TRIUMPH trial programme: difference between revisions
Diff·revision 9 → 10·22:00, 11 Jan 2025
Difference between revision 9 and revision 10 of TRIUMPH trial programme. 6 lines changed; the page grew by 559 bytes.
| Revision 9 — 11:57, 30 Dec 2024 KarlFischerKit (talk) add the DOI 2,837 bytes ±0 | Revision 10 — 22:00, 11 Jan 2025 NNT_Nerys (talk) state the analysis population: intention-to-treat or per-protocol 3,396 bytes +559 | ||
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| 1 | {{Infobox concept | 1 | {{Infobox concept |
| 2 | | name = TRIUMPH trial programme | 2 | | name = TRIUMPH trial programme |
| + | 3 | | subtitle = Phase 3 programme | |
| 3 | | Drug = [[Retatrutide|Retatrutide]] | 4 | | Drug = [[Retatrutide|Retatrutide]] |
| 4 | | Indications studied = Obesity, type 2 diabetes, related conditions | 5 | | Indications studied = Obesity, type 2 diabetes, related conditions |
| ⋮ | ⋮ | ||
| 18 | 19 | ||
| 19 | Two dose-related safety observations were reported: a heart-rate increase larger than that typical of GLP-1 monotherapy, and transient rises in fasting glucose at low doses in participants with diabetes. Both are attributable to the glucagon component and are the predicted consequences of the design.{{r|coskun2022}} | 20 | Two dose-related safety observations were reported: a heart-rate increase larger than that typical of GLP-1 monotherapy, and transient rises in fasting glucose at low doses in participants with diabetes. Both are attributable to the glucagon component and are the predicted consequences of the design.{{r|coskun2022}} |
| + | 21 | ||
| + | 22 | == What phase 3 is designed to address == | |
| + | 23 | Phase 3 addresses the questions phase 2 cannot: effect size with adequate precision, safety at the event rates only large trials detect, durability over longer periods, and performance in the populations that will actually use the drug.{{r|ich_e9}} | |
| + | 24 | ||
| + | 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. | |
| 20 | 26 | ||
| 21 | == References == | 27 | == References == |