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Randomized controlled trial

FLOW: semaglutide (Ozempic) and kidney disease in type 2 diabetes

Over a median follow-up of 3.4 years, the primary outcome occurred in 331 patients on semaglutide and 410 on placebo, a 24% lower risk (hazard ratio 0.76; 95% CI, 0.66 to 0.88).

Perkovic V 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

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Key facts

Drug
semaglutide
Design
Randomized controlled trial
Participants
3,533
Duration
Event-driven (follow-up is given in the results)
Funding
Novo Nordisk
Registry
NCT03819153
Population
3,533 patients with type 2 diabetes and chronic kidney disease (estimated glomerular filtration rate of 50 to 75 mL/min/1.73 m² with a urine albumin-to-creatinine ratio above 300 and below 5,000 mg/g, or a filtration rate of 25 to below 50 with a ratio above 100 and below 5,000), randomized to semaglutide 1.0 mg once weekly (1,767) or placebo (1,766).
Primary outcome
Major kidney disease events: a composite of the onset of kidney failure (dialysis, transplantation or an estimated glomerular filtration rate below 15 mL/min/1.73 m²), a reduction of at least 50% in filtration rate from baseline, or death from kidney-related or cardiovascular causes, with semaglutide 1.0 mg once weekly versus placebo.

What it found

Over a median follow-up of 3.4 years, the primary outcome occurred in 331 patients on semaglutide and 410 on placebo, a 24% lower risk (hazard ratio 0.76; 95% CI, 0.66 to 0.88). The trial ended earlier than planned, after stopping was recommended at a prespecified interim analysis. Results were similar for the composite of the kidney-specific components (hazard ratio 0.79; 95% CI, 0.66 to 0.94) and for cardiovascular death (hazard ratio 0.71; 95% CI, 0.56 to 0.89). Glomerular filtration rate fell by 1.16 mL/min/1.73 m² less per year with semaglutide, the risk of major cardiovascular events was 18% lower (hazard ratio 0.82; 95% CI, 0.68 to 0.98) and the risk of death from any cause 20% lower (hazard ratio 0.80; 95% CI, 0.67 to 0.95). Serious adverse events occurred in 49.6% on semaglutide and 53.8% on placebo.

Limitations

Funded by Novo Nordisk. It ended earlier than planned after an interim analysis, and trials that stop early can overestimate the size of the effect. It used semaglutide 1.0 mg, a diabetes dose, not the 2.4 mg dose used for obesity. It only included people with type 2 diabetes and chronic kidney disease with albumin in the urine, so it cannot simply be applied to kidney disease without diabetes.

What it means for you

In people with type 2 diabetes and chronic kidney disease, weekly semaglutide 1.0 mg (an Ozempic dose) reduced the risk of major kidney events, such as needing dialysis or losing half of kidney function, by 24%, and also the risk of cardiovascular death, compared with placebo. It was not studied in kidney disease without diabetes. If you have diabetes and kidney problems, it is a useful finding to discuss with your doctor or nephrologist.

Further reading

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Sources

The original paper and the records consulted for this summary, with the date they were accessed.

  1. New England Journal of Medicine.Perkovic V, et al. Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes. N Engl J Med. 2024;391(2):109-121.accessed .
  2. National Library of Medicine (PubMed).PubMed record PMID 38785209 (abstract).accessed .
  3. ClinicalTrials.gov (National Library of Medicine).ClinicalTrials.gov record NCT03819153 (registration and primary outcome).accessed .