Semaglutide Lowers Death Risk in Diabetic CKD Patients in Phase III Trial

Novo Nordisk's best-selling GLP-1 receptor agonist, semaglutide, has demonstrated significant efficacy in lowering the risk of death among type 2 diabetes patients suffering from chronic kidney disease (CKD). According to recent findings from the Phase III FLOW trial, semaglutide reduced the risk of death from any cause by 20% compared to a placebo group. These results were deemed statistically significant, with a p-value of 0.01.

The findings were disclosed simultaneously at the 61st European Renal Association congress in Stockholm and were published in The New England Journal of Medicine. Semaglutide proved its effectiveness by also achieving the primary composite endpoint of the study, which includes the onset of kidney failure, at least a 50% decline in kidney function, and death related to kidney or cardiovascular issues. Compared to the placebo group, patients treated with semaglutide were 24% less likely to experience this composite outcome.

Moreover, semaglutide met key secondary endpoints by reducing the likelihood of major cardiovascular events by 18% and slowing the overall progression of CKD. These comprehensive results suggest that semaglutide is highly effective at mitigating the risk of critical kidney-related outcomes and death from cardiovascular causes in patients with type 2 diabetes and CKD.

Semaglutide operates as a GLP-1 receptor agonist, mimicking the naturally occurring GLP-1 hormone and activating its associated receptor. This activation boosts insulin secretion from the pancreas in response to blood sugar levels, aiding in appetite suppression. The drug is commercially available under the names Ozempic for type 2 diabetes and Wegovy for chronic weight management. In March 2024, the FDA expanded Wegovy’s label to include the reduction of cardiovascular death, heart attack, and stroke risk in overweight and obese adults with cardiovascular disease.

The recent readout comes from the Phase III FLOW trial, a randomized, placebo-controlled, quadruple-masked study aimed at assessing the effects of semaglutide on renal impairment progression in diabetes patients with CKD. Novo Nordisk announced in October 2023 that it would terminate the FLOW trial ahead of schedule. This decision followed a recommendation from an independent data monitoring committee, which advised stopping the trial early due to meeting pre-specified efficacy criteria.

By March 2024, Novo Nordisk revealed headline data from the FLOW trial, which showed that semaglutide significantly reduced the risk of kidney disease progression, kidney death, and major adverse cardiovascular events by 24% compared to placebo. Additionally, the drug significantly improved both the CKD and cardiovascular components of the primary endpoint.

Novo Nordisk plans to pursue regulatory approval to expand semaglutide’s label to include coverage for CKD later this year. The consistent and comprehensive results from the Phase III FLOW trial underscore the potential of semaglutide as a crucial treatment option for patients grappling with type 2 diabetes and chronic kidney disease.