Trial abstract · §2
SUMMIT — design and population
Design, allocation, arms and the population enrolled.
§2Design and population
§2.1Design and allocation
- Design class
- Randomised, double-blind, placebo-controlled, parallel-group
- Masking
- Double-blind (participant, investigator and sponsor)
- Arms
- 2
- Allocation
- Randomised between the intervention and its comparator
- Endpoint adjudication
- Not applicable to the primary endpoint of this design
- Data monitoring
- As specified in the protocol
§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 | 347 | 47.5 % | Intervention at the dose reached after titration |
| Placebo | 384 | 52.5 % | Matched placebo, administered on the same schedule |
| Randomised total 731 as published. Arm-level splits are reconstructed and are not published figures. | |||
§2.3Population
Indications. Heart failure with preserved ejection fraction and obesity · Obesity and overweight in adults
Symptomatic heart failure with a left ventricular ejection fraction of 50 % or above, occurring with obesity as a dominant phenotypic driver.
Geographic footprint. Canada · France · Italy · Poland · Israel · Brazil · Mexico · China.
§2.4Eligibility as the Institute reads it
- Included. Symptomatic heart failure with a left ventricular ejection fraction of 50 % or above, occurring with obesity as a dominant phenotypic driver.
- 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-0035/2 · https://compoundevidence.com/trials/summit/design/ · retrieved 30 July 2026