A trial by Novo Nordisk of its GLP-1 blockbuster Ozempic (semaglutide) on diabetes and kidney disease patients was successful enough that it was halted for efficacy five months ago at the interim stage after a recommendation from the Independent Data Monitoring Committee.
But Tuesday, when Novo reported headline results of the phase 3 FLOW study, they didn’t satisfy investors as the price of the Danish company’s shares dropped 3%. Such are the outsized expectations of the juggernaut treatment which moderates blood sugar.
The trial of 3,533 people with type 2 diabetes and chronic kidney disease (CKD) found that Ozempic reduced the risk of kidney disease progression and the risk of kidney and cardiovascular death by 24%. That didn’t measure up, however, to the 30% figure analysts anticipated.
The study assessed semaglutide versus placebo as an add-on treatment to standard of care for prevention of kidney impairment. The primary endpoint took into account five measurements of the progression of CKD and the risk of death from kidney and cardiovascular outcomes. Both the CKD and cardiovascular components contributed to the risk reduction, Novo said.
“Approximately 40% of people with type 2 diabetes have (CKD), so the positive results from FLOW demonstrate the potential for semaglutide to become the first GLP-1 treatment option for people living with type 2 diabetes and (CKD),” Martin Holst Lange, Novo’s EVP for development, said in a release.
The company will file for regulatory approvals in the United States and Europe this year to expand Ozempic's label, Novo said.
The results come on top of positive data from the 3 SELECT trial, which showed that Novo’s semaglutide obesity drug Wegovy cut the risk of a non-fatal heart attack by 28% and the risk of progression of CKD and renal death by 22%.
That study—which included more than 17,000 nondiabetic and overweight patients with established cardiovascular disease—also showed Wegovy reduced the risk of heart-related death by 15% and the risk of death by any cause by 19%. It also slashed the risk of developing diabetes by 73%.
Wegovy also has excelled in a phase 3 study on patients with obesity and heart failure with preserved ejection fraction (HFpEF), reducing symptoms and improving their mobility.
Novo has made a huge splash with its semaglutide drugs. While Ozempic generated sales of 95.7 billion Danish kroner ($13.9 billion) in 2023, Wegovy pulled in 31.6 billion Danish kroner ($4.5 billion). The two treatments combined to account for 55% of Novo’s revenue, which increased by 31% in 2023 to 232 billion Danish kroner ($33.7 billion).
In diabetes and obesity, Eli Lilly is competing with Novo with its GLP-1/GIP drug tirzepatide. The company has yet to provide any cardiovascular or kidney disease data for its drugs Mounjaro and Zepbound but there is belief from some obesity specialists that Lilly's treatments will provide similar benefits.