STEP trial programme: difference between revisions
Diff·revision 10 → 11·07:43, 7 Nov 2024
Difference between revision 10 and revision 11 of STEP trial programme. 6 lines changed; the page grew by 585 bytes.
| Revision 10 — 11:12, 23 Oct 2024 SemaglutideSasha (talk) state the non-inferiority margin, since the design was non-inferiority 3,324 bytes ±0 | Revision 11 — 07:43, 7 Nov 2024 TSH_Tallulah (talk) the percentage quoted was placebo-adjusted; label it 3,909 bytes +585 | ||
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| 1 | {{Infobox concept | 1 | {{Infobox concept |
| 2 | | name = STEP trial programme | 2 | | name = STEP trial programme |
| + | 3 | | subtitle = Phase 3 programme | |
| 3 | | image = trial-bars.svg | 4 | | image = trial-bars.svg |
| 4 | | caption = Placebo-adjusted weight change across the principal STEP trials. | 5 | | caption = Placebo-adjusted weight change across the principal STEP trials. |
| ⋮ | ⋮ | ||
| 27 | 28 | ||
| 28 | STEP 4 is the informative one for discontinuation. Participants who reached the maintenance dose during a run-in were randomised either to continue or to switch to placebo; the switched group regained weight steadily thereafter. See [[Weight regain after discontinuation]].{{r|rubino2021}} | 29 | STEP 4 is the informative one for discontinuation. Participants who reached the maintenance dose during a run-in were randomised either to continue or to switch to placebo; the switched group regained weight steadily thereafter. See [[Weight regain after discontinuation]].{{r|rubino2021}} |
| + | 30 | ||
| + | 31 | == Design features that shape the figures == | |
| + | 32 | All the principal trials ran 68 weeks with a 16-week escalation to the maintenance dose, so roughly a quarter of the trial was spent below the studied dose. Effect at 68 weeks is therefore not effect after 68 weeks at 2.4 mg.{{r|wilding2021}} | |
| + | 33 | ||
| + | 34 | Both arms received lifestyle intervention — reduced-calorie diet and increased physical activity, with regular counselling. This is standard for obesity trials and it raises the placebo arm, which is why placebo-arm weight change in these trials is not zero. | |
| 29 | 35 | ||
| 30 | == References == | 36 | == References == |