Novo Nordisk has announced positive results from a phase 3 trial evaluating Ozempic (semaglutide) in adults with type 2 diabetes (T2D) and chronic kidney disease (CKD).
Results from the FLOW trial were presented at the 84th Annual Scientific Sessions of the American Diabetes Association.
According to Diabetes UK, out of the 5.6 million people living with diabetes in the UK, 90% have T2D.
Approximately 40% of people living with T2D will eventually go on to develop CKD, a gradual loss of kidney function over time that affects more than 800 million people worldwide.
Previously presented at the 61st European Renal Association Congress and published in the New England Journal of Medicine, the trial compared once-weekly 1mg injectable Ozempic with placebo as an adjunct to standard of care on kidney outcomes for reducing the risk of progression of kidney impairment and the risk of kidney and cardiovascular mortality in 3,533 people living with T2D and CKD.
Indicated along with diet and exercise, Ozempic injection is a once-weekly glucagon-likepeptide-1 receptor (GLP-1) agonist to help improve blood sugar in adults with T2D and to reduce cardiovascular events in adults with T2D with known heart disease.
Results demonstrated a 24% reduction in the risk of kidney disease progression and cardiovascular and kidney mortality compared to placebo, and Ozempic 1mg demonstrated superiority to placebo for all secondary outcomes assessed, including a significant reduction in the mean annual glomerular filtration rate.
In addition, the risk of major cardiovascular events and the risk of death were significantly lower in the Ozempic group, with fewer serious adverse events reported compared to the placebo group.
After a median follow-up of just over three years, Novo stopped the FLOW study due to the efficacy of Ozempic in preventing kidney disease-related incidences and submitted a label extension application, which was accepted for review by the US Food and Drug Administration, with a decision anticipated in January 2025.
Anna Windle, senior vice president, clinical development, medical and regulatory affairs, Novo, commented: “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.”