Editor’s note: This story has been updated to reflect a new press release issued by Novo Nordisk clarifying details about the primary endpoint of a study with semaglutide.
Tuesday, Novo Nordisk A/S NGO published key findings from the renal outcomes study, FLOW.
The study compared semaglutide injection 1.0 mg with placebo as an adjunct to standard of care on renal outcomes for the prevention of progression of renal failure and risk of renal and cardiovascular mortality in people with type 2 diabetes and chronic kidney disease ( CKD).
The study enrolled 3,533 people with type 2 diabetes and chronic kidney disease.
In October 2023, Novo Nordisk discontinued the FLOW renal outcomes study based on the recommendation of the independent data monitoring board.
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The study met its primary endpoint by demonstrating a statistically significant and superior reduction in kidney disease progression, as well as cardiovascular and renal death by 24%. for people treated with semaglutide 1.0 mg compared to placebo.
The combined primary endpoint included five components measuring progression of chronic kidney disease and risk of renal and cardiovascular mortality.
CKD and cardiovascular components of the primary endpoint contributed to the risk reduction.
In the study, semaglutide 1.0 mg appeared to have a safe and well-tolerated profile, consistent with previous studies of semaglutide 1.0 mg.
Novo Nordisk plans to seek regulatory approvals for label expansion for Ozempic in the US and EU in 2024.
Semaglutide subcutaneously once weekly is approved in doses of 0.5 mg, 1.0 mg, and 2.0 mg under the brand name Ozempic and is 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. 2 diabetes and established cardiovascular disease.
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Price Action: NVO shares fell 1.79% to $125.66 during the pre-market session on Tuesday.
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