Ozempic's Phase III Success for Cardiometabolic Indications

Novo Nordisk has recently announced the results of the Phase III FLOW trial, which highlight the positive impact of its diabetes medication, Ozempic, on kidney and cardiometabolic health. The trial focused on patients with type 2 diabetes and chronic kidney disease (CKD), demonstrating a significant reduction in the risk of kidney disease progression and major adverse cardiovascular events.

The study showed that Ozempic, containing semaglutide, achieved its primary endpoint, leading to a 24% decrease in the combined risk of kidney disease worsening, serious heart problems, and kidney-related deaths, compared to a placebo. The drug also showed benefits across all five individual components of the composite outcome, which contributed to the overall risk reduction. Moreover, Ozempic was well-tolerated by the participants, aligning with previous findings.

Novo Nordisk's executive vice president, Martin Holst Lange, expressed excitement over the results, suggesting that semaglutide could become a pioneering GLP-1 treatment for individuals with both type 2 diabetes and CKD. It is noteworthy that a considerable percentage of type 2 diabetes patients also grapple with CKD.

With the successful trial outcomes, Novo Nordisk is considering expanding the indications for Ozempic and is preparing to submit regulatory applications in the U.S. and E.U. for the same in 2024. The company also plans to present the FLOW trial data at a scientific conference later this year.

The FLOW trial was a randomized, double-blinded study that included over 3,500 participants globally. Eligibility was based on confirmed type 2 diabetes and kidney impairment, as determined by a specific test. Participants were randomly assigned to receive either a placebo or a 1-mg dose of semaglutide in addition to standard care.

The trial had previously been halted early in October 2023 after an interim analysis by an independent committee found that the study had met certain criteria for efficacy, leading to an early conclusion.

Novo Nordisk's pursuit to expand the use of semaglutide into the cardiometabolic field is ongoing. In August 2023, data from the Phase III SELECT trial indicated that a higher dose of semaglutide could reduce the frequency of major adverse cardiovascular events in overweight and obese adults without diabetes. The company is also investigating the potential of semaglutide in treating metabolic dysfunction-associated steatohepatitis, with Phase II results previously published in a renowned medical journal showing a higher rate of disease resolution compared to a placebo. However, the drug did not significantly improve fibrosis outcomes.