Trial abstract · §2
SOUL — 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 |
|---|---|---|---|
| Semaglutide, oral | 4,305 | 44.6 % | Intervention at the dose reached after titration |
| Placebo | 5,345 | 55.4 % | Matched placebo, administered on the same schedule |
| Randomised total 9,650 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. United States · Canada · United Kingdom · Germany · Sweden · Netherlands · Belgium · France · Spain · Italy · Poland · Israel · Republic of Korea · Taiwan · Mexico · Argentina · South Africa.
§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 as for subcutaneous semaglutide. 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-0019/2 · https://compoundevidence.com/trials/soul/design/ · retrieved 30 July 2026