Novo Nordisk Says FLOW Trial Achieves Primary Endpoint
(RTTNews) - Novo Nordisk A/S (NVO) announced Tuesday the headline results from the kidney outcomes trial FLOW. The announcement follows the decision to stop the trial early due to efficacy.
The double-blind trial compared injectable semaglutide 1.0 mg 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 trial achieved its primary endpoint by demonstrating a statistically significant and superior reduction in kidney disease progression, major adverse cardiovascular events (MACE) and death of 24% for people treated with semaglutide 1.0 mg compared to placebo.
The combined primary endpoint included five components measuring the progression of CKD and the risk of kidney and cardiovascular mortality. Further, superiority of semaglutide 1 mg vs placebo was confirmed for the confirmatory secondary endpoints.
In the trial, semaglutide 1.0 mg appeared to have a safe and well-tolerated profile in line with previous semaglutide 1.0 mg trials.
Novo Nordisk expects to file for regulatory approvals of a label expansion for Ozempic in the US and EU in 2024.
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