Novo Nordisk will stop a large clinical trial testing its diabetes drug Ozempic after an early look at the data found treatment had a kidney benefit, the company said Tuesday.
The study findings could strengthen the case for using Ozempic to control blood sugar and reduce weight in people with Type 2 diabetes, about one-third of whom develop chronic kidney disease because of damage to blood vessels and filtering cells in the organ. The once-weekly injection already has Food and Drug Administration approval as a preventive treatment for heart attacks and strokes, a major cause of death and hospitalization in people with Type 2 diabetes.
The positive data also help position Ozempic in a battle for market share with Eli Lilly’s newest treatment Mounjaro, which has won approval to treat diabetes but hasn’t completed the necessary clinical trials to demonstrate whether it helps delay kidney disease or prevent cardiovascular events.
The rivalry between the two leading metabolic disease drugmakers is likely to intensify as Lilly is seeking approval for Mounjaro as a weight loss drug, to compete with Novo’s product Wegovy, which has the same active ingredient, semaglutide, as Ozempic.
Denmark-based Novo didn’t release detailed data from the trial, called FLOW, indicating that results will remain “blinded” until the study is complete. A full readout will occur in the first half of 2024, the company said in a release.
The trial, which began in 2019, enrolled 3,500 people with diabetes and kidney disease and assigned them to either Ozempic or a placebo for up to a planned five years. Researchers followed the enrollees to detect a drop in their kidney filtering rates, end-stage kidney disease or death from either kidney disease or cardiovascular disease.
The decision to end the trial early came from an independent data monitoring panel, which found that Ozempic lowered the risk of those kidney-related conditions by enough to meet a pre-planned statistical criteria.
Based on the trial’s design, Ozempic needed to reduce the absolute risk of one of those kidney-related conditions by at least 3.5% when compared to placebo, or a relative risk reduction of around 16.5%, Akash Tewari, a Jefferies analyst who covers Lilly, wrote in a note to clients.
Tewari said that the trial’s findings won’t increase the number of patients eligible to receive Ozempic. But Tewari added: “It makes the rationale to use in that population even stronger.”
Boehringer Ingelheim and Lilly’s diabetes pill Jardiance,which works differently than Ozempic, recently won Food and Drug Administration approval as a kidney disease drug in people without diabetes. The clearance was based on data indicating that it reduced the relative risk of poor kidney outcomes by about 28%.
