Editor’s note: This story has been updated to reflect a new press release issued by Novo Nordisk that clarifies details around the primary endpoint of a semaglutide trial.
Tuesday, Novo Nordisk A/S NVO released the headline results from the kidney outcomes trial, FLOW.
The study compared injectable semaglutide 1.0 mg with placebo as an adjunct to the standard of care on kidney outcomes 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.
In October 2023, Novo Nordisk stopped the kidney outcomes trial FLOW based on the independent Data Monitoring Committee’s recommendation.
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The trial achieved its primary endpoint by demonstrating a statistically significant and superior reduction in kidney disease progression as well as cardiovascular and kidney 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.
CKD and cardiovascular components of the primary endpoint contributed to the risk reduction.
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 U.S. and EU in 2024.
Once-weekly subcutaneous semaglutide is approved in 0.5 mg, 1.0 mg, and 2.0 mg doses under the brand name Ozempic and indicated as an adjunct to diet and exercise for type 2 diabetes and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.
Price Action: NVO shares are down 1.79% at $125.66 during the premarket session on the last check Tuesday.
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