The power of Novo Nordisk’s semaglutide to decrease blood sugar and cut back weight has made it a blockbuster vendor for addressing sort 2 diabetes and weight problems. Now it seems just like the drug can deal with persistent 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 examine got here from an impartial information monitoring committee. Novo Nordisk mentioned late Tuesday that it stays blinded to the info, which haven’t been launched. The corporate mentioned it’s going to begin the method of closing the trial and it expects information will develop into obtainable throughout 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 load loss drug Wegovy.
To evaluate semaglutide’s impact on the kidneys, Novo Nordisk examined the drug in a double blind, placebo managed examine that enrolled folks with sort 2 diabetes and persistent kidney illness. The drug was evaluated as an adjunct to straightforward of care therapies. Contributors within the 61-week examine administered semaglutide as soon as weekly through an injection pen.
The primary examine objective was to measure the time to first incidence of persistent 50% or larger decline in eGFR, a measure of kidney operate; the beginning of dialysis or a kidney transplant; or loss of life from kidney illness or heart problems. Secondary targets embody measuring the annual fee of change in eGFR and loss of life from any trigger.
Novo Nordisk started the persistent kidney illness medical trial in 2019. The examine enrolled 3,534 folks in 28 nations at greater than 400 websites. In line with the medical trial protocol, the interim evaluation was not set for a specific time limit. Fairly, the evaluation was triggered when a prespecified variety of major 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, in response to 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 further medical trials that might help 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%. Primarily based on these outcomes, the corporate mentioned it plans to hunt regulatory approvals on this indication within the U.S. and Europe.
Nonetheless, semaglutide does include dangers. Acute kidney harm and extreme gastrointestinal reactions are among the many potential issues listed on the drug’s label. In Ozempic’s medical trials, hostile intestine reactions—nausea, vomiting, and diarrhea—had been extra frequent within the examine drug group in comparison with the placebo arm. Final week, the Journal of the American Medical Affiliation published results from a examine that confirmed use of a GLP-1 agonists for weight reduction was related to the next threat of pancreatitis, bowel obstruction, and gastroparesis.
“Given the huge use of those medication, these hostile occasions, though uncommon, have to be thought-about by sufferers who’re considering utilizing the medication 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 examine authors wrote.
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