✓ FDA APPROVED January 28, 2025
Ozempic (semaglutide) approved to reduce kidney disease progression and cardiovascular death in adults with type 2 diabetes and CKD
First and only GLP-1 RA approved for this indication
On January 28, 2025, the FDA approved Ozempic (semaglutide) to reduce the risk of worsening kidney disease, kidney failure, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease (CKD). This makes semaglutide the most broadly indicated GLP-1 receptor agonist available.
The approval was based on the landmark FLOW trial, which was stopped early because the benefits were so clear.
Why This Matters
Chronic kidney disease affects approximately 37 million adults in the United States. It's a common complication of type 2 diabetes, affecting roughly 40% of people with the condition. When diabetes and CKD combine, patients face significantly elevated risks of:
- Kidney failure requiring dialysis or transplant
- Cardiovascular events (heart attack, stroke)
- Death from cardiovascular causes
Diabetes is the leading cause of CKD and kidney failure in the U.S. With an aging population and increasing diabetes prevalence, the need for effective kidney-protective therapies has never been greater.
The FLOW Trial
FLOW (Effect of Semaglutide Versus Placebo on the Progression of Renal Impairment in Subjects With Type 2 Diabetes and Chronic Kidney Disease) was an international, randomized, double-blind, placebo-controlled trial published in the New England Journal of Medicine in May 2024.
| Participants | 3,533 adults with type 2 diabetes and CKD |
| Sites | 387 sites in 28 countries |
| Treatment | Semaglutide 1.0 mg weekly vs. placebo (added to standard of care) |
| Median follow-up | 3.4 years |
| Trial status | Stopped early for efficacy at interim analysis |
Inclusion Criteria
Patients had type 2 diabetes plus chronic kidney disease, defined as:
- eGFR 50-75 ml/min/1.73m² with urinary albumin-to-creatinine ratio (UACR) >300 and <5000, OR
- eGFR 25-50 ml/min/1.73m² with UACR >100 and <5000
The Independent Data Monitoring Committee recommended stopping FLOW early because semaglutide had already met pre-specified efficacy criteria—meaning the benefits were so clear that it would be unethical to continue denying the placebo group access to treatment.
Primary Results
The primary endpoint was major kidney disease events—a composite of:
- Onset of kidney failure (dialysis, transplant, or eGFR <15)
- ≥50% reduction in eGFR from baseline
- Death from kidney-related or cardiovascular causes
| Outcome | Semaglutide | Placebo | Hazard Ratio |
|---|---|---|---|
| Primary composite | 331 events | 410 events | 0.76 (24% reduction) |
| Kidney-specific events | — | — | 0.79 (21% reduction) |
| Cardiovascular death | — | — | 0.71 (29% reduction) |
The absolute risk reduction at 3 years was 4.9%—meaning for every 20 patients treated with semaglutide, one major kidney or cardiovascular event was prevented.
Secondary Outcomes
Semaglutide met all confirmatory secondary endpoints:
| Outcome | Result | P-value |
|---|---|---|
| eGFR decline (annual slope) | 1.16 ml/min/1.73m² slower decline | <0.001 |
| Major cardiovascular events | 18% reduction (HR 0.82) | 0.029 |
| All-cause death | 20% reduction (HR 0.80) | — |
Safety Profile
Serious adverse events were actually lower in the semaglutide group compared to placebo:
- Semaglutide: 49.6% experienced any serious adverse event
- Placebo: 53.8% experienced any serious adverse event
Common side effects were consistent with other semaglutide trials—primarily gastrointestinal symptoms like nausea, vomiting, and diarrhea.
The "Four Pillars" of CKD Treatment
This approval adds GLP-1 agonists to what Dr. Tuttle calls the "four pillars" of care for people with CKD and type 2 diabetes:
- SGLT2 inhibitors (e.g., empagliflozin, dapagliflozin)
- GLP-1 receptor agonists (now including semaglutide for CKD)
- Mineralocorticoid receptor antagonists (e.g., finerenone)
- RAAS inhibitors (ACE inhibitors, ARBs)
"This is a big step to now approve it just in the context of diabetes and CKD alone, which could open the door for a lot of patients that need this," noted Matthew Sparks, MD, of Duke University. Many insurers had previously balked at covering semaglutide for patients without obesity—this new indication may expand access.
Ozempic's Expanding Indications
With this approval, semaglutide (Ozempic) is now FDA-approved for:
| Year | Indication |
|---|---|
| 2017 | Improve glycemic control in type 2 diabetes |
| 2020 | Reduce major cardiovascular events in T2D with heart disease |
| 2025 | Reduce worsening kidney disease and CV death in T2D with CKD |
This makes Ozempic the only GLP-1 receptor agonist with all three indications—the most broadly indicated in its class.
What We Don't Know
While FLOW was a major success, questions remain:
- CKD without diabetes? The trial only included patients with type 2 diabetes. Whether semaglutide protects kidneys in people with CKD from other causes is unknown.
- Optimal timing? Would earlier treatment (before significant CKD develops) provide even greater benefit?
- Combination with SGLT2 inhibitors? Many patients were already on SGLT2 inhibitors—the additive benefit of GLP-1 agonists needs more study.
- Long-term outcomes beyond 3.4 years? Sustained benefits will need continued follow-up.
The FLOW trial demonstrated that semaglutide significantly reduces the risk of kidney failure, cardiovascular death, and major cardiovascular events in patients with type 2 diabetes and chronic kidney disease. The 24% reduction in the primary composite endpoint—and the trial being stopped early for clear efficacy—represent a major advance for the 37 million Americans with CKD. For patients with both type 2 diabetes and CKD, this approval adds a powerful tool to the arsenal of kidney-protective therapies. As Dr. Tuttle summarized: "This is part of the revolution in CKD therapies."
Sources
- Novo Nordisk. "FDA approves Ozempic (semaglutide) as the only GLP-1 RA to reduce the risk of worsening kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease." Press release. January 28, 2025.
- Perkovic V, Tuttle KR, Rossing P, et al. "Effects of semaglutide on chronic kidney disease in patients with type 2 diabetes." New England Journal of Medicine. 2024. doi:10.1056/NEJMoa2403347
- International Society of Nephrology. "The FLOW study: Effects of Semaglutide on chronic kidney disease in patients with type 2 diabetes." November 2024.
- Kidney News. "FDA, EU Regulators Expand Indications for Semaglutide to Include Kidney Benefits." March 2025.
- AJMC. "FDA Expands Semaglutide Use for CV, Kidney Risks in T2D, CKD." December 2025.
- ClinicalTrials.gov. FLOW trial (NCT03819153).
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