The FLOW trial semaglutide results answer one narrow, important question. Among adults who already had type 2 diabetes and chronic kidney disease, serious kidney or cardiovascular outcomes occurred in 18.7% of people assigned semaglutide and 23.2% assigned placebo. That works out to a 24% lower risk over time. It does not mean semaglutide repaired damaged kidneys, and it does not describe everyone with kidney disease.
What question did FLOW ask?
FLOW was built to find out whether branded semaglutide could delay major kidney problems in people with both type 2 diabetes and chronic kidney disease. It was randomized, meaning treatment was assigned by chance; double-blind, meaning neither participants nor study staff knew the assignment; and placebo-controlled, meaning one group received an inactive comparison injection.
The published FLOW paper and trial registry, NCT03819153, show that 1,767 people received semaglutide and 1,766 received placebo on top of their usual care. Median follow-up was 3.4 years. The trial stopped early for efficacy, meaning a planned interim check found that its preset evidence threshold had been met.
Who was enrolled, and who was not?
The 3,533 randomized participants were adults with type 2 diabetes and chronic kidney disease. Their average age was 66.6, about 3 in 10 were women, and their average eGFR was 47. eGFR is a blood-test estimate of how quickly the kidneys filter.
Entry also required elevated urine albumin, a protein that leaks into urine when kidney filters are damaged. The exact kidney-function and albumin ranges are documented in the FLOW design paper. People already receiving recent dialysis, people with type 1 diabetes, and pregnant or breastfeeding people were among those excluded. That matters: FLOW cannot answer the same question for those groups.
What did the trial measure?
The primary endpoint was a composite endpoint, one score made from several serious events. It counted the first occurrence of kidney failure requiring long-term dialysis or transplant, an eGFR below 15, a lasting drop of at least 50% from the starting eGFR, or death from kidney or cardiovascular causes.
Combining events can give a trial enough information sooner, but it also means the 24% headline cannot be read as a 24% reduction in dialysis alone. Cardiovascular deaths were part of the count.
FLOW trial semaglutide results: the main numbers
The primary outcome occurred in 331 of 1,767 semaglutide participants, or 18.7%, and 410 of 1,766 placebo participants, or 23.2%. The hazard ratio was 0.76. A hazard ratio compares how quickly events happen over time; 0.76 means the event rate was 24% lower in the semaglutide group during the trial.
Kidney function also declined more slowly. The average annual eGFR slope differed by 1.16 mL/min/1.73 m² in favor of semaglutide. Major cardiovascular events had a hazard ratio of 0.82, and death from any cause had a hazard ratio of 0.80. These are group averages from FLOW, not forecasts for one person.
What the FLOW side-effect table shows
An adverse event is a medical problem recorded during a study, whether or not the treatment caused it. FLOW collected serious events and selected predefined events rather than every everyday symptom, so this is not a nausea-rate table.
| Safety result in FLOW | Semaglutide | Placebo |
|---|---|---|
| Serious adverse event | 49.6% | 53.8% |
| Adverse event leading to permanent treatment stop | 13.2% | 11.9% |
| Gastrointestinal disorder leading to permanent stop | 4.5% | 1.1% |
The balance is easy to miss: serious events were recorded less often with semaglutide overall, while permanent stopping because of side effects was slightly more common, driven mainly by stomach and intestinal problems.
What critics and later research add
A published New England Journal of Medicine exchange raised a practical limitation: only 16% of FLOW participants were taking an SGLT2 inhibitor at the start, and use of some other newer kidney medicines was limited. A later prespecified analysis found no clear evidence that semaglutide's effect differed by baseline SGLT2 use, but only 550 participants were in that subgroup, leaving wide uncertainty (Mann et al., Nature Medicine, 2024).
As of September 18, 2026, the day this article was written, the newest relevant publication is an August 7 pooled analysis of FLOW, SELECT, and SOUL. Across 30,787 participants, the same broad kidney composite occurred 973 times with semaglutide and 1,134 times with placebo, a hazard ratio of 0.84. That broader analysis supports the direction of FLOW, but it mixed three populations, doses, and oral and injected products. The semaglutide and kidney disease overview puts those wider findings in context.
How FLOW changed the label
On January 28, 2025, the FDA added a kidney indication to Ozempic for adults with type 2 diabetes and chronic kidney disease. The current prescribing information says "Revised: 5/2026" and still lists reducing the risk of sustained eGFR decline, end-stage kidney disease, and cardiovascular death in that population.
Through Promise, semaglutide is dispensed as a compounded medication, which is different from an FDA-approved product: the formulation offered here is not FDA-approved. FLOW did not test that compounded preparation. A licensed provider may still prescribe a compounded formulation; that decision is between the patient and the doctor.
What FLOW means for a prescription decision
FLOW is strong evidence for the branded product, dose, and population it studied. It cannot decide whether semaglutide fits a person with a different cause of kidney disease, predict an individual result, or substitute for recent kidney tests and a full medication review. The tirzepatide kidney evidence is a separate record and should not be treated as interchangeable.
At Promise, a licensed provider reviews every request, and not everyone qualifies. Kidney history, current eGFR, urine protein, diabetes medicines, and past trouble with dehydration all belong in that review.
