Trial results for semaglutide in people with Type 2 diabetes and chronic kidney disease were posted on ClinicalTrials.gov on 2025-03-20. The study demonstrated that semaglutide significantly reduced the risk of a composite renal event by 24% compared to placebo, with a Hazard Ratio (HR) of 0.76 (95% CI: 0.66 to 0.88).
Background
Semaglutide is a medication prescribed in some countries for the treatment of Type 2 diabetes. This study investigated its potential to slow the progression of chronic kidney disease in individuals also living with Type 2 diabetes.
Trial design
The study (NCT03819153) was a Phase 3, randomized, placebo-controlled trial that enrolled 3533 participants. The trial investigated semaglutide compared to placebo in people with Type 2 diabetes and chronic kidney disease. Participants received either semaglutide or a placebo once a week via subcutaneous injection. The study aimed to evaluate if semaglutide could slow the worsening of chronic kidney disease in this population.
Key results
The key analysis for the composite renal outcome showed a significant benefit for semaglutide. This composite outcome included the first occurrence of persistent ≥50% reduction in eGFR, persistent eGFR <15mL/Min/1.73m^2, initiation of chronic renal replacement therapy, renal death, or cardiovascular death.
- In the semaglutide group, 331 participants experienced this composite event.
- In the placebo group, 410 participants experienced this composite event.
A Cox proportional hazards model analysis for this composite outcome yielded a Hazard Ratio (HR) of 0.76 (95.0% CI: 0.66 to 0.88) with a p-value of 0.0001, indicating a statistically significant reduction in risk with semaglutide.
Regarding the annual rate of change in eGFR (CKD-EPI), the results were:
- Semaglutide group: mean change of -2.19 (mL/min/1.73 m^2)/year (Standard Error: 0.1).
- Placebo group: mean change of -3.36 (mL/min/1.73 m^2)/year (Standard Error: 0.1).
Further specific components of renal events were also reported:
- Persistent ≥50% reduction in eGFR: 165 participants in the semaglutide group vs 213 in the placebo group.
- Persistent eGFR <15mL/Min/1.73m^2: 92 participants in the semaglutide group vs 110 in the placebo group.
- Initiation of chronic renal replacement therapy: 87 participants in the semaglutide group vs 100 in the placebo group.
- Renal death: 5 participants in the semaglutide group vs 5 in the placebo group.
What this means
The trial results suggest that semaglutide offers a significant benefit in slowing the progression of kidney disease in patients with Type 2 diabetes and chronic kidney disease. The observed reduction in the composite renal event and the slower decline in eGFR compared to placebo indicate a potential to preserve kidney function and reduce the need for renal replacement therapies. These findings are important for guiding treatment decisions for this vulnerable patient population.
Source
The information for these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03819153, titled "A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease," were posted on 2025-03-20 on clinicaltrials.gov.