Novo halts semaglutide kidney trial early for efficacy

Novo Nordisk will stop its phase 3 kidney outcomes trial early after results from an interim analysis met certain pre-specified criteria for efficacy.

The decision to stop the FLOW trial, which is comparing semaglutide versus placebo on the progression of renal impairment in people with type 2 diabetes and chronic kidney disease, is based on a recommendation from the trial's independent data monitoring committee. Initiated in 2019, the 3,534-person trial has been conducted in 28 countries at more than 400 investigator sites.

Already a blockbuster in both type 2 diabetes and obesity, Novo's semaglutide, branded Ozempic and Wegovy respectively, scored a major clinical win earlier this past summer when the GLP-1 analogue reduced the risk of major adverse cardiovascular events by 20% in adults with overweight or obesity in a large international trial.

Novo is also testing semaglutide as a once-daily treatment for Alzheimer’s disease as well as a once-weekly treatment for non-alcoholic steatohepatitis (NASH).