Indication assessment · §3
Atherosclerotic cardiovascular disease and cardiovascular risk reduction — trial records
Trial records in the Institute's register bearing on atherosclerotic cardiovascular disease and cardiovascular risk reduction.
§3Trials in this indication
71 trial records in the Institute's register bear on this indication, of which 15 are published trials.
Table 2. Trial records bearing on atherosclerotic cardiovascular disease and cardiovascular risk reduction.
| Record | Compound | Phase | Design | Randomised | Year |
|---|---|---|---|---|---|
| SELECT | Semaglutide | Phase 3 | Event-driven cardiovascular outcome trial | 17,604 | 2023 |
| SUSTAIN-6 | Semaglutide | Phase 3 | Event-driven cardiovascular outcome trial | 3,297 | 2016 |
| PIONEER-6 | Semaglutide, oral | Phase 3 | Event-driven cardiovascular outcome trial | 3,183 | 2019 |
| SOUL | Semaglutide, oral | Phase 3 | Event-driven cardiovascular outcome trial | 9,650 | 2025 |
| SURPASS-4 | Tirzepatide | Phase 3 | Randomised, open-label, active-controlled | 2,002 | 2021 |
| SURPASS-CVOT | Tirzepatide | Phase 3 | Event-driven cardiovascular outcome trial | 13,299 | 2025 |
| SYNCHRONIZE-CVOT | Survodutide | Phase 3 | Event-driven cardiovascular outcome trial | — | — |
| LEADER | Liraglutide | Phase 3 | Event-driven cardiovascular outcome trial | 9,340 | 2016 |
| REWIND | Dulaglutide | Phase 3 | Event-driven cardiovascular outcome trial | 9,901 | 2019 |
| EXSCEL | Exenatide | Phase 3 | Event-driven cardiovascular outcome trial | 14,752 | 2017 |
| ELIXA | Lixisenatide | Phase 3 | Event-driven cardiovascular outcome trial | 6,068 | 2015 |
| AMPLITUDE-O | Exenatide | Phase 3 | Event-driven cardiovascular outcome trial | 4,076 | 2021 |
| HARMONY-OUTCOMES | Dulaglutide | Phase 3 | Event-driven cardiovascular outcome trial | 9,463 | 2018 |
| EMBRACE-STEMI | Exenatide | Phase 2 | Randomised, double-blind, placebo-controlled | 91 | 2016 |
| TB4-PH1-CARDIAC | Thymosin beta-4 | Phase 1 | Phase 1 ascending dose | — | 2012 |
| SUSTAIN-6-BODY-COMPprogramme record | Semaglutide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2016 |
| PIONEER-6-BIOMARKERprogramme record | Semaglutide, oral | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2019 |
| SURPASS-4-PKprogramme record | Tirzepatide | Phase 1 | Phase 1 ascending dose | — | 2021 |
| SURPASS-CVOT-PKprogramme record | Tirzepatide | Phase 1 | Phase 1 ascending dose | — | 2025 |
| SYNCHRONIZE-CVOT-RENAL-IMPprogramme record | Survodutide | Phase 1 | Phase 1 ascending dose | — | — |
| SELECT-ADHERENCEprogramme record | Semaglutide | Phase 3 | Observational | — | 2023 |
| SOUL-RENAL-IMPprogramme record | Semaglutide, oral | Phase 1 | Phase 1 ascending dose | — | 2025 |
| LEADER-OLEprogramme record | Liraglutide | Phase 3 | Single-arm open-label | — | 2016 |
| REWIND-REGIONAL-JPprogramme record | Dulaglutide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2019 |
| ELIXA-DDIprogramme record | Lixisenatide | Phase 1 | Randomised crossover | — | 2015 |
| EXSCEL-REGIONAL-CNprogramme record | Exenatide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2017 |
| AMPLITUDE-O-REGIONAL-JPprogramme record | Exenatide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2021 |
| HARMONY-OUTCOMES-BODY-COMPprogramme record | Dulaglutide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2018 |
| EMBRACE-STEMI-HEPATIC-IMPprogramme record | Exenatide | Phase 1 | Phase 1 ascending dose | — | 2016 |
| TB4-PH1-CARDIAC-REGIONAL-CNprogramme record | Thymosin beta-4 | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2012 |
| SUSTAIN-6-REGIONAL-JPprogramme record | Semaglutide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2016 |
| PIONEER-6-ADHERENCEprogramme record | Semaglutide, oral | Phase 3 | Observational | — | 2019 |
| SURPASS-4-RENAL-IMPprogramme record | Tirzepatide | Phase 1 | Phase 1 ascending dose | — | 2021 |
| SURPASS-CVOT-RENAL-IMPprogramme record | Tirzepatide | Phase 1 | Phase 1 ascending dose | — | 2025 |
| SYNCHRONIZE-CVOT-PKprogramme record | Survodutide | Phase 1 | Phase 1 ascending dose | — | — |
| SOUL-PKprogramme record | Semaglutide, oral | Phase 1 | Phase 1 ascending dose | — | 2025 |
| LEADER-ELDERLYprogramme record | Liraglutide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2016 |
