Novo Nordisk is ending its Phase III FLOW trial ahead of schedule after an interim analysis of the kidney outcomes study of semaglutide found a very high likelihood of study success. FLOW is a large randomised, double-blinded and placebo-controlled superiority trial, was assessing the effects of Novo’s GLP-1 agonist semaglutide on the progression of renal impairment and on the risk of renal and cardiovascular mortality in patients with type 2 diabetes and chronic kidney disease (CKD).
The study enrolled more than 3,500 patients worldwide and administered semaglutide as an adjunct to standard of care. FLOW’s protocol allowed for an interim analysis once a specific and pre-determined number of primary endpoint events had already occurred. At this interim analysis, an independent Data Monitoring Committee recommended to stop FLOW early because its data “met certain pre-specified criteria for stopping the trial early for efficacy.”
To preserve the integrity of the trial, the company will stay blinded to its data while it closes out the study. The company expects to share FLOW’s readout in the first half of 2024.