Dannish healthcare company Novo Nordisk A/S (NVO) said it has decided to stop the once-weekly injectable semaglutide kidney outcomes trial FLOW at interim, as per a recommendation from the independent Data Monitoring Committee or DMC. The results from an interim analysis met certain pre-specified criteria for stopping the trial early for efficacy, it said.
Shares of Novo Nordisk were gaining around 3 percent in Denmark trading as well as in pre-market activity on the NYSE.
Once-weekly subcutaneous semaglutide is approved in 0.5, 1.0 and 2.0 mg doses under the brand name Ozempic and indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. It is also indicated to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease.
The trial FLOW, which was initiated in 2019, evaluates the effect of semaglutide versus placebo on the progression of renal impairment in people with type 2 diabetes and chronic kidney disease.
The trial protocol provides for an interim analysis when a prespecified number of primary endpoint events has occurred.
The company will initiate the process of closing the trial. To protect the integrity of the trial, Novo Nordisk said it remains blinded to the results until trial completion. Novo Nordisk expects that FLOW will read out during the first half year of 2024.
In Copenhagen, Novo Nordisk shares were trading at DKK 670.10, up 3.08 percent. In pre-market activity on the NYSE, the shares were trading at $95.40, up 2.57 percent.
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