The new data suggests Novo Nordisk’s small molecule treatment semaglutide could become the first GLP-1 treatment option for patients with type 2 diabetes and chronic kidney disease (CKD).
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Headline results from Novo Nordisk AS’s kidney outcomes FLOW trial reveal that injectable semaglutide 1.0mg demonstrated a statistically significant and superior reduction in kidney disease progression as well as cardiovascular and kidney death of 24 percent.
This was based on treatment policy estimand: treatment effect regardless of treatment adherence, Novo Nordisk confirmed.
The trial outcome follows an announcement from October 2023 which stated that the trial would be terminated early due to efficacy, based on an Independent Data Monitoring Committee recommendation.
Study design
The randomised, double-blind, parallel-group clinical trial compared injectable semaglutide 1.0mg with placebo as an adjunct to standard of care for prevention of progression of kidney impairment and risk of kidney and cardiovascular.
According to Novo Nordisk, chronic kidney disease (CKD) and cardiovascular components of the primary endpoint in the trial contributed to the risk reduction.
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Novo Nordisk’s small molecule treatment
Significance of the semaglutide trial results
“We are very excited about the results from FLOW showing that semaglutide 1.0 mg reduces the risk of kidney disease progression,” shared Martin Holst Lange, Executive Vice President for Development at Novo Nordisk. “Approximately 40 percent of people with type 2 diabetes have chronic kidney disease, so the positive results from FLOW demonstrate the potential for semaglutide to become the first GLP-1 treatment option for people living with type 2 diabetes and chronic kidney disease.”
Novo Nordisk stated it expects to file for regulatory approvals of a label expansion for Ozempic® in the US and EU this year. The company added that the detailed results from FLOW will be presented at a scientific conference in 2024.
The study was initiated in 2019 and enrolled 3,533 people with type 2 diabetes and chronic kidney disease, the company noted. Confirmatory secondary endpoints in the clinical trial include annual rate of change in eGFR1 (CKD-EPI), MACE (non-fatal myocardial infarction, non-fatal stroke, cardiovascular death) and all-cause death.
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