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Semaglutide Reduces CKD-Related Events by 24% in Population with T2D and CKD: FLOW Findings Announced
Semaglutide 1.0 mg was superior to placebo across the FLOW trial's 5-part primary endpoint with both CKD and CVD components contributing to risk reduction, said Novo Nordisk.
Among individuals with type 2 diabetes (T2D) and chronic kidney disease (CKD), semaglutide 1.0 mg (Ozempic) reduced the risk of kidney disease progression and cardiovascular (CV)- and renal-related death by 24% compared with placebo, according to an announcement today from Novo Nordisk.
The results are the topline findings from the company’s FLOW kidney outcomes trial, which was halted early, in October 2023, after meeting prespecified criteria for early discontinuation based on efficacy. The company remained blinded to the outcomes until the current readout.
FLOW, launched in 2019, was a randomized, double-blind, parallel-group, placebo-controlled, superiority trial comparing the safety and efficacy of once weekly injectable semaglutide 1.0 mg against placebo as an adjunct to standard of care on kidney outcomes in a cohort of 3533 individuals with T2D and CKD.
CKD define as eGFR ≥50 and ≤75 mL/min/1.73 m2 and UACR >300 and <5000 mg/g or
eGFR ≥25 and <50 mL/min/1.73 m2 and UACR >100 and <5000 mg/g
The study’s primary endpoint combined 5 components measuring the progression of CKD and the risk of kidney and cardiovascular mortality:
- onset of persistent ≥ 50% reduction in eGFR according to the CKD-EPI3 equation compared with baseline
- onset of persistent eGFR (CKD-EPI) < 15 mL/min/1.73 m2
- initiation of chronic kidney replacement therapy (dialysis or kidney transplantation)
- death from kidney disease
- death from CV disease
Secondary outcomes pursued in FLOW included annual rate of change of eGFR, 3-point major adverse cardiovascular events (MACE), and all-cause death.
Analysis of the primary endpoint suggests that both the CKD and CV components contributed to the observed reduction in risk, according to the company. Semaglutide also proved superior to placebo based on analysis of the confirmatory secondary endpoints. The safety and tolerability of semaglutide 1.0 mg in the FLOW study was consistent with previous studies of the 1 mg dose.
"We are very excited about the results from FLOW showing that semaglutide 1.0 mg reduces the risk of kidney disease progression,” Martin Holst Lange, executive vice president for Development at Novo Nordisk said in the company news release. “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.”
Novo Nordisk states that the company expects to file for approval of a label expansion in both the US and the EU in 2024; detailed findings from the FLOW trail will be presented at an upcoming scientific conference this year.
Semaglutide, a glucose-like peptide-1 mimetic, is approved in doses of 0.5 mg, 1.0 mg and 2.0 mg as Ozempic in the US and indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D and to reduce the risk of MACE in adults with T2D and established CV disease.
