Novo Nordisk Shares Positive Phase 3 Results for Ozempic in Diabetes, Kidney Disease

Novo Nordisk has reported favorable outcomes from a phase 3 trial assessing Ozempic (semaglutide) in individuals with type 2 diabetes (T2D) and chronic kidney disease (CKD). The findings from the FLOW trial were unveiled at the 84th Annual Scientific Sessions of the American Diabetes Association.

According to Diabetes UK, around 90% of the 5.6 million people with diabetes in the UK have T2D. Approximately 40% of T2D patients are likely to develop CKD, a condition characterized by the gradual deterioration of kidney function, which impacts over 800 million people globally.

Previously disclosed at the 61st European Renal Association Congress and published in the New England Journal of Medicine, the FLOW trial compared the effects of a once-weekly 1mg injectable dose of Ozempic to a placebo, alongside standard care, on kidney outcomes. The study aimed to assess the reduction in risk of kidney function decline and mortality related to kidney and cardiovascular issues in 3,533 patients with T2D and CKD.

Ozempic, prescribed in conjunction with diet and exercise, is a glucagon-like peptide-1 receptor (GLP-1) agonist administered once a week. Its purpose is to improve blood sugar levels in adults with T2D and decrease cardiovascular events in those with existing heart disease.

The trial results indicated a 24% decrease in the risk of kidney disease progression and mortality related to kidney and cardiovascular conditions when compared to placebo. Additionally, Ozempic 1mg outperformed the placebo in all secondary outcomes measured, including a notable reduction in the mean annual glomerular filtration rate. The study also revealed a significantly lower incidence of major cardiovascular events and mortality in the Ozempic group, with fewer serious adverse events reported compared to the placebo group.

After a median follow-up period of slightly over three years, Novo Nordisk halted the FLOW study due to the demonstrated efficacy of Ozempic in preventing kidney disease-related incidents. The company has since submitted a label extension application, which has been accepted for review by the US Food and Drug Administration, with a decision expected in January 2025.

Anna Windle, senior vice president of clinical development, medical and regulatory affairs at Novo Nordisk, remarked: "The results from the FLOW trial represent important data as we look to better understand what GLP-1 treatment options could mean for this patient population."