FLOW is a kidney trial. It belongs on a GLP-1 site because it is one of the few incretin trials with a hard organ endpoint, and because it was stopped early for benefit.
What the trial asked
Whether semaglutide 1.0 mg reduces major kidney disease events, cardiovascular events and death in people with type 2 diabetes and chronic kidney disease.
Design
Randomised, placebo-controlled. Subcutaneous semaglutide 1.0 mg weekly versus placebo. The primary outcome was a composite of major kidney disease events: onset of kidney failure (dialysis, transplantation or eGFR under 15), at least a 50 percent fall in eGFR from baseline, or death from kidney-related or cardiovascular causes. Confirmatory secondary outcomes were tested in a prespecified hierarchy. Early trial cessation was recommended at a prespecified interim analysis; median follow-up was 3.4 years.
Who was enrolled
3533 patients with type 2 diabetes and chronic kidney disease, defined as eGFR 50 to 75 with a urinary albumin-to-creatinine ratio above 300 and below 5000, or eGFR 25 to under 50 with a ratio above 100 and below 5000. 1767 were randomised to semaglutide and 1766 to placebo.
Primary endpoint and result
Primary-outcome events: 331 on semaglutide versus 410 on placebo. Hazard ratio 0.76 (95% CI 0.66 to 0.88; P=0.0003), a 24 percent lower risk.
Key secondary results
All confirmatory secondary outcomes favoured semaglutide:
| Outcome | Result |
|---|---|
| Kidney-specific components of the primary outcome | HR 0.79 (95% CI 0.66 to 0.94) |
| Death from cardiovascular causes | HR 0.71 (95% CI 0.56 to 0.89) |
| Annual eGFR slope | Less steep by 1.16 mL/min/1.73 m2 per year (P less than 0.001) |
| Major cardiovascular events | HR 0.82 (95% CI 0.68 to 0.98; P=0.029), 18 percent lower |
| Death from any cause | HR 0.80 (95% CI 0.67 to 0.95; P=0.01), 20 percent lower |
Adverse events and discontinuation
Serious adverse events were reported in a lower percentage on semaglutide than placebo: 49.6 versus 53.8 percent. The abstract does not give discontinuation rates or itemise gastrointestinal events.
Funding and registration
Novo Nordisk. ClinicalTrials.gov NCT03819153.
What this trial does not show
- It is a 1.0 mg trial in people with diabetes and kidney disease. It is not evidence about 2.4 mg, about people without diabetes, or about kidneys in people with normal function.
- Early stopping for benefit tends, on average, to overestimate effect sizes. The confidence interval is the honest range.
- Weight change is not in the abstract and was not the point.
- The absolute event counts (331 versus 410 over a median 3.4 years in about 1767 per arm) are the numbers to keep; the 24 percent is relative.
Where the numbers come from
PubMed abstract of the primary paper (PubMed 38785209), fetched 4 September 2026. For the cardiovascular trial in obesity without diabetes, see SELECT.
Sources (2)
Show the referencesHide
- Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes (FLOW). N Engl J Med 2024;391(2):109-121. PubMed 38785209 Accessed September 4, 2026.
- ClinicalTrials.gov NCT03819153 Accessed September 4, 2026.
Canonical URL: https://formblendsresearch.com/trials/flow. Written by the FormBlends editorial team. This page is educational and is not medical advice; see the medical disclaimer.