- The FDA approved Ozempic to help treat complications associated with chronic kidney disease (CKD).
- Results from the Novo Nordisk-funded FLOW trial have shown that Ozempic lowered the risk of kidney disease-related events in people with CKD and type 2 diabetes.
- Semaglutide had a 24% risk reduction in kidney- and cardiovascular-related mortality, an 18% reduced risk of major cardiovascular events, and a 20% reduced risk of all-cause 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.
The Food and Drug Administration (FDA) approved Ozempic to help lower risks associated with chronic kidney disease, the drug’s manufacturer Novo Nordisk said on January 28.
The blockbuster GLP-1 drug, commonly prescribed off-label for weight loss, was originally approved to treat type 2 diabetes. The new indication for Ozempic adds to a growing number of chronic conditions that can be treated by GLP-1 drugs, in addition to diabetes and obesity.
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Semaglutide, the active ingredient in Ozempic, can help reduce the risk of kidney disease-related events in people with type 2 diabetes (T2D) and CKD, which could prove invaluable for people living with or at risk for cardiovascular-kidney-metabolic (CKM) syndrome, a disorder linking kidney and metabolic issues to heart disease.
In May 2024, Novo Nordisk released the full results from its clinical trial, which showed a 24% risk reduction in kidney- and cardiovascular-related mortality from the once-weekly semaglutide 1.0 milligram injection, and an 18% reduced risk of major cardiovascular events. Further, semaglutide reduced the risk of all-cause mortality in trial participants by 20%.
“Chronic kidney disease is very serious and common in patients living with type 2 diabetes and represents a critical need for adults living with these comorbidities,” Anna Windle, PhD, senior vice president of clinical development, medical and regulatory affairs at Novo Nordisk, said in a statement.
“This approval for Ozempic allows us to more broadly address conditions within cardiovascular-kidney-metabolic syndrome, which affects millions of adults and could have serious consequences if left untreated.”
The results of the FLOW (Evaluate Renal Function with Semaglutide Once Weekly) trial were presented at the 61st European Renal Association Congress in Stockholm last year.
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.
“The use of semaglutide in people with type 2 diabetes and chronic kidney disease can lower the risk of major kidney outcomes and reduce the risk of cardiovascular events, cardiovascular death and all-cause death,” lead study investigator Prof. Vlado Perkovic, provost at Sydney’s University of New South Wales, who presented the study findings, said in a news release.
“These benefits signify a profound clinical impact saving kidneys, hearts and lives, for patients with type 2 diabetes and chronic kidney disease. Additionally, the reassuring safety findings further support the strong potential value of semaglutide in this population,” Perkovic added.
Dr. Pouya Shafipour, board certified family and obesity medicine physician at Providence Saint John’s Health Center in Santa Monica, CA, told Healthline in an earlier interview he was not surprised by the initial results of the trial, which were shared in March 2024.
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
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.
In March 2024, Wegovy, Novo Nordisk’s other semaglutide drug, gained FDA approval to help prevent heart disease-related risks like heart attack in people with overweight or obesity. The company is also working to broaden insurance coverage for Wegovy to meet growing demand for the medication.
“We already see cardiologists recommending them for people with heart disease, congestive heart failure, etc., because of the positive benefits,” Shafipour 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.”
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The FDA has approved Ozempic to help lower chronic kidney disease-related risks in people with type 2 diabetes.
The Novo Nordisk-funded FLOW clinical trial showed that semaglutide delayed the progression of kidney disease-related events in people with diabetes and CKD.
The findings of the trial, which ended a year early due to its demonstrated effectiveness, indicate that Ozempic cut the risk of death from kidney and cardiovascular deaths by 24%.
The FDA approval of Ozempic to treat chronic kidney disease highlights a growing body of evidence showing that GLP-1 drugs could help treat other health conditions aside from obesity and type 2 diabetes.
