STEP-4 — structured trial abstract
STEP-4 — Semaglutide in obesity: randomised withdrawal
§1Structured abstract
§1.1Objective
To evaluate Semaglutide in obesity and overweight in adults, against the comparator specified in §2, with the primary endpoint stated below.
§1.2Design
- Design
- Randomised withdrawal after an open-label lead-in
- Masking
- Double-blind after the open-label lead-in
- Phase
- Phase 3
- Randomised participants
- 803
- Duration of the primary analysis period
- 48 weeks after a 20-week run-in
- Sponsor class
- Manufacturer-sponsored
- Registry identifier
- not reproduced — see the note in §1.5
§1.3Primary endpoint
Percentage change in body weight from week 20 to week 68 after randomised withdrawal
§1.4Principal result
Continued treatment −7.9 % versus +6.9 % after switching to placebo; the Institute reads this as evidence that the effect is maintained by continued exposure and not consolidated.[1]
§1.5Provenance of this abstract
Table 1. Field-by-field provenance. The Institute records which fields are extracted from a source and which are its own reconstruction, so that a reader can tell the two apart without leaving the page.
| Field | Provenance | Note |
|---|---|---|
| Design, phase, duration, primary endpoint | Extracted | Reproduced from the published report or the registry record. |
| Randomised participants | Extracted | Reproduced as published. |
| Principal result | Extracted | Reproduced as published, with the confidence interval where the Institute holds it. |
| Centres, countries and baseline characteristics | Reconstructed | Derived by the Institute from the design class and the randomised total. Presented in §2 as an illustrative operational profile and marked as such. These figures are not published characteristics of this trial. |
| Certainty assessment | Institute judgement | The Institute’s own domain-by-domain assessment, with reasoning recorded against each domain in §4. |
| Registry identifier | Not held | The Institute does not reproduce a registry identifier it has not verified and never constructs one. Documents are referenced by the Institute’s own identifier. |
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Rubino D, Abrahamsson N, Davies M, Hesse D, Greenway FL, Jensen C, Lingvay I, Mosenzon O, Rosenstock J, Rubio MA, Rudofsky G, Tadayon S, Wadden TA, Dicker D. Effect of continued weekly subcutaneous semaglutide vs placebo on weight loss maintenance in adults with overweight or obesity: the STEP 4 randomized clinical trial. JAMA 2021;325(14):1414–1425. doi:10.1001/jama.2021.3224 · PMID 33755728
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.