Novo says semaglutide 1.0 mg demonstrates 24% reduction in risk in FLOW trial

Novo Nordisk announced the headline results from the kidney outcomes trial FLOW. The announcement today follows the decision to stop the trial early due to efficacy, which was announced on 10 October 2023, based on a recommendation from an Independent Data Monitoring Committee. The double-blind trial compared injectable semaglutide 1.0 mg with placebo as an adjunct to standard of care for prevention of progression of kidney impairment and risk of kidney and cardiovascular mortality in people with type 2 diabetes and chronic kidney disease, or CKD. The trial enrolled 3,533 people with type 2 diabetes and CKD. The trial achieved its primary endpoint by demonstrating a statistically significant and superior reduction in kidney disease progression, major adverse cardiovascular events, or MACE, and death of 24% for people treated with semaglutide 1.0 mg compared to placebo. The combined primary endpoint included five components measuring the progression of CKD and the risk of kidney and cardiovascular mortality. Both CKD and cardiovascular components of the primary endpoint contributed to the risk reduction. Further, superiority of semaglutide 1 mg vs placebo was confirmed for the confirmatory secondary endpoints. In the trial, semaglutide 1.0 mg appeared to have a safe and well-tolerated profile in line with previous semaglutide 1.0 mg trials. “We are very excited about the results from FLOW showing that semaglutide 1.0 mg reduces the risk of kidney disease progression. Approximately 40% of people with type 2 diabetes have chronic kidney disease, so the positive results from FLOW demonstrate the potential for semaglutide to become the first GLP-1 treatment option for people living with type 2 diabetes and chronic kidney disease,” said Martin Holst Lange, executive vice president for Development at Novo Nordisk.