Ozempic is the only GLP-1 drug whose US label carries a kidney indication. It comes from one trial, FLOW, in which 3,533 adults with type 2 diabetes and chronic kidney disease took semaglutide 1.0 mg weekly or placebo. Major kidney disease events occurred in 18.7% on semaglutide and 23.2% on placebo — a 24% lower risk — and the trial was stopped early because the difference was clear. At the same time, every GLP-1 label carries a warning about acute kidney injury, almost always after dehydration from stomach side effects. The two facts answer different questions, and this page keeps them apart.
The labels were read on 17 October 2026 from DailyMed, the FLOW record from ClinicalTrials.gov and its publication in the New England Journal of Medicine. It reports what the documents say; it does not advise on treatment.
What FLOW tested
FLOW (NCT03819153) was a randomised, double-blind, placebo-controlled trial sponsored by Novo Nordisk. It enrolled adults with type 2 diabetes and chronic kidney disease defined by two measures: eGFR between 25 and 75 mL/min/1.73 m² and protein (albumin) leaking into the urine, at an albumin-to-creatinine ratio above 100 and below 5,000 mg/g. The label states that participants received standard background care, including the maximum tolerated dose of a renin-angiotensin system blocker, the blood-pressure drug class used to protect the kidneys. The primary outcome was a composite of kidney failure, a sustained 50% fall in eGFR, or death from kidney or cardiovascular causes.
The trial was event-driven and planned to run for up to five years. It completed in January 2024, after its independent committee recommended stopping at a prespecified interim analysis; median follow-up was 3.4 years.
The results, component by component
| Outcome | Placebo (n=1,766) | Semaglutide 1.0 mg (n=1,767) | Hazard ratio (95% CI) |
|---|---|---|---|
| Major kidney disease events (primary) | 410 (23.2%) | 331 (18.7%) | 0.76 (0.66 to 0.88) |
| ≥50% sustained fall in eGFR | 213 (12.1%) | 165 (9.3%) | 0.73 (0.59 to 0.89) |
| Sustained eGFR below 15 | 110 (6.2%) | 92 (5.2%) | 0.80 (0.61 to 1.06) |
| Starting chronic dialysis or transplant | 100 (5.7%) | 87 (4.9%) | 0.84 (0.63 to 1.12) |
| Kidney death | 5 (0.3%) | 5 (0.3%) | 0.97 (0.27 to 3.49) |
| Cardiovascular death | 169 (9.6%) | 123 (7.0%) | 0.71 (0.56 to 0.89) |
| Heart attack, stroke or cardiovascular death | 254 (14.4%) | 212 (12.0%) | 0.82 (0.68 to 0.98) |
| Death from any cause | 279 (15.8%) | 227 (12.8%) | 0.80 (0.67 to 0.95) |
| Annual change in eGFR | -3.36 | -2.19 | difference 1.16 a year |
Sources: Ozempic label (Novo Nordisk, effective 2026-06-01), section 14, Table 10; ClinicalTrials.gov NCT03819153 posted results (eGFR slope); Perkovic et al., NEJM 2024 (slope difference). eGFR in mL/min/1.73 m².
How to read it.
- The absolute difference in the primary outcome is 4.5 percentage points: roughly one major kidney event avoided for every 22 people treated over about three and a half years. That is our arithmetic from the label's counts, not a figure the label or paper states.
- The result leans on two components. The 50% eGFR fall and cardiovascular death each separated clearly. Kidney failure, dialysis and kidney death, taken individually, had confidence intervals that crossed 1 — fewer events on semaglutide, but too few to show a difference on their own. The kidney-only composite in the paper was 0.79 (0.66 to 0.94).
- Who it applies to. Everyone in FLOW had type 2 diabetes, protein in the urine and a reduced eGFR. The result says nothing direct about people with kidney disease but no diabetes, or about kidney health in people taking GLP-1 drugs for weight loss.
