FDA approves Ozempic for those with chronic kidney disease & type 2 diabetes

Since Ozempic® was first approved by the Food and Drug Administration in 2017 as a treatment for type 2 diabetes, it has been hailed as a miracle drug. Its active ingredient, semaglutide, has been shown to help regulate blood sugar, support weight loss, and improve cardiovascular health. (In fact, in 2020, Ozempic was also approved as a treatment to reduce the risks of life-threatening cardiovascular events like stroke and heart attack in those with type 2 diabetes and a history of heart disease.)

More recently, in January 2025, the FDA added another indication to the list when it approved Ozempic as a treatment to reduce the risk of major kidney events and worsening kidney disease in those with type 2 diabetes and chronic kidney disease. 

What study led to this FDA approval?  

The FDA’s latest approval is based on results from the FLOW trial. This clinical trial, funded by Novo Nordisk and involving more than 3,500 participants, looked at people who already had both type 2 diabetes and chronic kidney disease. 

Participants were given either a weekly dose of 1.0 mg semaglutide or a placebo. After 3.4 years, those who took semaglutide were 24% less likely to have a major kidney disease event (such as kidney failure) than those in the placebo group. In addition, people who took semaglutide had a slower progression of chronic kidney disease (CKD). The effect on kidney outcomes was so significant that the trial ended early because evidence showed that semaglutide slowed the progression of kidney disease.

What is kidney disease? 

Kidney health is measured using several lab results. Among the most important ones are a blood test—the estimated glomerular filtration rate (eGFR)—and tests that measure the creatinine and albuminuria levels.

An eGFR indicates how quickly the kidneys filter the blood. It estimates how much blood passes through the glomeruli (the part of the kidneys that filters blood) each minute. According to the National Kidney Foundation, normal eGFR is 90 to 120. While it is normal to see a decrease in eGFR as one ages, or a temporary decrease while acutely ill, a sustained eGFR lower than 60 indicates kidney disease. A GFR lower than 15 indicates kidney failure, and usually requires dialysis or a kidney transplant. 

Creatinine is another lab test that can help measure the health of the kidneys. When the body breaks down muscle or digests protein, it produces creatinine as a waste product. Normally, the kidneys filter creatinine out of the blood and remove it from the body in the urine. A creatinine test can measure the amount of creatinine in the blood (a creatinine blood test), the amount in the urine (a creatinine urine test), or the ratio of creatinine in blood and urine (a creatinine clearance calculation). If the kidneys are healthy, most of the creatinine will be filtered out of the blood and evacuated from the body in the urine. Unhealthy kidneys will leave more creatinine in the blood. 

Microalbuminuria is another test that can indicate potential kidney disease. This test measures the amount of albumin in the urine. Albumin is a protein in blood that helps keep fluid within the blood vessels. Healthy kidneys prevent albumin from entering the urine, but if the kidneys are damaged, albumin can leak into the urine. 

Another indicator of kidney health drawn from a lab test is the microalbumin creatinine ratio. Healthy kidneys will filter most creatinine out of the blood into the urine and  keep albumin in the blood, preventing it from getting in the urine. The ratio of albumin to creatinine in the urine helps doctors measure how well the kidneys function. 

How does Ozempic help kidney disease? 

Although studies indicate that taking Ozempic reduces the risk of worsening kidney disease, researchers don’t yet know why it works. 

The association between kidney disease and obesity, diabetes, and cardiovascular disease is well-established, so it’s likely that some of the protective effects of Ozempic stem from its ability to help with weight loss, lowering blood pressure, and controlling blood glucose. 

However, the FLOW study concluded that Ozempic’s ability to prevent worsening kidney problems is more significant than what would be expected if weight loss alone caused the positive impact on kidney health. More studies are needed to understand other Ozempic mechanisms that promote kidney protection. 

Does Ozempic cause side effects? 

The most common side effects of Ozempic (semaglutide) are gastrointestinal issues, including nausea, vomiting, diarrhea, and stomach pain. Stomach paralysis (gastroparesis) and other serious side effects have occurred. 

Although rare, in animal studies, semaglutide caused thyroid C-cell tumors. Ozempic’s “black box” warns of the risk of these tumors. If you have trouble swallowing, develop hoarseness, or feel swelling or a lump in your neck, contact your health care provider immediately. The FDA also warns not to take Ozempic if you have or have a family history of multiple endocrine neoplasia syndrome type 2 or medullary thyroid cancer. Ozempic is not appropriate for treating insulin-dependent diabetes, and may increase the risk of diabetic ketoacidosis. So, if that’s you, Ozempic isn’t the right fit. Find more details about side effects and risks on our dedicated Ozempic page. 

The FDA’s latest approval of Ozempic as a treatment to slow the progression of kidney disease is a major milestone for this important medication. While its benefits for weight loss, diabetes management, and cardiovascular outcomes are already well known, Ozempic’s new indication highlights its potential to protect kidney health and improve long-term health outcomes. 

As researchers continue to explore exactly how Ozempic benefits the kidneys beyond its effects on blood sugar and weight, this approval reinforces semaglutide’s reputation as a game-changing medication. If you’re on Ozempic or considering taking it, especially if you have been diagnosed with chronic kidney disease, this new approval adds another reason to talk to your doctor about whether it’s the right choice for you. 

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Found is not affiliated with or endorsed by Novo Nordisk A/S, the owner of the registered trademarks Wegovy® and Ozempic®. The content provided is for informational purposes only and should not be used as a basis for diagnosing or treating any health condition, or for determining actual costs incurred. Always follow your health care provider’s instructions to ensure safe and effective management of your health conditions. Certain medications are only FDA approved to treat conditions other than weight but may be prescribed to help aid in weight loss. Prescriptions are up to a medical provider’s discretion. For key risk information by drug, visit the Found medication page.