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Evidence digest · maintained document

STEP 8 — trial digest

Maintainers: customs_ledger, journalclub_wren, mira.patel Last updated 25 February 2026 Next review due 13 January 2027 334 words · 6 revisions
Sourced from a discussion. This document was promoted out of Non-inferiority margins: how they are chosen and how they are abused, in Trials. That topic links back here, and corrections raised there flow into this page.

STEP 8 (JAMA 2022): How does weekly semaglutide compare directly with daily liraglutide?

Citation and design

FieldValue
TrialSTEP 8
InterventionSemaglutide 2.4 mg weekly versus liraglutide 3.0 mg daily
PublicationJAMA, 2022 (first author Rubino)
DesignRandomised, open-label for the comparator schedule, 68 weeks
PopulationAdults with overweight or obesity without diabetes

This digest summarises the trial and the criticisms our journal club considered material. It is not a substitute for the paper, and where the two differ the paper is right.

The question it set out to answer

How does weekly semaglutide compare directly with daily liraglutide?

Stating the question before the result is a house convention. A great many arguments about this trial are actually arguments about what it was for.

What it found

The cleanest available head-to-head between a weekly and a daily agent in obesity, with both at their licensed obesity doses.

Semaglutide produced greater mean weight reduction. Discontinuation patterns differed between arms.

A useful trial for the argument that the class is not homogeneous.

Criticisms the journal club considered material

  1. Different dosing schedules cannot be fully blinded, and expectation effects in a weight-loss trial are not negligible.
  2. Adherence to a daily injectable is systematically worse than to a weekly one, which is part of the comparison rather than a confounder to be removed — but it does mean the trial compares strategies as much as molecules.

These are criticisms of the design and of how the result is used, not of the investigators. Sessions that lose that distinction get moderated.

How it is misused

The two recurring misuses of this trial in general discussion are quoting the relative effect without the absolute one, and extending the result to a population the trial did not enrol. Both are easy to correct and both keep happening.

Where a number appears in secondary coverage without an estimand attached, assume it is whichever version is larger and check the paper.

Maintenance

Digests are reviewed when new analyses of the same trial are published, and at the review date shown above regardless. If a secondary publication changes the picture, raise it in journal club rather than editing the digest directly, so the change is discussed before it lands.

Revision history

2026-02-25w.novakCorrected a unit label in the second table — it read mg where it should have read mg/mL.
2025-10-26compounding_ruthRestructured into shorter sections so the outline navigation is usable.
2025-10-02ppm_errorSplit an overlong section in two and gave the second a proper heading.
2025-07-28buffer_sheetReverted an unsourced change and asked the editor to re-apply it with a citation.
2025-04-25KTurkingtonAdded cross-references to the two topics that most often ask this question.
2024-12-10revision_historyInitial promotion from the source topic. Structure taken from the marked solution.

Every edit to a maintained document records its author and a note explaining the change. An edit without a note may be reverted by any wiki editor under R9, and the revert is logged. Disagreements about content belong on the source topic rather than in the revision history (R10).

Related documents

  • STEP 1 — trial digestSTEP 1 (N Engl J Med 2021): Does semaglutide 2.4 mg weekly reduce body weight in adults with obesity and no diabetes?
  • STEP 2 — trial digestSTEP 2 (Lancet 2021): What weight reduction does semaglutide 2.4 mg achieve in people who also have type 2 diabetes?
  • STEP 3 — trial digestSTEP 3 (JAMA 2021): What does semaglutide add on top of intensive behavioural therapy?
  • STEP 4 — trial digestSTEP 4 (JAMA 2021): What happens if you stop after reaching the maintenance dose?
  • SUSTAIN 6 — trial digestSUSTAIN 6 (N Engl J Med 2016): Is semaglutide cardiovascular-safe in high-risk type 2 diabetes, and is there benefit?