Jan. 29, 2025 -- The FDA has approved Novo Nordisk's diabetes drug Ozempic to help reduce the risk of worsening kidney disease, kidney failure, and heart-related death in adults with type 2 diabetes and chronic kidney disease (CKD). With this approval, Ozempic becomes the most broadly indicated drug in its class, now covering diabetes control, heart disease risk reduction, and kidney protection.
CKD affects about 37 million adults in the United States and occurs when the kidneys cannot properly filter waste and fluid from the blood. It gets worse over time and can lead to kidney failure, requiring dialysis. Type 2 diabetes is the leading cause, affecting about 40% of patients with diabetes. High blood sugar damages kidney blood vessels, reducing their ability to filter properly and increasing the risk for heart disease, high blood pressure, and other serious complications.
Ozempic – its generic name is semaglutide -- is a type of glucagon-like peptide 1 receptor agonist (GLP-1 RA), a drug that mimics a natural hormone that helps to regulate blood sugar. GLP-1 may protect the kidneys by improving blood flow, reducing inflammation, and preventing damage. Ozempic targets kidney and immune cells, lowering the production of substances that cause damage to these cells. It comes as an injection in a prefilled pen, which patients or caregivers can learn to use with proper training.
The FDA approval was based on a clinical trial involving more than 3,500 adults with type 2 diabetes and CKD across 28 countries. The study compared the effects of a once-weekly 1-milligram Ozempic injection versus a placebo, both given alongside standard treatment, on kidney and heart health. Results showed that Ozempic reduced the risk of worsening kidney disease, kidney failure, or death from heart disease by 24% over three years compared to the placebo. The trial was stopped early after meeting its success criteria sooner than expected.
The most common side effects of Ozempic may include nausea, vomiting, diarrhea, stomach pain, and constipation. It may also cause changes in vision, low blood sugar levels (hypoglycemia), dehydration, and allergic reactions.
Ozempic may also increase the risk for thyroid tumors, according to the drug’s maker. Patients should inform their doctors if they have a family history of thyroid cancer or experience symptoms like lumps in the neck, hoarseness, trouble swallowing, or shortness of breath. They should also discuss any preexisting conditions such as problems with the stomach, pancreas, or eyes. Patients must tell their health care provider if they are pregnant, breastfeeding, or scheduled for surgery and about all the medicines they take.
