Novo Nordisk sees positive results in impact of semaglutide on kidney function, ends trial
Click Here to Manage Email Alerts
Key takeaways:
- Novo Nordisk has ended a trial evaluating the impact of semaglutide on kidney function.
- The key objective of the trial was to demonstrate delay in progression of CKD and to lower the risk of mortality.
Novo Nordisk has ended a clinical trial evaluating the impact of semaglutide on kidney function after the results from an interim analysis met certain pre-specified criteria, according to a company press release.
To protect the integrity of the trial, Novo Nordisk will remain blinded to the results until the trial is completed, likely during the first half of 2024, according to the release.
The FLOW trial (Effect of semaglutide vs. placebo on the progression of renal impairment in people with type 2 diabetes and chronic kidney disease), is a randomized, double-blind, parallel-group, placebo-controlled, superiority trial initiated in 2019 comparing the use of a weekly 1 mg injection of semaglutide with placebo “for prevention of progression of renal impairment and risk of renal and cardiovascular mortality in people with type 2 diabetes and chronic kidney disease (CKD),” according to the release.
There were 3,534 patients enrolled in the FLOW trial, which was conducted in 28 countries at more than 400 investigator sites, according to the release.
Researchers looked at the following five components among patients in the trial when evaluating the impact of semaglutide on kidney function:
- onset of persistent 50% or greater reduction in eGFR, according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, compared with baseline;
- onset of persistent eGFR (CKD-EPI) less than 15 mL/min/1.73 m2;
- initiation of chronic kidney replacement therapy (dialysis or kidney transplantation);
- death from kidney disease; or
- death from CVD in patients with type 2 diabetes and CKD.
Key secondary endpoints in the trial include annual rate of change in eGFR (CKD-EPI), major adverse cardiovascular events (non-fatal myocardial infarction, non-fatal stroke and cardiovascular death) and all-cause death.
Read more about
Click Here to Manage Email Alerts