TRIUMPH trial programme: difference between revisions
Diff·revision 2 → 3·19:37, 27 Sep 2024
Difference between revision 2 and revision 3 of TRIUMPH trial programme. 6 lines changed; the page grew by 739 bytes.
| Revision 2 — 04:23, 21 Sep 2024 DataTableDunja (talk) rm the cross-trial comparison; the populations are not comparable 1,217 bytes ±0 | Revision 3 — 19:37, 27 Sep 2024 EpitalonEoin (talk) add the discontinuation rate for adverse events in both arms 1,956 bytes +739 | ||
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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 | == 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}} | |
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| + | 15 | A phase 2 trial is powered for dose selection rather than for effect estimation, so the confidence intervals around the larger figures are wide and the point estimates are the least reliable part of the result. This is a general property of phase 2 rather than a criticism of this trial.{{r|ich_e9}} | |
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| 12 | == References == | 17 | == References == |
| 13 | {{reflist}} | 18 | {{reflist}} |
| 14 | <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> | 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> |
| + | 20 | <ref name="ich_e9">International Council for Harmonisation, ''E9(R1): Estimands and Sensitivity Analysis in Clinical Trials'' (2019).</ref> | |
| 15 | 21 | ||
| 16 | {{DEFAULTSORT:TRIUMPH trial programme}} | 22 | {{DEFAULTSORT:TRIUMPH trial programme}} |