In the FLOW clinical trial, which enrolled 3,533 participants with type 2 diabetes and chronic kidney disease (CKD), Ozempic showed positive outcomes in preventing the progression of kidney impairment and the risk of kidney and cardiovascular death
Novo Nordisk Danish headquarters in Bagsværd. (Credit: Jens Lindhe/ Novo Nordisk A/S)
Danish pharmaceutical company Novo Nordisk has announced positive outcomes for its diabetes drug Ozempic (semaglutide) in the top-line results from the FLOW clinical trial.
FLOW was a randomised, double-blind, parallel-group, placebo-controlled, superiority trial that compared Ozempic 1mg with placebo, as an adjunct to standard of care.
The study enrolled 3,533 participants with type 2 diabetes and chronic kidney disease (CKD), in 28 countries at around 400 investigator sites.
In the FLOW trial, Ozempic showed positive outcomes in preventing the progression of kidney impairment and the risk of kidney and cardiovascular mortality.
In October last year, Novo Nordisk decided to stop the trial early due to efficacy, based on a recommendation from an Independent Data Monitoring Committee.
Novo Nordisk executive vice president for development Martin Holst Lange said: “We are very excited about the results from FLOW showing that semaglutide 1.0 mg reduces the risk of kidney disease progression.
“Approximately 40% 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.”
The FLOW clinical trial met its primary endpoint of statistically significant and superior reduction in kidney disease progression, along with cardiovascular and kidney death, in 24% of people treated with semaglutide 1mg.
The combined primary endpoint included five components measuring the progression of CKD and the risk of kidney and cardiovascular mortality.
In addition, semaglutide 1mg appeared to have a safe and well-tolerated profile, which is consistent with previous clinical trials of semaglutide 1mg.
The Danish pharmaceutical company intends to file for regulatory approvals of a label expansion for Ozempic in the US and EU in 2024.
Recently, US-based biotechnology company Neomorph has partnered with Novo Nordisk to discover, develop, and commercialise molecular glue degraders.