TRIUMPH trial programme: difference between revisions
Diff·revision 4 → 5·01:19, 22 Oct 2024
Difference between revision 4 and revision 5 of TRIUMPH trial programme. 3 lines changed; the page grew by 524 bytes.
| Revision 4 — 08:35, 14 Oct 2024 LeanMassLars (talk) add the trial acronym expansion at first use 1,956 bytes ±0 | Revision 5 — 01:19, 22 Oct 2024 FiveOhThreeA (talk) add the confidence interval to the point estimate 2,480 bytes +524 | ||
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| 10 | The programme follows a phase 2 obesity trial that reported mean weight change of −24.2% at 48 weeks at the highest dose against −2.1% for placebo. Phase 2 effect sizes in this field have not always been reproduced at phase 3 scale, and this article will require revision as the programme reports.{{r|jastreboff2023}} | 10 | The programme follows a phase 2 obesity trial that reported mean weight change of −24.2% at 48 weeks at the highest dose against −2.1% for placebo. Phase 2 effect sizes in this field have not always been reproduced at phase 3 scale, and this article will require revision as the programme reports.{{r|jastreboff2023}} |
| 11 | 11 | ||
| + | 12 | Trials in the programme span obesity with and without type 2 diabetes and several related conditions, with durations longer than the 68- and 72-week designs of the earlier obesity programmes — a design choice consistent with a phase 2 weight curve that had not plateaued.{{r|coskun2022}} | |
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| 12 | == What phase 2 established == | 14 | == What phase 2 established == |
| 13 | The phase 2 trial randomised adults with obesity to placebo or one of several retatrutide doses, with escalation over 24 weeks and treatment to 48 weeks. Reported mean weight change ran from −8.7% at the lowest dose to −24.2% at the highest.{{r|jastreboff2023}} | 15 | The phase 2 trial randomised adults with obesity to placebo or one of several retatrutide doses, with escalation over 24 weeks and treatment to 48 weeks. Reported mean weight change ran from −8.7% at the lowest dose to −24.2% at the highest.{{r|jastreboff2023}} |
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| 18 | {{reflist}} | 20 | {{reflist}} |
| 19 | <ref name="jastreboff2023">Jastreboff AM, Kaplan LM, Frías JP, et al. "Triple-hormone-receptor agonist retatrutide for obesity — a phase 2 trial." ''New England Journal of Medicine'' 389(6):514–526 (2023). DOI:10.1056/NEJMoa2301972. PMID 37366315.</ref> | 21 | <ref name="jastreboff2023">Jastreboff AM, Kaplan LM, Frías JP, et al. "Triple-hormone-receptor agonist retatrutide for obesity — a phase 2 trial." ''New England Journal of Medicine'' 389(6):514–526 (2023). DOI:10.1056/NEJMoa2301972. PMID 37366315.</ref> |
| + | 22 | <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> | |
| 20 | <ref name="ich_e9">International Council for Harmonisation, ''E9(R1): Estimands and Sensitivity Analysis in Clinical Trials'' (2019).</ref> | 23 | <ref name="ich_e9">International Council for Harmonisation, ''E9(R1): Estimands and Sensitivity Analysis in Clinical Trials'' (2019).</ref> |
| 21 | 24 |