STEP-TEENS — structured trial abstract
STEP-TEENS — Semaglutide in adolescent obesity: randomised, double-blind, placebo-controlled
§1Structured abstract
§1.1Objective
To evaluate Semaglutide in obesity in children and adolescents, against the comparator specified in §2, with the primary endpoint stated below.
§1.2Design
- Design
- Randomised, double-blind, placebo-controlled, parallel-group
- Masking
- Double-blind (participant, investigator and sponsor)
- Phase
- Phase 3
- Randomised participants
- 201
- Duration of the primary analysis period
- 68 weeks
- Sponsor class
- Manufacturer-sponsored
- Registry identifier
- not reproduced — see the note in §1.5
§1.3Primary endpoint
Percentage change in body-mass index from baseline to week 68 in adolescents aged 12 to under 18 years
§1.4Principal result
Mean change −16.1 % versus +0.6 % with placebo; estimated difference −16.7 percentage points (95 % CI −20.3 to −13.2).[1]
Growth, bone accrual and pubertal outcomes beyond 68 weeks were not evaluated, which is the Institute’s principal reason for grading this evidence moderate rather than high.
§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.
- Weghuber D, Barrett T, Barrientos-Pérez M, Gies I, Hesse D, Jeppesen OK, Kelly AS, Mastrandrea LD, Sørrig R, Arslanian S. Once-weekly semaglutide in adolescents with obesity. New England Journal of Medicine 2022;387(24):2245–2257. doi:10.1056/NEJMoa2208601 · PMID 36322838
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.