Novo Nordisk Halts Phase 3 FLOW Trial for Semaglutide in Diabetic Kidney Disease Due to Positive Interim Efficacy Results

Intelligent Finance APP learned that Danish pharmaceutical manufacturer Novo Nordisk (NVO.US) announced on Tuesday that it would halt a large Phase III trial evaluating the efficacy of injectable semaglutide in treating renal failure in patients with type 2 diabetes and chronic kidney disease.

The decision to stop the study named FLOW was based on the recommendation of an independent Data Monitoring Committee (DMC).

The DMC concluded that the interim analysis of the trial results showed that the efficacy outcomes met the pre-specified criteria sufficiently to warrant ending the study.

FLOW is a randomized, double-blind study comparing injectable semaglutide with placebo as an adjunct to standard care for the treatment of renal impairment in patients with type 2 diabetes and chronic kidney disease.

The trial was initiated in 2019 and has recruited over 3,500 people.

Novo Nordisk said in a statement: "Based on the decision to suspend the trial, the process to terminate the trial will be initiated." "To protect the integrity of the trial, Novo Nordisk will keep the results confidential until the trial is completed. Novo Nordisk expects FLOW to conclude in the first half of 2024."