STEP-4 — design and population
Design, allocation, arms and the population enrolled.
§2Design and population
§2.1Design and allocation
- Design class
- Randomised withdrawal after an open-label lead-in
- Masking
- Double-blind after the open-label lead-in
- Arms
- 2
- Allocation
- Randomised at the end of an open-label lead-in, among participants who completed it
- Endpoint adjudication
- Not applicable to the primary endpoint of this design
- Data monitoring
- As specified in the protocol
§2.2Arms
Table 2. Randomised arms. Illustrative: arm-level allocations are reconstructed by the Institute from the design class and the randomised total where the published report does not state them.
| Arm | Allocated | Share | Description |
|---|---|---|---|
| Semaglutide | 379 | 47.2 % | Intervention at the dose reached after titration |
| Placebo | 424 | 52.8 % | Matched placebo, administered on the same schedule |
| Randomised total 803 as published. Arm-level splits are reconstructed and are not published figures. | |||
§2.3Population
Indication. Obesity and overweight in adults
Excess adiposity sufficient to impair health, operationalised in the pivotal incretin programmes as a body-mass index of 30 kg/m² or above, or 27 kg/m² or above with at least one weight-related comorbidity.
Geographic footprint. Germany · Sweden · Netherlands · France · Spain · Italy · Israel · Australia.
§2.4Eligibility as the Institute reads it
- Included. Excess adiposity sufficient to impair health, operationalised in the pivotal incretin programmes as a body-mass index of 30 kg/m² or above, or 27 kg/m² or above with at least one weight-related comorbidity.
- Excluded. Participants for whom the intervention is contraindicated, including personal or family history of medullary thyroid carcinoma. Exclusion criteria narrow the population to which the estimate applies and are the principal source of indirectness where a trial estimate is applied to ordinary practice.
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.