The ability of Novo Nordisk’s semaglutide to lower blood sugar and reduce weight has made it a blockbuster seller for addressing type 2 diabetes and obesity. Now it looks like the drug can treat chronic kidney disease.
A clinical trial testing semaglutide’s effect on the kidneys has been stopped early after an interim analysis found that the drug met prespecified criteria for showing efficacy. The recommendation to stop the study came from an independent data monitoring committee. Novo Nordisk said late Tuesday that it remains blinded to the data, which have not been released. The company said it will start the process of closing the trial and it expects data will become available during the first half of 2024.
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Semaglutide is a peptide designed to be an analog for the GLP-1 hormone found in our bodies. The drug binds to and activates the GLP-1 receptor, stimulating secretion of the blood sugar-regulating hormone, insulin. Semaglutide is the main pharmaceutical ingredient in Novo Nordisk’s type 2 diabetes drug Ozempic and the weight loss drug Wegovy.
Chronic kidney disease does not have any FDA-approved therapies, but diabetes drugs and blood pressure medications are among the products prescribed to manage the condition. To assess semaglutide’s effect on the kidneys, Novo Nordisk tested the drug in a double blind, placebo-controlled study that enrolled people with type 2 diabetes and chronic kidney disease. The drug was evaluated as an adjunct to standard of care treatments. Participants in the 61-week study administered semaglutide once weekly via an injection pen.
The main study goal was to measure the time to first occurrence of persistent 50% or greater decline in eGFR, a measure of kidney function; the start of dialysis or a kidney transplant; or death from kidney disease or cardiovascular disease. Secondary goals include measuring the annual rate of change in eGFR and death from any cause.
Novo Nordisk began the chronic kidney disease clinical trial in 2019. The study enrolled 3,534 people in 28 countries at more than 400 sites. According to the clinical trial protocol, the interim analysis was not set for a particular point in time. Rather, the analysis was triggered when a prespecified number of primary endpoint events occurred.
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Ozempic, launched in 2018, is Novo Nordisk’s top-selling product, accounting for 59.8 billion Danish kroner (about $8.5 billion) in sales last year, according to the company’s annual report. Wegovy, which offers a higher dose of semaglutide than Ozempic, landed its FDA approval in 2021. Novo Nordisk has been conducting additional clinical trials that could support expanding semaglutide’s uses, and in turn, the drug’s revenue potential. In August, Novo Nordisk reported clinical data showing Wegovy lowered cardiovascular risks by 20%. Based on those results, the company said it plans to seek regulatory approvals in this indication in the U.S. and Europe.
However, semaglutide does come with risks. Acute kidney injury and severe gastrointestinal reactions are among the potential complications listed on the drug’s label. In Ozempic’s clinical trials, adverse gut reactions—nausea, vomiting, and diarrhea—were more common in the study drug group compared to the placebo arm. Last week, the Journal of the American Medical Association published results from a study that showed use of a GLP-1 agonists for weight loss was associated with a higher risk of pancreatitis, bowel obstruction, and gastroparesis.
“Given the wide use of these drugs, these adverse events, although rare, must be considered by patients who are contemplating using the drugs for weight loss because the risk-benefit calculus for this group might differ from that of those who use them for diabetes,” the study authors wrote.
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