The FLOW Trial: Semaglutide's Kidney Disease Evidence
TRIAL-000007
Part of the DietApp.com GLP-1 Trial Database, a comprehensive, regularly reviewed resource.
What It Is
FLOW, Effect of Semaglutide vs. Placebo on Kidney Outcomes in People with Type 2 Diabetes and Chronic Kidney Disease, is a Phase 3 trial specifically designed to test kidney outcomes, unlike earlier trials like LEADER and SUSTAIN-6, which found kidney signals as a secondary finding. It randomized 3,533 adults with type 2 diabetes and established chronic kidney disease to weekly semaglutide 1.0 mg or placebo, with a median follow-up of 3.4 years.
Key Results
FLOW was stopped early at a prespecified interim analysis because the efficacy was already clear. Semaglutide reduced major kidney disease events, a composite of kidney failure, a significant sustained reduction in kidney function, kidney-related death, or cardiovascular death, by 24% compared to placebo. This forms part of the evidence behind Ozempic's kidney disease risk reduction approval.
Why This Trial Was Different
Earlier cardiovascular outcome trials like LEADER and SUSTAIN-6 found kidney benefits as a secondary observation, since they weren't designed primarily to test kidney endpoints. FLOW was purpose-built to answer the kidney question directly, in a population specifically selected for existing chronic kidney disease, giving more definitive evidence than the earlier trials could provide on their own.
References
- Irvine Health: Semaglutide and Kidney Disease, The FLOW Trial
- Circulation: Effect of Semaglutide and Liraglutide on Kidney Outcomes
Related Resources
Related Articles
Why FLOW's Design Matters, Compared to Earlier Trials
| Trial | Kidney Finding | Real, Key Distinction |
|---|---|---|
| FLOW | 24% reduction in major kidney events | Purpose-built for kidney outcomes, stopped early for efficacy |
| SUSTAIN-6 | Kidney benefit observed | Secondary finding, not the trial's primary purpose |
| LEADER | Kidney benefit observed | Secondary finding, not the trial's primary purpose |
See DietApp's SUSTAIN-6 and LEADER trial pages for the earlier, secondary kidney findings that led researchers to design FLOW as a dedicated, purpose-built trial.
Frequently Asked Questions
Why was FLOW stopped early? A prespecified interim analysis found the efficacy was already clear enough that continuing was no longer necessary to establish the result.
Does this apply to weight-management use of semaglutide too? FLOW specifically studied participants with type 2 diabetes and existing chronic kidney disease; this specific approval doesn't automatically extend to other populations.
Is a 24% reduction a real, meaningful number? Yes, in a trial stopped early for clear efficacy, this represents a genuine, statistically significant clinical benefit.
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About DietApp.com
DietApp.com combines evidence-based GLP-1 medication education with practical treatment tracking tools. The information on DietApp.com is intended for educational purposes only and should not replace professional medical advice, diagnosis, or treatment.
Last medically reviewed and updated: July 11, 2026.
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