| ELIXA-HEPATIC-IMPprogramme record | Lixisenatide | Phase 1 | Phase 1 ascending dose | — | 2015 |
| EXSCEL-QOLprogramme record | Exenatide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2017 |
| AMPLITUDE-O-BODY-COMPprogramme record | Exenatide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2021 |
| HARMONY-OUTCOMES-REGIONAL-JPprogramme record | Dulaglutide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2018 |
| EMBRACE-STEMI-DDIprogramme record | Exenatide | Phase 1 | Randomised crossover | — | 2016 |
| TB4-PH1-CARDIAC-QOLprogramme record | Thymosin beta-4 | Phase 1 | Randomised, double-blind, placebo-controlled | — | 2012 |
| SUSTAIN-6-REGIONAL-CNprogramme record | Semaglutide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2016 |
| PIONEER-6-OLEprogramme record | Semaglutide, oral | Phase 3 | Single-arm open-label | — | 2019 |
| SURPASS-4-HEPATIC-IMPprogramme record | Tirzepatide | Phase 1 | Phase 1 ascending dose | — | 2021 |
| SOUL-DDIprogramme record | Semaglutide, oral | Phase 1 | Randomised crossover | — | 2025 |
| LEADER-BIOMARKERprogramme record | Liraglutide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2016 |
| REWIND-QOLprogramme record | Dulaglutide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2019 |
| ELIXA-RENAL-IMPprogramme record | Lixisenatide | Phase 1 | Phase 1 ascending dose | — | 2015 |
| EXSCEL-BODY-COMPprogramme record | Exenatide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2017 |
| AMPLITUDE-O-QOLprogramme record | Exenatide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2021 |
| HARMONY-OUTCOMES-REGIONAL-CNprogramme record | Dulaglutide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2018 |
| EMBRACE-STEMI-PKprogramme record | Exenatide | Phase 1 | Phase 1 ascending dose | — | 2016 |
| TB4-PH1-CARDIAC-BODY-COMPprogramme record | Thymosin beta-4 | Phase 1 | Randomised, double-blind, placebo-controlled | — | 2012 |
| SUSTAIN-6-QOLprogramme record | Semaglutide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2016 |
| PIONEER-6-ELDERLYprogramme record | Semaglutide, oral | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2019 |
| SURPASS-4-DDIprogramme record | Tirzepatide | Phase 1 | Randomised crossover | — | 2021 |
| SURPASS-CVOT-DDIprogramme record | Tirzepatide | Phase 1 | Randomised crossover | — | 2025 |
| SOUL-HEPATIC-IMPprogramme record | Semaglutide, oral | Phase 1 | Phase 1 ascending dose | — | 2025 |
| REWIND-REGIONAL-CNprogramme record | Dulaglutide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2019 |
| ELIXA-PKprogramme record | Lixisenatide | Phase 1 | Phase 1 ascending dose | — | 2015 |
| AMPLITUDE-O-REGIONAL-CNprogramme record | Exenatide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2021 |
| HARMONY-OUTCOMES-QOLprogramme record | Dulaglutide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2018 |
| EMBRACE-STEMI-RENAL-IMPprogramme record | Exenatide | Phase 1 | Phase 1 ascending dose | — | 2016 |
| TB4-PH1-CARDIAC-REGIONAL-JPprogramme record | Thymosin beta-4 | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2012 |
| PIONEER-6-REGIONAL-JPprogramme record | Semaglutide, oral | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2019 |
| LEADER-QOLprogramme record | Liraglutide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2016 |
| REWIND-BIOMARKERprogramme record | Dulaglutide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2019 |
| HARMONY-OUTCOMES-ADHERENCEprogramme record | Dulaglutide | Phase 3 | Observational | — | 2018 |
| EMBRACE-STEMI-REGIONAL-CNprogramme record | Exenatide | Phase 3 | Randomised, double-blind, placebo-controlled | — | 2016 |
| This facet in the trial register. | |||||
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.
- Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Riesmeyer JS, Riddle MC, Rydén L, Xavier D, Atisso CM, Dyal L, Hall S, Rao-Melacini P, Wong G, Avezum A, Basile J, Chung N, Conget I. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. The Lancet 2019;394(10193):121–130. doi:10.1016/S0140-6736(19)31149-3 · PMID 31189511
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.
Compound Evidence Institute · CEI-IN-03/3 · https://compoundevidence.com/indications/cvd/trials/ · retrieved 30 July 2026