Novo’s Ozempic Poised for Cardiometabolic Expansion with New Phase III Data

Novo Nordisk Building

Pictured: Novo Nordisk's corporate headquarters in Denmark/iStock, Ole Schwander

Novo Nordisk on Tuesday released headline data from the Phase III FLOW trial demonstrating that its top-selling diabetes drug Ozempic (semaglutide) can significantly preserve kidney and cardiometabolic health in patients with type 2 diabetes and chronic kidney disease.

The Danish drugmaker reported that semaglutide met the composite primary endpoint of FLOW, leading to a significant 24% reduction in the risk of kidney disease progression, major adverse cardiovascular events (MACE) and kidney death versus placebo.

Semaglutide exerted its beneficial effects on the five individual cardiovascular and chronic kidney disease (CKD) components of the composite outcome, all of which contributed to the overall risk reduction in the primary endpoint, according to Novo. The GLP-1 receptor agonist also outperformed placebo in terms of FLOW’s confirmatory secondary efficacy metrics.

In terms of safety, semaglutide appeared to be well-tolerated in the study, consistent with what had been previously reported.

Martin Holst Lange, executive vice president for development and Novo, said in a statement that the company is “very excited” about these findings, which point to the potential of semaglutide “to become the first GLP-1 treatment option for people living with type 2 diabetes and chronic kidney disease.” Around 40% of type 2 diabetes patients also struggle with CKD, according to Lange.

With these data in hand, Novo is eyeing a label expansion for Ozempic and is planning to file regulatory submissions in the U.S. and E.U. in 2024. The company will also present data from FLOW at a scientific congress this year.

FLOW is a randomized and double-blinded kidney outcomes trial that enrolled more than 3,500 patients worldwide. Only those with confirmed type 2 diabetes mellitus and renal impairment, as determined by a serum creatinine-based eGFR test, were eligible to participate. Patients were given either placebo or a 1-mg dose of semaglutide as an adjunct to standard of care.

Novo previously announced that FLOW had aced its primary goal. In October 2023, the Danish pharma ended the study ahead of schedule following the recommendation of an independent data monitoring committee, which in an interim analysis found that FLOW’s data “met certain pre-specified criteria for stopping the trial early for efficacy.”

The FLOW readout on Tuesday also continues Novo’s quest to push semaglutide into the cardiometabolic space and add to its indications beyond diabetes and obesity. In August 2023, the pharma released data from the Phase III SELECT trial showing that a 2.4-mg dose of semaglutide could cut MACE frequency by 20% versus placebo in overweight and obese adults without diabetes.

Novo is also studying semaglutide in metabolic dysfunction-associated steatohepatitis. In 2021, Phase II data were published in The New England Journal of Medicine demonstrating a significantly higher rate of disease resolution relative to placebo. However, semaglutide was unable to elicit significant fibrosis benefits.

Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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