FLOW: A Research Study to See How Semaglutide Works Compared to Placebo in People with Type 2 Diabetes and Chronic Kidney Disease

Background + significance

FLOW added kidney protection to the established semaglutide cardiovascular benefit in T2D. Trial was stopped early for efficacy. Major impact on nephrology + endocrinology guideline recommendations for GLP-1 in T2D + CKD.

Trial design

Sponsor

Novo Nordisk

Phase

Phase 3

Participants

3,533

Duration

170 weeks

ClinicalTrials.gov ID

NCT03819153

Drugs tested

• Ozempic (semaglutide 1.0 mg)Active

Primary outcome

Time to first major kidney disease event (composite: kidney failure, ≥50% eGFR decline, kidney death, CV death)

24% relative reduction in primary composite on semaglutide vs placebo (HR 0.76, 95% CI 0.66-0.88; P<0.001)

Secondary outcomes

• •Slowed eGFR decline by 1.16 mL/min/1.73m² per year
• •Reduced CV death (HR 0.71)
• •Reduced all-cause mortality (HR 0.80)

Why it matters

1. 1.First demonstration of GLP-1 kidney protection in a pre-specified primary outcome.
2. 2.Trial stopped early for efficacy — strong effect size.
3. 3.Expanded clinical role of semaglutide in T2D with CKD.