Novo Nordisk A.S. said Tuesday a five-year trial of its Ozempic weight-loss drug helped reduce the risk of kidney disease-related events in people with Type 2 diabetes by 24%.
The Danish company disclosed the results of the trial called Flow after it was halted on the recommendation of an independent monitoring committee on Oct. 10, 2023, after showing successful results.
The trial compared injectable semaglutide, which the company markets as Ozempic, with placebo to evaluate its efficacy in treating people with Type 2 diabetes and chronic kidney disease.
Some 3,533 patients participated in the trial, which showed a statistically significant and superior reduction in kidney disease progression, major adverse cardiovascular events and death using a 1.0 mg dose.
“Further, superiority of semaglutide 1 mg vs placebo was confirmed for the confirmatory secondary endpoints,” the company said in a statement.
Semaglutide proved to be safe and well-tolerated in the trial, in line with earlier 1.0 mg trials.
“Approximately 40% of people with Type 2 diabetes have chronic kidney disease, 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 chronic kidney disease,” said Martin Holst Lange, executive vice president for development at Novo Nordisk
NVO,
NOVO.B,
The company is planning to file for regulatory approval of a label expansion for Ozempic in the U.S. and European Union in 2024, and will publish detailed results from Flow at a scientific conference.
GLP-1 refers to the new class of drugs used for diabetes and weight loss that have become highly popular and even led to shortages. GLP stands for glucagon-like peptide. The drugs work by mimicking the effect of GLP-1, a gut hormone that can help control blood-sugar levels and reduce appetite.
The already-popular weight-loss drugs are expected to grow to an audience of 24 million, or nearly 7% of the overall U.S. population, in the next decade, according to a Morgan Stanley note from August.
Read now: As Ozempic/Wegovy frenzy continues, Morgan Stanley lifts forecasts for weight-loss drugs to $77 billion
Kidney dialysis services companies’ stocks rose early Tuesday, DaVita Inc.,
DVA,
was up 6.6% premarket, while the ADRs of Germany’s Fresenius AG
FMS,
were up 9%.
Boston Scientific Corp.
BSX,
which makes medical devices for kidney issues, was up 1%.
Novo Nordisk’s U.S.-listed stock was up 0.7%.
Read also: Viking Therapeutics’ promising weight-loss drug data makes the company a takeover target
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