Novo Nordisk to stop once-weekly injectable semaglutide kidney outcomes trial

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.