FLOW: Semaglutide slows CKD progression, cuts risks for kidney, CV death in diabetes
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Adults with type 2 diabetes and chronic kidney disease have a 24% lower risk for kidney disease progression and cardiovascular and kidney mortality with once-weekly semaglutide 1 mg, according to topline results from the FLOW trial.
The FLOW trial enrolled 3,533 people with type 2 diabetes and CKD. Participants were randomly assigned to receive either once-weekly semaglutide 1 mg (Ozempic, Novo Nordisk) or placebo as an adjunct to standard of care. A composite primary endpoint consisting of five components was used: onset of persistent 50% or greater reduction in estimated glomerular filtration rate (eGFR) compared with baseline; onset of persistent eGFR of less than 15 mL/min/1.73 m2; initiation of chronic kidney replacement therapy; death from kidney disease; and death from cardiovascular disease. Confirmatory secondary endpoints included eGFR change, occurrence of major adverse CV events and all-cause mortality.
The semaglutide group had a 24% lower risk for the composite primary endpoint compared with the placebo group. The risk reduction was observed among both the CKD and CV components of the endpoint. Semaglutide was also superior compared with placebo in the secondary endpoints.
Semaglutide 1 mg had a well-tolerated adverse event profile in the FLOW trial that was similar to previous trials, according to a press release from Novo Nordisk.
As Healio previously reported, the FLOW trial ended early in October 2023 after Novo Nordisk announced the study met certain pre-specified criteria in an interim analysis.
“We are very excited about the results from FLOW showing that semaglutide 1 mg reduces the risk of kidney disease progression,” Martin Holst Lange, executive vice president for development at Novo Nordisk, said in the release. “Approximately 40% of people with type 2 diabetes have CKD, 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 CKD.”
Novo Nordisk plans to file for a label expansion of Ozempic in the U.S. and European Union in 2024, according to the release. Semaglutide is currently approved for the treatment of type 2 diabetes and obesity.
Full results from the FLOW trial will be presented at a scientific conference later in 2024, according to the release.
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