Novo Nordisk will halt the phase 3b FLOW trial, which investigated the effects of once-weekly injectable semaglutide on kidney outcomes in individuals with type 2 diabetes (T2D) and chronic kidney disease (CKD).
The company reached the decision following the recommendation of the independent Data Monitoring Committee (DMC), following an interim analysis that met pre-specified criteria for stopping the trial early for efficacy. The company noted that it would maintain the integrity of the trial data, blinding to the results until the trial’s completion. It plans on announcing results in the first half of 2024.
The FLOW trial was a randomized, double-blind, parallel-group, multinational study that enrolled 3,534 participants across more than 400 investigator sites in 28 countries. The key objective of the trial was to determine the time to first kidney failure, persistent reduction in estimated glomerular filtration rate (eGFR), or death from kidney or cardiovascular causes.
The study, which began in 2019, assessed injectable semaglutide 1.0 mg versus a placebo as an additional treatment to the standard of care. The aim of the trial was to determine if semaglutide can delay the progression of CKD and reduce the risk of death from kidney failure and cardiovascular complications. The trial’s primary composite endpoint included five distinct components, including a decrease in eGFR levels, the need for dialysis or a kidney transplant, and death from kidney or cardiovascular disease in patients with type 2 diabetes and CKD.
In addition to GLP drugs like semaglutide, another class of diabetes medications, including AstraZeneca’s Farxiga and Eli Lilly and Boehringer Ingelheim’s Jardiance, are emerging as potential CKD therapies.
Semaglutide, marketed under the brand name Ozempic, is a glucagon-like peptide-1 receptor agonist (GLP-1RA) indicated as an adjunct to diet and exercise for improving glycemic control in adults with type 2 diabetes and for reducing the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.
FDA approved semaglutide-based weekly injectable Wegovy to treat adults with obesity in 2021. It extended approval to adolescents 12 years and older in 2022.
Novo Nordisk aims to more than triple sales of its obesity drugs by 2025, which includes Wegovy among others. In 2022, the company projected that obesity drugs sales will exceed more than 25 billion Danish kroner, or about $3.7 billion by 2025.
Filed Under: clinical trials, Drug Discovery, Nephrology/urology, Regulatory affairs