Impact of Oral Semaglutide on Kidney Outcomes in People With Type 2 Diabetes: Results From the SOUL Randomized Trial
Primary result · Five-point kidney composite (≥50% eGFR decrease, persistent eGFR <15 mL/min/1.73 m², chronic kidney replacement therapy initiation, or kidney or CV death)Result — go to the resultHazard ratio 0.91 95% CI 0.80–1.05Authors' conclusion
In people with T2D and ASCVD and/or CKD but with overall mostly preserved eGFR, orally administered semaglutide, compared with placebo, did not significantly reduce adverse kidney outcomes but did slow the decline in eGFR.
Study context
- Population
- People with T2D and atherosclerotic CVD (atherosclerotic cardiovascular disease (ASCVD)) and/or chronic kidney disease (CKD); mean eGFR 73.8 mL/min/1.73 m²
- Participants
- 9,650 people
- Comparison
- Oral semaglutide vs placebo
Methodological detailsdouble-blind, prespecified kidney outcomes, prespecified subgroups
- Double-blind
- Prespecified kidney outcomes
- Prespecified subgroups
Primary result
As reported in the abstract
Five-point kidney composite:
- ≥50% eGFR decrease
- Persistent eGFR <15 mL/min/1.73 m²
- Chronic kidney replacement therapy initiation
- Kidney or cardiovascular (CV) death
Hazard ratio
0.91
95% CI 0.80–1.05
P = 0.19
Events by treatment group
Oral semaglutidevs Placebo
HR 0.91 (95% CI 0.80–1.05); P = 0.19
Further findings
| Outcome | Oral semaglutide | Placebo | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Four-point kidney composite (excluding CV death) | 2.3% | 2.7% | 0.86 (0.66–1.10) | P = 0.22 | |
| 0.512Hazard ratio (log scale) |
Mean, mL/min/1.73 m²
| Outcome | Oral semaglutide | Placebo | Estimated treatment difference (95% CI) | P value | |
|---|---|---|---|---|---|
| Mean annual eGFR declineLess decline with oral semaglutide | −1.67 | −2.06 | 0.40 (0.27–0.53) | P < 0.0001 | |
| −0.500.51Difference (linear scale) |
Subgroups, incl. eGFR <60 mL/min/1.73 m² at baseline
- Effects similar across most subgroups, including eGFR <60 mL/min/1.73 m²
Safety
- Serious adverse events occurred at similar rates in both groups
Original publication
Impact of Oral Semaglutide on Kidney Outcomes in People With Type 2 Diabetes: Results From the SOUL Randomized Trial. Diabetes Care. Published 4 December 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →