Trial abstract · §2
SURPASS-CVOT — design and population
Design, allocation, arms and the population enrolled.
§2Design and population
§2.1Design and allocation
- Design class
- Randomised, double-blind, placebo-controlled, event-driven cardiovascular outcome trial
- Masking
- Double-blind with independent endpoint adjudication
- Arms
- 2
- Allocation
- Randomised between the intervention and its comparator
- Endpoint adjudication
- Independent, blinded to assignment
- Data monitoring
- Independent data monitoring committee with access to unblinded accumulating data
§2.2Arms
Table 2. Randomised arms. Illustrative: arm-level allocations are reconstructed by the Institute from the design class and the randomised total where the published report does not state them.
| Arm | Allocated | Share | Description |
|---|---|---|---|
| Tirzepatide | 7,500 | 56.4 % | Intervention at the dose reached after titration |
| Placebo | 5,799 | 43.6 % | Matched placebo, administered on the same schedule |
| Randomised total 13,299 as published. Arm-level splits are reconstructed and are not published figures. | |||
§2.3Population
Indications. Atherosclerotic cardiovascular disease and cardiovascular risk reduction · Type 2 diabetes mellitus
Established atherosclerotic disease of the coronary, cerebral or peripheral arterial beds, or a risk profile sufficient for enrolment in a cardiovascular outcome trial.
Geographic footprint. Germany · Denmark · Sweden · Norway · Finland · France · Spain · Poland · Czechia · Hungary · Israel · Japan · Republic of Korea · New Zealand · Brazil · Mexico · Argentina · South Africa · China.
§2.4Eligibility as the Institute reads it
- Included. Established atherosclerotic disease of the coronary, cerebral or peripheral arterial beds, or a risk profile sufficient for enrolment in a cardiovascular outcome trial.
- Excluded. Participants for whom the intervention is contraindicated, including personal or family history of medullary thyroid carcinoma. Exclusion criteria narrow the population to which the estimate applies and are the principal source of indirectness where a trial estimate is applied to ordinary practice.
Compound Evidence Institute · CEI-TR-0034/2 · https://compoundevidence.com/trials/surpass-cvot/design/ · retrieved 30 July 2026