Recently, Novo Nordisk (NVO.US) announced the latest results of the Phase 3 clinical trial of its major therapy Ozempic (semaglutide, semaglutide) in FLOW at the European Kidney Association (ERA) conference.
The Zhitong Finance App learned that recently, Novo Nordisk (NVO.US) announced the latest results of the Phase 3 clinical trial of its major therapy Ozempic (semaglutide, simeglutide) in FLOW at the European Kidney Association (ERA) conference. According to the analysis, Ozempic reached the primary end point and all secondary endpoints of the test. Compared to placebo, Ozempic reduces the risk of major cardiovascular events by 18% and the risk of death from any cause by 20% in patients with chronic kidney disease (CKD) and type 2 diabetes. Notably, Novo Nordisk plans to submit regulatory applications for the Ozempic label extension to the US and EU in 2024.
According to information, the FLOW clinical trial is a randomized, double-blind, placebo-controlled clinical trial to examine the effects of subcutaneous injection of Ozempic at a dose of 1.0 mg compared with placebo as an adjuvant treatment as standard treatment to prevent the progression of kidney damage and the risk of renal and cardiovascular death in patients with CKD and type 2 diabetes.
Ozempic is a GLP-1 receptor agonist that stimulates insulin production. The weekly injectable form of this treatment was approved by the FDA in 2017 to treat type 2 diabetes. It was also approved by the FDA again in January 2020 to reduce the risk of major adverse cardiovascular events (MACE), such as heart attack, stroke, or death in adult patients with type 2 diabetes and known heart disease.
According to the ClinicalTrials.gov website, Novo Nordisk will also launch a phase 2 trial to examine the effects of three drugs, including simeglutide, on liver function, degree of liver fibrosis, and alcohol intake in patients with alcohol-related liver disease. According to industry media STAT, this may be the first time that the company has examined the effects of GLP-1 drugs on addiction.
According to World Health Organization (WHO) estimates, about 422 million people worldwide have diabetes. This disease is often caused by the body's inability to produce enough insulin or to properly use insulin synthesized by the body. As a result, the ability of these patients to regulate blood sugar will be greatly affected. In addition, people with type 2 diabetes also have a higher risk of developing other diseases. For example, type 2 diabetics have a 2-4 times higher risk of cardiovascular disease than healthy people, and about 40% of type 2 diabetics have CKD.