Novo Nordisk has announced via press release the headline results from the kidney outcomes trial FLOW, coming after the decision to stop the trial early due to efficacy that was announced on 10 October 2023, based on a recommendation from an Independent Data Monitoring Committee.
The double-blind trial sought to compare injectable semaglutide 1.0mg 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 (CKD). The trial enrolled 3,533 people with type 2 diabetes and CKD.
The primary endpoint of the trial, which was to demonstrate a statistically significant and superior reduction in kidney disease progression—as well as cardiovascular and kidney death—of 24% for people treated with semaglutide 1.0mg when compared to placebo, was achieved, and superiority of semaglutide 1.0mg vs placebo was confirmed for the confirmatory secondary endpoints.
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. During the trial, it was also noted that semaglutide 1.0mg appeared to have a safe and well-tolerated profile, in line with previous semaglutide 1.0mg trials.
Commenting on the FLOW results, Martin Holst Lange, executive vice president for development at Novo Nordisk, said that “we are very excited about the results from FLOW showing that semaglutide 1.0mg 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.”
The press release also stated that Novo Nordisk expects to file for regulatory approvals of a label expansion for Ozempic in the USA and EU in 2024, and that the full results from FLOW will be presented at a scientific conference later this year.
