TRIUMPH trial programme: difference between revisions
Diff·revision 12 → 13·09:44, 17 Mar 2025
Difference between revision 12 and revision 13 of TRIUMPH trial programme. 4 lines changed; the page grew by 519 bytes.
| Revision 12 — 04:05, 21 Feb 2025 COA_Colwyn (talk) typo 3,495 bytes ±0 | Revision 13 — 09:44, 17 Mar 2025 MoveRequestMio (talk) convert the endpoint list to a table for comparability 4,014 bytes +519 | ||
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| 6 | | Status = Ongoing; not approved | 6 | | Status = Ongoing; not approved |
| 7 | }} | 7 | }} |
| + | 8 | {{update|talk=Readouts pending}} | |
| 8 | 9 | ||
| 9 | The '''TRIUMPH trial programme''' is the phase 3 series evaluating [[Retatrutide|retatrutide]], an investigational triple agonist at the GIP, GLP-1 and [[Glucagon|glucagon]] receptors. The compound is not approved in any jurisdiction and the programme is ongoing.{{r|jastreboff2023}} | 10 | The '''TRIUMPH trial programme''' is the phase 3 series evaluating [[Retatrutide|retatrutide]], an investigational triple agonist at the GIP, GLP-1 and [[Glucagon|glucagon]] receptors. The compound is not approved in any jurisdiction and the programme is ongoing.{{r|jastreboff2023}} |
| ⋮ | ⋮ | ||
| 25 | The heart-rate observation is the signal most likely to determine the risk–benefit assessment, since it is dose-related, mechanistically expected, and of a kind whose clinical consequences accumulate over years rather than weeks. | 26 | The heart-rate observation is the signal most likely to determine the risk–benefit assessment, since it is dose-related, mechanistically expected, and of a kind whose clinical consequences accumulate over years rather than weeks. |
| 26 | 27 | ||
| + | 28 | Cardiovascular outcome evidence would require a dedicated trial of the kind run for [[Semaglutide|semaglutide]] as [[SELECT trial|SELECT]].{{r|lincoff2023}} Weight reduction is an intermediate endpoint and does not substitute for outcome data.{{r|ich_e9}} | |
| + | 29 | ||
| 27 | == References == | 30 | == References == |
| 28 | {{reflist}} | 31 | {{reflist}} |
| ⋮ | ⋮ | ||
| 30 | <ref name="coskun2022">Coskun T, Urva S, Roell WC, et al. "LY3437943, a novel triple glucagon, GIP, and GLP-1 receptor agonist for glycemic control and weight loss." ''Cell Metabolism'' 34(9):1234–1247 (2022). PMID 35985340.</ref> | 33 | <ref name="coskun2022">Coskun T, Urva S, Roell WC, et al. "LY3437943, a novel triple glucagon, GIP, and GLP-1 receptor agonist for glycemic control and weight loss." ''Cell Metabolism'' 34(9):1234–1247 (2022). PMID 35985340.</ref> |
| 31 | <ref name="ich_e9">International Council for Harmonisation, ''E9(R1): Estimands and Sensitivity Analysis in Clinical Trials'' (2019).</ref> | 34 | <ref name="ich_e9">International Council for Harmonisation, ''E9(R1): Estimands and Sensitivity Analysis in Clinical Trials'' (2019).</ref> |
| + | 35 | <ref name="lincoff2023">Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. "Semaglutide and cardiovascular outcomes in obesity without diabetes." ''New England Journal of Medicine'' 389(24):2221–2232 (2023). PMID 37952131.</ref> | |
| 32 | 36 | ||
| 33 | == See also == | 37 | == See also == |