Ole Schwander
Danish drugmaker Novo Nordisk (NVO) on Tuesday said it would stop its large phase 3 trial assessing injectable semaglutide for the treatment of kidney failure in people with type 2 diabetes and chronic kidney disease.
The decision to stop the study, called FLOW, was based on a recommendation from an independent data monitoring committee (DMC).
The DMC concluded that an interim analysis of the trial results showed efficacy results that met enough pre-specified criteria to end the study.
FLOW was designed as a randomized, double-blind study comparing injectable semaglutide with a placebo as an adjunct to standard of care for treating renal impairment in people with type 2 diabetes and chronic kidney disease.
The trial was initiated in 2019 and has enrolled more than 3.5K people.
“Based on the decision to stop the trial at interim, the process of closing the trial will be initiated,” Novo Nordisk (NVO) said in a statement.
“To protect the integrity of the trial, Novo Nordisk (NVO) remains blinded to the results until trial completion. Novo Nordisk (NVO) expects that FLOW will read out during the first half year of 2024,” the company added.
NVO stock was up 2.2% to $95.05 after hours.