Novo Nordisk Stops Semaglutide Kidney Outcome Trial Based On Early Signs Of Efficacy

Novo Nordisk A/S NVO has decided to stop the kidney outcomes trial FLOW based on a recommendation from the independent Data Monitoring Committee (DMC).

FLOW is a randomized, double-blind, parallel-group, placebo-controlled, superiority trial comparing injectable semaglutide 1.0 mg with placebo as an adjunct to standard of care on kidney outcomes to prevent progression of renal impairment and risk of renal and cardiovascular mortality in people with type 2 diabetes and chronic kidney disease. 

Also Read: Obesity Medication Insurance Coverage? Employers Embrace the Inclusion of Novo Nordisk's Wegovy in Health Coverage.

The FLOW trial was initiated in 2019, and over 3,500 people were enrolled.

The DMC concluded that the results from an interim analysis met certain pre-specified criteria for stopping the trial early for efficacy.

Novo Nordisk remains blinded to the results until trial completion. Novo Nordisk expects data readout during the first half year of 2024.

Citing Barclays analyst, Reuters noted that the company's decision affirmed that GLP-1 receptor agonists like Ozempic have "therapeutic benefits far beyond their original intended purpose."

A recent study published in JAMA raised concerns about the potential risks associated with popular weight loss and diabetes drugs like Novo Nordisk's Wegovy (semaglutide), Ozempic (semaglutide), and Saxenda (liraglutide), suggesting that these drugs, known as GLP-1s, may be linked to three rare but severe stomach conditions in non-diabetic patients.

Price Action: NVO shares are up 3.28% at $96.06 during the premarket session on the last check Wednesday.