Denmark-based pharmaceutical giant Novo Nordisk (NYSE: NVO) has decided to discontinue a Phase III global study evaluating the impact of the GLP-1 receptor agonist Ozempic (semaglutide) on the progression of renal impairment in individuals with type 2 diabetes (T2D) and chronic kidney disease (CKD). The decision was recommended by an independent data monitoring committee (DMC) after analyzing interim efficacy data, with the final results still blinded and expected in the first half of 2024.
Background on Ozempic and Its Indications
Ozempic, a subcutaneous injection, is already approved for glycemic control in patients with T2D and for reducing the risk of major cardiovascular events in T2D patients with established cardiovascular disease (CVD). The drug’s potential benefits in managing renal impairment in this patient population were under investigation in the halted study.
Novo Nordisk’s Broad Semaglutide Program
According to Fineline Info & Tech analysis, the halted study on CKD is just one of several indications being explored in Novo Nordisk’s semaglutide program. Ongoing trials are also examining the effects of semaglutide in non-alcoholic steatohepatitis (NASH), Alzheimer’s Disease, diabetic retinopathy, peripheral arterial disease (PAD), heart failure with preserved ejection fraction (HFpEF), and obesity. Additionally, the company is developing an oral formulation of semaglutide for the treatment of T2D, obesity, and CVD.
Conclusion
The decision to stop the Phase III study on Ozempic’s effects on renal impairment in T2D and CKD patients reflects Novo Nordisk’s commitment to rigorous scientific evaluation and patient safety. While the study’s suspension may impact the drug’s potential indications, it does not detract from the breadth of Novo Nordisk’s ongoing research into the versatile applications of semaglutide.-Fineline Info & Tech
