SELECT — structured trial abstract
SELECT — Semaglutide in cardiovascular and obesity: event-driven cardiovascular outcome trial
§1Structured abstract
§1.1Objective
To evaluate Semaglutide in atherosclerotic cardiovascular disease and cardiovascular risk reduction and obesity and overweight in adults, against the comparator specified in §2, with the primary endpoint stated below.
§1.2Design
- Design
- Randomised, double-blind, placebo-controlled, event-driven cardiovascular outcome trial
- Masking
- Double-blind with independent endpoint adjudication
- Phase
- Phase 3
- Randomised participants
- 17,604
- Duration of the primary analysis period
- Mean 39.8 months
- Sponsor class
- Manufacturer-sponsored
- Registry identifier
- not reproduced — see the note in §1.5
§1.3Primary endpoint
Time to first occurrence of a three-point composite of cardiovascular death, non-fatal myocardial infarction or non-fatal stroke
§1.4Principal result
Hazard ratio 0.80 (95 % CI 0.72 to 0.90); 6.5 % versus 8.0 %.[1,2]
Event-driven, independently adjudicated, and enrolled participants without diabetes. The Institute treats SELECT as the trial that separates the cardiovascular effect of this class from glycaemic control.
§1.5Provenance of this abstract
Table 1. Field-by-field provenance. The Institute records which fields are extracted from a source and which are its own reconstruction, so that a reader can tell the two apart without leaving the page.
| Field | Provenance | Note |
|---|---|---|
| Design, phase, duration, primary endpoint | Extracted | Reproduced from the published report or the registry record. |
| Randomised participants | Extracted | Reproduced as published. |
| Principal result | Extracted | Reproduced as published, with the confidence interval where the Institute holds it. |
| Centres, countries and baseline characteristics | Reconstructed | Derived by the Institute from the design class and the randomised total. Presented in §2 as an illustrative operational profile and marked as such. These figures are not published characteristics of this trial. |
| Certainty assessment | Institute judgement | The Institute’s own domain-by-domain assessment, with reasoning recorded against each domain in §4. |
| Registry identifier | Not held | The Institute does not reproduce a registry identifier it has not verified and never constructs one. Documents are referenced by the Institute’s own identifier. |
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Lincoff AM, Brown-Frandsen K, Colhoun HM, Deanfield J, Emerson SS, Esbjerg S, Hardt-Lindberg S, Hovingh GK, Kahn SE, Kushner RF, Lingvay I, Oral TK, Michelsen MM, Plutzky J, Tornøe CW, Ryan DH. Semaglutide and cardiovascular outcomes in obesity without diabetes. New England Journal of Medicine 2023;389(24):2221–2232. doi:10.1056/NEJMoa2307563 · PMID 37952131
- Ryan DH, Lingvay I, Deanfield J, Kahn SE, Barrientos-Pérez M, Colhoun HM, Cercato C, Conway L, Kushner RF, Lincoff AM. Long-term weight loss effects of semaglutide in obesity without diabetes in the SELECT trial. Nature Medicine 2024;30(7):2049–2057. doi:10.1038/s41591-024-02996-7 · PMID 38740993
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.