｜Edited by the Content Team of Zhong Peptide BiochemicalOn March 5, 2024, Novo Nordisk announced the main results of the FLOW renal outcomes trial. The study was recommended to be terminated early on October 10, 2023, by the independent data monitoring committee due to outstanding efficacy.
FLOW Clinical Trial is a randomized, double-blind, placebo-controlled clinical trial designed to examine the effects of 1.0 mg injectable semaglutide compared with placebo as an adjunct to standard care in preventing the progression of kidney damage and reducing the risk of renal and cardiovascular death in patients with type 2 diabetes and CKD. The trial enrolled 3,533 patients with type 2 diabetes and CKD. The primary endpoint is a composite endpoint consisting of multiple components, including: time to a sustained ≥50% decline in estimated glomerular filtration rate (eGFR) from baseline; time to eGFR dropping below <15 mL/min/1.73 m²; initiation of chronic kidney replacement therapy (dialysis or kidney transplantation); and death due to kidney disease or cardiovascular disease in patients with type 2 diabetes and chronic kidney disease. Key secondary endpoints include the annual rate of change in eGFR, major adverse cardiovascular events (non-fatal myocardial infarction, non-fatal stroke, cardiovascular death), and all-cause mortality.Results showed that, compared with the placebo group, the risk of kidney disease progression as well as cardiovascular and renal death in the semaglutide group was reduced by 24%, reaching the superiority endpoint. In addition, the study also met the superiority criteria for the confirmatory secondary endpoints. In terms of safety, semaglutide demonstrated good safety and tolerability, consistent with previous studies.Novo Nordisk's Executive Vice President of Development, Martin Holst Lange, stated: "We are very excited about the results of the FLOW study, which demonstrate that 1.0mg semaglutide can reduce the risk of kidney disease progression. Approximately 40% of patients with type 2 diabetes develop chronic kidney disease, so the positive results of the FLOW study indicate that semaglutide has the potential to become the first treatment for patients with type 2 diabetes and chronic kidney disease."GLP-1Treatment options."Semaglutide is a GLP-1 receptor agonist that stimulates insulin production, inhibits glucagon secretion, and reduces appetite and food intake. Semaglutide was initially developed as a treatment for type 2 diabetes.ApprovedLaunched (Brand Name: Ozempic), in view of its significant effect on weight loss, the FDA in June 2021ApprovalIt is used to treat ordinary obese patients (trade name: Wegovy), which is the first new drug approved by the US FDA for controlling common obesity or overweight since 2014. The drug was subsequently approved by the EU for the treatment of obesity indications later in the same year.AboutNovo Nordisk
Novo Nordisk, founded in 1923, is a global leading biopharmaceutical company headquartered in Copenhagen, the capital of Denmark. Our goal is to drive change to defeat diabetes and other serious chronic diseases such as obesity, rare blood disorders, and endocrine disorders. To achieve this goal, we lead scientific breakthroughs, expand the accessibility of our medicines, and are committed to preventing and ultimately curing diseases. Novo Nordisk has approximately 47,000 employees across 80 countries and regions worldwide, providing products and services to more than 168 countries and regions globally.
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