The label also notes that FLOW collected safety data only for serious adverse events and selected categories. Serious adverse events were reported in 877 of 1,767 people on semaglutide and 950 of 1,766 on placebo in the registry results (49.6% against 53.8%, our arithmetic).
The other labels: no kidney trial on any of them
| Label | Kidney indication | Dosing in kidney impairment |
|---|---|---|
| Ozempic (semaglutide) | Yes, from FLOW | No adjustment recommended |
| Wegovy (semaglutide) | No | — |
| Mounjaro (tirzepatide) | No | No adjustment recommended, including end-stage renal disease |
| Zepbound (tirzepatide) | No | No adjustment recommended, including end-stage renal disease |
| Foundayo, Saxenda, Victoza, Trulicity | No | — |
Sources: each manufacturer's label on DailyMed, sections 1 and 8.6, read 2026-10-17. A dash means the dosing statement was not extracted for this page, not that the label is silent.
Wegovy uses the same molecule as Ozempic, but FLOW tested the 1.0 mg diabetes dose in people with diabetes, and the indication sits on Ozempic's label only. For tirzepatide, the one registered kidney trial found on ClinicalTrials.gov, TREASURE-CKD (NCT05536804), is a 134-person phase 2 study in people with obesity and chronic kidney disease, with or without diabetes. Its primary outcome is the change in fat around the kidney on MRI at 52 weeks, not kidney failure. It completed in July 2026 and had no results posted when its record was read on 17 October 2026.
The acute kidney injury warning
All eight labels warn about acute kidney injury. Ozempic's wording describes postmarketing reports, "in some cases requiring hemodialysis", most of which "occurred in patients who experienced gastrointestinal reactions leading to dehydration such as nausea, vomiting, or diarrhea". The labels ask prescribers to monitor kidney function in people reporting reactions that could cause fluid loss. Mounjaro's adds monitoring when starting or increasing the dose in people with kidney impairment.
This is a separate mechanism from the one FLOW studied. It is a short-term injury from fluid loss, linked to the drugs' commonest side effects, and it is why the stomach side effects matter beyond comfort. Those rates, drug by drug, are on GLP-1 nausea and GLP-1 diarrhoea.
What is not established
- Kidney outcomes without diabetes. No completed outcome trial of a GLP-1 drug in people with chronic kidney disease but no diabetes was found.
- Tirzepatide's effect on kidney disease progression. No outcome trial; TREASURE-CKD measures an imaging marker and has no posted results.
- Kidney outcomes at weight-loss doses. FLOW used 1.0 mg; Wegovy's 2.4 mg and 7.2 mg doses and Zepbound have no kidney-outcome trial on their labels.
- How it combines with other kidney medicines. FLOW required a renin-angiotensin system blocker as background treatment; it was not designed to test semaglutide against or alongside other kidney-protecting drugs.
Whether a GLP-1 drug suits a person with kidney disease, and how their kidney function is monitored on it, is for their nephrologist or prescriber. Related pages: what Ozempic is, Ozempic for type 2 diabetes, Victoza vs Ozempic and the GLP-1 side effects hub.
Sources
- OZEMPIC (semaglutide) injection, Novo Nordisk, label effective 2026-06-01 (set ID adec4fd2-6858-4c99-91d4-531f5f2a2d79), sections 1, 5.6, 6.1, 8.6 and 14.3 (Table 10), dailymed.nlm.nih.gov, read 2026-10-17. Also read the same day: WEGOVY, MOUNJARO (effective 2026-08-27), ZEPBOUND (2026-08-28), FOUNDAYO, SAXENDA, VICTOZA, TRULICITY.
- ClinicalTrials.gov NCT03819153 (FLOW), posted results, read 2026-10-17.
- Perkovic V et al. "Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes." N Engl J Med 2024, PubMed 38785209.
- ClinicalTrials.gov NCT05536804 (TREASURE-CKD), record read 2026-10-17; search "tirzepatide chronic kidney disease", 11 records, the same day.