Novo Nordisk’s semaglutide cuts death risk in diabetics with CKD in Phase III trial
Novo Nordisk’s semaglutide cuts death risk in diabetics with CKD in Phase III trial
Published: May 24, 2024
By Tristan Manalac
BioSpace
Novo Nordisk’s best-selling GLP-1 receptor agonist semaglutide significantly lowered the risk of death in type 2 diabetes patients with chronic kidney disease, according to a Friday readout of the pharma’s Phase III FLOW trial.
The results—which were simultaneously presented at the 61st European Renal Association congress in Stockholm and published in The New England Journal of Medicine—showed that semaglutide lowered the risk of death from any cause by 20% versus placebo. This effect was statistically significant with a p-value of 0.01.
The GLP-1 analog also hit the study’s primary composite endpoint, which consists of kidney failure onset, at least a 50% deterioration in kidney function and kidney-related or cardiovascular death. This composite outcome was 24% less likely to occur in patients treated with semaglutide compared with placebo.
Semaglutide also met its key secondary endpoints, lowering the likelihood of major cardiovascular events by 18% and slowing the progression of the disease.
Taken together, these findings suggest that semaglutide can significantly curb “the risk of clinically important kidney outcomes and death from cardiovascular causes” in type 2 diabetes patients suffering from chronic kidney disease (CKD), the authors of the NEJM paper wrote.
A GLP-1 receptor agonist, semaglutide works by mimicking the GLP-1 hormone and activating its corresponding receptor, promoting the secretion of insulin from the pancreas in response to blood sugar levels. This mechanism of action allows semaglutide to help suppress appetite.
Semaglutide is approved as Ozempic for type 2 diabetes and Wegovy for chronic weight management. In March 2024, the FDA approved the expansion of Wegovy’s label to lower the risk of cardiovascular death, heart attack and stroke in overweight and obese adults with cardiovascular disease.
Friday’s readout comes from the Phase III FLOW trial, a randomized, placebo-controlled, quadruple-masked study designed to evaluate the impact of semaglutide on the progression of renal impairment in diabetes patients with CKD.
In October 2023, Novo announced that it would stop FLOW ahead of schedule in line with an independent data monitoring committee’s recommendation to end the study early, noting that FLOW “met certain pre-specified criteria for stopping the trial early for efficacy.”
Novo eventually unveiled headline data from FLOW in March 2024, showing that semaglutide elicited a significant 24% drop in the risk of kidney disease progression, kidney death and major adverse cardiovascular events versus placebo. The GLP-1 receptor agonist also significantly improved both the CKD and cardiovascular components of the primary endpoint.
Novo intends to file an application this year to expand semaglutide’s label to cover CKD.
Source: BioSpace
