Novo Nordisk is expanding the clinical evidence around its blockbuster drug semaglutide, marketed as Wegovy, Ozempic, and Rybelsus, with new findings that go beyond weight loss to address eating behaviour itself.
At the European Association for the Study of Diabetes (EASD) congress in Vienna this week, the company is presenting 35 abstracts across its diabetes and obesity portfolio.
A key highlight is the INFORM real-world study, which shows that semaglutide helps reduce “food noise” – intrusive and persistent thoughts about food that often drive overeating. Results from the STEP UP trial further underline its role in controlling cravings, improving body composition, and sustaining weight loss. In addition, the REACH head-to-head study demonstrates Ozempic’s superiority over dulaglutide in lowering cardiovascular risks, including heart attacks and strokes.
Novo is also spotlighting next-generation therapies. Data from the REDEFINE trials suggest that cagrilintide, an amylin analogue, may work as a stand-alone obesity treatment, while CagriSema – semaglutide paired with cagrilintide – is being tested for greater efficacy. Another candidate, Amycretin, a dual GLP-1 and amylin receptor agonist, is showing promise in early trials.
“Semaglutide is today making a real difference in helping people lose weight while also protecting them from cardiovascular events such as heart attacks,” said Martin Holst Lange, Chief Scientific Officer and Executive Vice President, Research & Development at Novo Nordisk. “We are now leading the way in developing next-generation treatments, such as combining cagrilintide with semaglutide or using it as a monotherapy, to better meet the needs of people living with diabetes and obesity.”
The fresh data come as semaglutide continues to fuel Novo’s financial growth. Sales of Wegovy more than doubled in the first half of 2024 to DKK 25.9 billion (about $3.8 billion), reflecting the surging demand for GLP-1 therapies worldwide. In the US, supply has struggled to keep pace with prescriptions, while in Europe, rollout is being phased. Wegovy entered the Indian market earlier this year, where demand is expected to be strong given the scale of lifestyle diseases. India has more than 100 million people with diabetes and over 135 million who are overweight or obese, according to the International Diabetes Federation and ICMR.
The company, however, faces significant legal challenges. In the US, over 1,800 lawsuits allege severe side effects from semaglutide, including gastrointestinal complications, pancreatitis, and vision loss. Potential liabilities are estimated at more than $2 billion. Novo has rejected the claims, stating that semaglutide has been tested extensively with over 33 million patient-years of exposure and that it will vigorously defend itself while continuing to prioritise patient safety.
Novo Nordisk told Business Today: “Semaglutide has been extensively examined in robust clinical development programmes, large real-world evidence studies and has cumulatively over 33 million patient-years of exposure. The efficacy and safety of semaglutide have been extensively demonstrated in people with obesity and overweight with robust evidence for improving health outcomes. Novo Nordisk believes that the allegations in the lawsuits are without merit, and we intend to vigorously defend against these claims. Patient safety is our top priority at Novo Nordisk, and we work closely with the US Food and Drug Administration to continuously monitor the safety profile of our medicines.”
On the safety profile, Dr. Rajiv Kovil, Medical Director and Consultant Diabetologist at Dr. Kovil’s Diabetes Care Center in Mumbai, said that vision-related events such as Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) are extremely rare. “Real-world data from a Danish registry of 450,000 patients showed an incidence of roughly one in 10,000. While the relative risk appears elevated, the absolute risk remains minimal,” he explained. He added that real-world studies cannot establish cause and effect, and ongoing randomized trials, such as the FOCUS study, will provide more evidence regarding semaglutide’s impact on the retina.
Dr. Kovil emphasised that any potential eye events should be managed through careful monitoring and shared decision-making between physicians and patients. “If a patient experiences blurred vision while on semaglutide, evaluation for NAION is recommended. These side effects are very uncommon, and the drug remains an option for managing obesity and related conditions,” he said. He also noted that reported side effects are observed more frequently with older drugs due to longer use, and global pharmacovigilance ensures any abnormal events are promptly flagged.
In India, semaglutide is also the subject of a courtroom case. Hyderabad-based Natco Pharma has challenged Novo’s secondary patents in the Delhi High Court, a move that could determine whether lower-cost alternatives become available. For policymakers, the case raises questions about balancing intellectual property rights with the need to expand access to affordable chronic-disease medicines. Despite these headwinds, semaglutide remains a fast-growing product for Novo.