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  • Novo Nordisk announced the results of a clinical trial showing its blockbuster drug Ozempic lowered the risk of kidney-disease related events in people with diabetes and chronic kidney disease.
  • The study, which has yet to be published, suggests that semaglutide had a 24% risk reduction in kidney- and cardiovascular-related mortality.
  • The findings add to evidence showing this class of GLP-1 drugs could help treat other health conditions aside from obesity and type 2 diabetes.

Around 1 in 3 people with diabetes have chronic kidney disease caused when high blood sugar levels due to diabetes can damage blood vessels in the kidneys, impairing function over time.

Now, a new clinical trial by Novo Nordisk shows that semaglutide, known by the brand name Ozempic, can cut the risk of kidney disease-related events in people with type 2 diabetes (T2D) and chronic kidney disease (CKD).

The results of the FLOW trial add to growing evidence showing that semaglutide, a popular type of injectable GLP-1 drug, can have other health benefits aside from treating type 2 diabetes and obesity.

While the full study has not yet been published, Novo Nordisk said it will present the data at a scientific conference sometime this year.

The company will also file for regulatory approvals of a label expansion for Ozempic to treat other health conditions in the United States and Europe in 2024. It is also working to broaden insurance coverage for its other semaglutide drug, Wegovy.

“We are very excited about the results from FLOW showing that semaglutide 1.0 mg reduces the risk of kidney disease progression,” said Martin Holst Lange, executive vice president for development at Novo Nordisk, in a news release on March 5.

“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.”

Novo Nordisk’s FLOW trial began in 2019 and ended in October 2023, a year earlier than expected due to efficacy.

The double-blind, placebo-controlled trial compared injectable semaglutide (1.0 mg) with a placebo as an adjunct treatment to standard of care for chronic kidney disease.

The trial followed 3,533 people in 28 countries with type 2 diabetes and moderate to severe kidney disease.

The results demonstrate delayed progression of CKD in the semaglutide group with a 24% reduced risk of death from kidney- and cardiovascular-related complications compared to the placebo group.

Dr. Pouya Shafipour, board certified family and obesity medicine physician at Providence Saint John’s Health Center in Santa Monica, CA, told Healthline he was not surprised by the results of the trial.

Shafipour noted recent positive data showing that GLP-1 drugs like Ozempic and Wegovy benefit kidney and heart function in people with type 2 diabetes.

“I’ve been prescribing this class of drugs for a few years, and I’ve seen great improvements of diabetes control — they’re really helping with addictive eating behaviors, which helps with weight loss and helps people adhere to a healthy, lower carbohydrate diet,” he said.

“With these drugs, if you’re able to reduce unhealthy carbohydrates [and] increase insulin secretion, the metabolism of carbohydrates improves [while] addressing the eating behavior. It’s like a three-in-one mechanism,” he explained, noting how this can improve the health of other systems in the body.”

Semaglutide is the active ingredient in Ozempic and a type GLP-1 drug.

This class of drugs is widely prescribed for obesity and diabetes management for their ability to regulate blood glucose and aid weight loss. Recent studies have shown other health benefits, such as lowered inflammation.

All of these factors can impact kidney function in people with diabetes, according to Shafipour.

“When blood sugar is chronically elevated — due to a hereditary predisposition, poor eating habits, stress, or sleep and anything that can cause insulin resistance — we start depositing fat in the liver, and everything from head to toe in the body gets sugar-coated, the nerves, eyes, kidney, and stomach,” he said, noting that diabetes can take years to develop.

“That’s why in diabetics, it’s very important to have an eye exam, it’s very important to check their kidney function because everything can get impacted by this higher level of glucose.”

Shafipour explained that with diabetes, kidney filtration, measured by the glomerular filtration rate (GFR), goes down. Then, albumin and protein develop in the urine followed by creatinine in the blood, affecting the body’s metabolization process.

“What we’ve seen with this class of drugs is that kidney function in diabetics stabilizes and it prevents progression,” he said. “And if people start losing weight, their blood pressure goes down and the pressure on the kidney goes down. Then the creatinine starts going down again, improving the GFR.”

Shafipour noted, however, that people with significant kidney disease or very low GFR may not experience improvement from semaglutide-containing drugs.

“I’ve seen prevention of it worsening and improvement in people with [moderate] kidney disease,” he said.

The kidneys contain millions of microscopic filters called nephrons.

In diabetes, elevated blood sugar levels damage nephrons and blood vessels in the kidneys, impairing function and filtration processes.

People with diabetes may also develop high blood pressure, which can lead to kidney damage.

“Hypertension by itself is one of the main causes of kidney disease,” Shafipour said.

“There’s a lot, again a lot, of other things such as inflammation at stake, probably related to high levels of cortisol inflammatory markers. It’s a very complex process,” he noted.

A growing body of evidence shows the potential benefits of Ozempic and similar drugs to treat health conditions beyond obesity and diabetes.

Shafipour said that GLP-1 drugs may soon gain approval for heart disease and chronic kidney disease.

“We already see cardiologists recommending them for people with heart disease, congestive heart failure, etc., because of the positive benefits,” he said.

“There’s a lot of these chronic inflammatory states that cause insulin resistance, fatty liver disease, or metabolic syndrome. We classify all of these into individual conditions and there’s subspecialties for each, but when we really look at the big picture, they’re all related.”

Novo Nordisk recently announced the results of a new trial showing Ozempic delayed the progression of kidney disease-related events in people with diabetes and CKD.

The findings, which have yet to be published, suggest the clinical trial cut the risk of death from kidney and cardiovascular deaths by 24%.

The company ended the FLOW trial a year early due to its demonstrated effectiveness.

The results add to growing evidence suggesting that semaglutide-containing drugs from the GLP-1 class could be used to treat other health conditions aside from obesity and type 2 diabetes.