London in Novo's announcement.

Martin Holst Lange, Novo's chief scientific officer and head of research and development, said the company is "encouraged by the potential of CagriSema to help reduce measurable 'food noise.'"


Two Hormones in One Weekly Shot

CagriSema combines two drugs. Semaglutide, the ingredient in Wegovy and Ozempic, mimics the gut hormone GLP-1. Cagrilintide mimics amylin, a hormone released with insulin that helps signal fullness. Novo is betting that pairing them produces more weight loss than either drug alone.

In the large REDEFINE 1 trial published in the New England Journal of Medicine, adults without diabetes lost an average of 20.4% of their body weight over 68 weeks on CagriSema, compared with 3.0% on placebo. Gastrointestinal side effects such as nausea were common, affecting about 80% of people on the drug versus 40% on placebo. Most were mild to moderate.

Novo presented other data at the same meeting. An MRI sub-study of the REIMAGINE 1 trial followed 189 adults with early type 2 diabetes for 40 weeks and found reductions in abdominal fat and in fat around the liver and pancreas. Their body weight fell 14.3%.

A separate after-the-fact analysis of the REIMAGINE 2 trial, which included 2,713 adults with type 2 diabetes over 68 weeks, looked at blood markers of bone health. Novo said it offered "preliminary reassurance regarding bone changes with CagriSema." The analysis did not measure fractures or bone density. People with diabetes often lose less weight on these drugs than people without it.


Surrogate Measures, Not Proof of Better Health

Brain scan changes and self-reported cravings are surrogate measures. They suggest how a drug might work, but they do not show that patients live longer or avoid heart attacks. As Patient Care Online noted, the findings "link changes in food-cue responses with weight loss but do not establish that altered brain activity caused the weight reduction."

All of the studies were sponsored by Novo Nordisk, and the company's announcement did not include comments from independent experts. Without the participant count and full results, outside scientists cannot yet judge how strong or consistent the brain findings are.

There is also competitive context. In February 2026, Novo reported that CagriSema did not meet its main goal in REDEFINE 4, an 84-week head-to-head trial designed to show its weight loss was not inferior to that of tirzepatide, sold as Zepbound. That result may shape how doctors and insurers view the drug if it reaches the U.S. market.


Cost and Access Questions Ahead of Approval

The FDA decision is the next milestone. Novo submitted its application in December 2025, and no public action date has been announced. Pricing, insurance coverage, and supply plans remain unknown.

For now, CagriSema is not available outside clinical trials. People interested in weight-loss medication can talk with a clinician about FDA-approved options, insurance coverage, and side effects. Buying unapproved CagriSema or compounded versions online carries real safety risks, since those products are not reviewed by the FDA.

Readers who already take a GLP-1 drug should not switch or stop treatment based on conference results. MedicalDaily's preview of this year's EASD meeting covered other obesity drugs under study. A full peer-reviewed paper will be needed to judge the brain scan findings and how they compare with drugs already on pharmacy shelves.


Key Questions Answered

What is CagriSema? It is an experimental once-weekly injection from Novo Nordisk that combines semaglutide with cagrilintide, an amylin-like drug. It is not FDA-approved.

What did the brain scans show? Novo said participants showed sustained changes in brain responses to high-calorie food images after 52 weeks, along with fewer cravings and less food noise.

Does this prove the drug works through the brain? No. The scans show an association. They do not prove that brain changes caused the weight loss.

When could the FDA decide? Novo says a decision is expected in the fourth quarter of 2026. No exact date has been made public.

Can people get CagriSema now? Only through clinical trials. Products sold online as CagriSema are not FDA-approved and may be unsafe.

Who funded the research? Novo Nordisk sponsored the studies presented at EASD 2026.

Published by Medicaldaily.com

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