The decision to stop the trial is based on a recommendation from the independent Data Monitoring Committee (DMC) concluding that the results from an interim analysis met certain pre-specified criteria for stopping the trial early for efficacy.
"Based on the decision to stop the trial at interim, the process of closing the trial will be initiated. To protect the integrity of the trial, Novo Nordisk remains blinded to the results until trial completion," the Company stated.
Novo Nordisk expects that FLOW will read out during the first half year of 2024.
FLOW is a randomised, double-blind, parallel-group, placebo-controlled, superiority trial comparing injectable semaglutide 1.0 mg with placebo as an adjunct to standard of care on kidney outcomes for prevention of progression of renal impairment and risk of renal and cardiovascular mortality in people with type 2 diabetes and chronic kidney disease (CKD). 3,534 people are enrolled in the trial which has been conducted in 28 countries at more than 400 investigator sites. The FLOW trial was initiated in 2019.
The key objective of the FLOW trial is to demonstrate delay in progression of CKD and to lower the risk of kidney and cardiovascular mortality through the composite primary endpoint consisting of the following five components: onset of persistent ≥ 50% reduction in eGFR1 according to the CKD-EPI2 equation compared with baseline, onset of persistent eGFR1 (CKD-EPI2) < 15 mL/min/1.73 m2, initiation of chronic kidney replacement therapy (dialysis or kidney transplantation), death from kidney disease or death from cardiovascular disease in people with type 2 diabetes and chronic kidney disease. Key secondary endpoints include annual rate of change in eGFR1 (CKD-EPI2), major adverse cardiovascular events (non-fatal myocardial infarction, non-fatal stroke, cardiovascular death) and all-cause death. The trial protocol provides for an interim analysis when a prespecified number of primary endpoint events has occurred.
Once-weekly subcutaneous semaglutide is approved in 0.5, 1.0 and 2.0 mg doses under the brand name Ozempic and indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.
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