The most recent landmark trial, FLOW evaluated the potential role for the 1.0 mg dose of semaglutide on renal and CV endpoints among patients with type 2 diabetes and chronic kidney disease. The FLOW trial comes on the heels of several major trials assessing semaglutide in recent years, including the STEP trials, SELECT, STEP HFpEF, and STEP HFpEF DM.

      The trial included 3553 patients from 387 sites in 28 countries with an eGFR of 50 to 75 ml/min/1.73m2 of body-surface area and a urinary albumin-to-creatinine ratio (UACR) of greater than 300 and less than 5000 or an eGFR of 25 to less than 50 ml/min/1.73m2 and a UACR greater than 100 and less than 5000. Among the 3553 patients included in the trial, 1767 were randomized to semaglutide and 1766 were randomized to placebo therapy.The primary outcome for the trial was major kidney disease events, which investigators defined as dialysis, transplantation, an eGFR decline to less than 15 ml/min/1.73m2, a reduction of 50% or greater in eGFR from baseline, or death from kidney-related or cardiovascular causes.

      The pre-specified interim analysis revealed that semaglutide use was associated with a 24% relative risk reduction for the trial’s primary outcome of major kidney disease events compared to placebo (Hazard Ratio [HR], 0.76; 95% Confidence Interval [CI], 0.66 to 0.88; P = .0003). Further analysis showed that semaglutide use was also associated with a 21% reduction in risk relative to placebo therapy (HR, 0.79; 95% CI, 0.66 to 0.94). Additionally, analysis of death from cardiovascular causes revealed a 29% reduction in risk relative to placebo therapy (HR, 0.71; 95% CI, 0.56 to 0.89). The secondary outcomes also were in favour of the drug’s potential sustainable benefits. The use of semaglutide in people with type 2 diabetes and chronic kidney disease can lower the risk of major kidney outcomes and reduce the risk of cardiovascular events, cardiovascular death and all-cause death," Colhoun, the lead investigator opined. These benefits signify the extensive clinical impact saving kidneys, hearts and lives, for patients with type 2 diabetes and chronic kidney disease. The study got published in ‘The New England Journal of Medicine’.