Cardiovascular outcomes with survodutide in adults with obesity at increased cardiovascular risk (SYNCHRONIZE-CVOT): a double-blind, randomised, placebo-controlled, phase 3 trial
Primary result · Composite of death from cardiovascular causes, non-fatal stroke, non-fatal myocardial infarction, ischaemia-related coronary revascularisation, or heart failure eventResult — go to the resultHazard ratio 0.89 95% CI 0.67–1.18Authors' conclusion
In participants with obesity with established cardiovascular disease or chronic kidney disease or at increased risk of cardiovascular disease, survodutide was not associated with increased risk for the primary composite endpoint of death from cardiovascular causes, non-fatal stroke, non-fatal myocardial infarction, ischaemia-related coronary revascularisation, or heart failure event compared with placebo. This cardiovascular safety trial provides clinicians with reassuring data that treatment with survodutide, a novel glucagon receptor-GLP-1 receptor dual agonist, is not associated with increased cardiovascular risk.
Study context
- Population
- Adults aged 18 years or older with a BMI of 27 kg/m² or greater and established cardiovascular disease or at least two obesity complications or risk factors for cardiovascular disease; participants with chronic kidney disease eligible if BMI of 30 kg/m² or greaterrecruited and randomly assigned, 5507 treated
- Participants
- 5,530 adults
- Comparison
- Pooled survodutide compared with placebo
- SURVODUTIDE 3.6 MGn = 1,836
- SURVODUTIDE 6.0 MGn = 1,835
- SURVODUTIDE (POOLED)n = 3,671
- PLACEBOn = 1,836reference
- Primary endpoint
- Composite of:
- Death from cardiovascular causes
- Non-fatal stroke
- Non-fatal myocardial infarction
- Ischaemia-related coronary revascularisation
- Heart failure event
Methodological detailsnon-inferiority margin of 1.65 for the upper limit of the two-sided 95% CI of the HR, treatment-regimen estimand, 524 clinical sites in 34 countries
- Non-inferiority margin of 1.65 for the upper limit of the two-sided 95% CI of the HR
- Treatment-regimen estimand
- 524 clinical sites in 34 countries
Primary result
As reported in the abstract
Hazard ratio
0.89
95% CI 0.67–1.18
P < 0.0001 for non-inferiority
Events by treatment group
Further findings
| Outcome | SURVODUTIDE 3.6 MG | SURVODUTIDE 6.0 MG | PLACEBO |
|---|---|---|---|
| Study conduct | remained on treatment until study closeout 56.0% | remained on treatment until study closeout 56.6% | remained on treatment until study closeout 59.0% |
- Study conduct — Median time in study
- 22.0 months (IQR 20.1-23.7)
- Study conduct — Participants not treated
- 23 (0.4%)
Safety
| Outcome | SURVODUTIDE 3.6 MG | SURVODUTIDE 6.0 MG | PLACEBO |
|---|---|---|---|
| Adverse events | 93.0% | 93.1% | 85.6% |
| Nausea | 48.0% | 49.0% | 12.1% |
| Vomiting | 31.7% | 34.0% | 4.8% |
| Gastrointestinal adverse events leading to treatment discontinuations | 19.3% | 20.8% | 1.9% |
| Serious adverse events | 22.5% | 20.8% | 23.9% |
| Fatal adverse events | 0.9% | 0.9% | 0.6% |
| Fatal adverse events due to cardiac disorders | 0.3% | 0.4% | 0.3% |
Original publication
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