The power of Novo Nordisk’s semaglutide to decrease blood sugar and scale back weight has made it a blockbuster vendor for addressing sort 2 diabetes and weight problems. Now it seems to be just like the drug can deal with power kidney illness.
A medical trial testing semaglutide’s impact on the kidneys has been stopped early after an interim evaluation discovered that the drug met prespecified standards for displaying efficacy. The advice to cease the research got here from an unbiased information monitoring committee. Novo Nordisk stated late Tuesday that it stays blinded to the info, which haven’t been launched. The corporate stated it should begin the method of closing the trial and it expects information will grow to be obtainable in the course of the first half of 2024.
Semaglutide is a peptide designed to be an analog for the GLP-1 hormone present in our our bodies. The drug binds to and prompts the GLP-1 receptor, stimulating secretion of the blood sugar-regulating hormone, insulin. Semaglutide is the primary pharmaceutical ingredient in Novo Nordisk’s sort 2 diabetes drug Ozempic and the burden loss drug Wegovy.
To evaluate semaglutide’s impact on the kidneys, Novo Nordisk examined the drug in a double blind, placebo managed research that enrolled individuals with sort 2 diabetes and power kidney illness. The drug was evaluated as an adjunct to straightforward of care remedies. Members within the 61-week research administered semaglutide as soon as weekly by way of an injection pen.
The principle research purpose was to measure the time to first incidence of persistent 50% or better decline in eGFR, a measure of kidney perform; the beginning of dialysis or a kidney transplant; or demise from kidney illness or heart problems. Secondary targets embrace measuring the annual fee of change in eGFR and demise from any trigger.
Novo Nordisk started the power kidney illness medical trial in 2019. The research enrolled 3,534 individuals in 28 nations at greater than 400 websites. In accordance with the medical trial protocol, the interim evaluation was not set for a selected cut-off date. Reasonably, the evaluation was triggered when a prespecified variety of main endpoint occasions occurred.
Ozempic, launched in 2018, is Novo Nordisk’s top-selling product, accounting for 59.8 billion Danish kroner (about $8.5 billion) in gross sales final yr, based on the corporate’s annual report. Wegovy, which presents the next dose of semaglutide than Ozempic, landed its FDA approval in 2021. Novo Nordisk has been conducting extra medical trials that would assist increasing semaglutide’s makes use of, and in flip, the drug’s income potential. In August, Novo Nordisk reported medical information displaying Wegovy lowered cardiovascular dangers by 20%. Based mostly on these outcomes, the corporate stated it plans to hunt regulatory approvals on this indication within the U.S. and Europe.
Nonetheless, semaglutide does include dangers. Acute kidney damage and extreme gastrointestinal reactions are among the many potential issues listed on the drug’s label. In Ozempic’s medical trials, opposed intestine reactions—nausea, vomiting, and diarrhea—had been extra widespread within the research drug group in comparison with the placebo arm. Final week, the Journal of the American Medical Affiliation printed outcomes from a research that confirmed use of a GLP-1 agonists for weight reduction was related to the next danger of pancreatitis, bowel obstruction, and gastroparesis.
“Given the large use of those medicine, these opposed occasions, though uncommon, should be thought-about by sufferers who’re considering utilizing the medicine for weight reduction as a result of the risk-benefit calculus for this group would possibly differ from that of those that use them for diabetes,” the research authors wrote.
Photograph: peterschreiber.media, Getty Photos
