The SUSTAIN-6 Trial: Semaglutide's Cardiovascular Evidence
TRIAL-000006
Part of the DietApp.com GLP-1 Trial Database, a comprehensive, regularly reviewed resource.
What It Is
SUSTAIN-6, Trial to Evaluate Cardiovascular and Other Long-Term Outcomes with Semaglutide in Subjects with Type 2 Diabetes, is the trial that established cardiovascular evidence for injectable semaglutide (Ozempic). It enrolled 3,297 participants (1,648 on semaglutide, 1,649 on placebo) with type 2 diabetes at high cardiovascular risk, with a median follow-up of 2.1 years.
Key Results
SUSTAIN-6 showed a reduction in major adverse cardiovascular events, cardiovascular death, non-fatal heart attack, and non-fatal stroke, with semaglutide compared to placebo. A pooled analysis with LEADER also found semaglutide and liraglutide together reduced albuminuria, a marker of kidney damage, by 24% compared to placebo at two years.
A Nuance Worth Knowing
Post-hoc analysis found some statistical heterogeneity in semaglutide's effect on major cardiovascular events based on a participant's baseline BMI, though this finding was described as nominal, meaning it should be interpreted cautiously and doesn't overturn the trial's overall positive result. Researchers concluded the cardiovascular and kidney benefits likely don't meaningfully depend on a patient's starting BMI, though they noted further study was warranted.
References
- PMC: Effects of Liraglutide and Semaglutide on Cardiovascular and Renal Outcomes, LEADER and SUSTAIN 6
- ScienceDirect: Post Hoc Analysis of SUSTAIN 6 and PIONEER 6, Kidney Function
Related Resources
Related Articles
How SUSTAIN-6 Fits Into Semaglutide's Broader Evidence Base
| Trial | Medication | Population | Real Focus |
|---|---|---|---|
| SUSTAIN-6 | Semaglutide | T2D, high CV risk | Cardiovascular safety and benefit |
| LEADER | Liraglutide | T2D, high CV risk | Cardiovascular safety and benefit |
| FLOW | Semaglutide | T2D with existing CKD | Purpose-built kidney outcomes |
| SELECT | Semaglutide | Obesity, no diabetes required | Cardiovascular approval basis |
See DietApp's LEADER trial page for the pooled kidney analysis mentioned above, FLOW for the dedicated kidney outcomes trial that followed, and SELECT for how this evidence extended to a non-diabetes population.
Frequently Asked Questions
Does the BMI-related finding mean semaglutide works differently based on weight? No, researchers described it as a nominal, statistically cautious finding that doesn't overturn the trial's overall positive result.
How is SUSTAIN-6 different from SELECT? SUSTAIN-6 required type 2 diabetes with high cardiovascular risk; SELECT extended the cardiovascular evidence to people with obesity but without diabetes.
What does "albuminuria reduction" actually mean for kidney health? It's a real, measurable marker of reduced kidney damage, though FLOW later provided more definitive, purpose-built kidney outcome evidence.
Explore More
Explore the full GLP-1 Tracker knowledge base on DietApp.com
Get Started
Download DietApp.com to track your own progress alongside the evidence behind your treatment.
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.
sustain-6-trial-semaglutide