Novo Nordisk's unstoppable semaglutide clears kidney disease trial early on positive efficacy

For a study weighing the injectable semaglutide in chronic kidney disease, an early end appears to give Novo Nordisk cause to celebrate.

Novo on Tuesday said it decided to stop its kidney outcomes trial FLOW on the advice of the study’s independent data monitoring committee. Semaglutide, which goes by the names Ozempic and Rybelsus in Type 2 diabetes, and Wegovy in obesity, hit certain pre-specified criteria to halt the trial early for efficacy, Novo said in a press release.

In light of the interim victory, Novo will begin powering down FLOW—though it will remain blinded to the data until the study’s formal completion. The company expects FLOW to read out during the first half of 2024.

FLOW, which kicked off in 2019, is comparing injectable semaglutide 1.0 mg with placebo as an add-on to standard of care. Novo has been hoping to prove semaglutide could repeat the success it’s had in diabetes and obesity in CKD. Specifically, the trial is looking at whether semaglutide can stall progression of CKD and curb the risk of death from kidney failure and cardiovascular issues. More than 3,500 patients are enrolled in the trial, Novo Nordisk said.

The trial’s composite primary endpoint includes five different components, including reduction in eGFR levels and whether patients needed dialysis or a kidney transplant, as well as death from kidney or cardiovascular disease in Type 2 diabetes patients with CKD.

Novo’s FLOW win comes as another class of diabetes meds, SGLT2 inhibitors, including AstraZeneca’s Farxiga and Eli Lilly and Boheringer Ingelheim's Jardiance, are making inroads in CKD.

Despite its huge success in diabetes and obesity, Novo still looks to push semaglutide beyond those bread-and-butter indications.

Back in August, Novo said semaglutide 2.4 mg—Wegovy’s dose—cut the risk of major adverse cardiovascular events by 20% versus placebo and standard of care in a large phase 3 trial among overweight or obesity patients with established cardiovascular disease.

Based on the trial win, Novo Nordisk said it expects to seek a label expansion to include the cardiovascular risk-reduction data in the U.S. and Europe this year. The company said the detailed results from the study, dubbed SELECT, will be presented at an upcoming scientific conference.

Still, it hasn’t all been smooth sailing for semaglutide. On top of recent manufacturing and supply hurdles, the drug was last month linked to a small risk of developing severe stomach problems, according to research conducted by the University of British Columbia published in the Journal of the American Medical Association.

The first-of-its-kind investigation highlighted a link between Novo’s popular GLP-1 products and the gastrointestinal conditions gastroparesis, pancreatitis and bowel obstruction. In the report, the investigators emphasized that the risk was very small.