Independent · non-commercial · publishes on a quarterly cycle|Current cycle 2026 Q3
Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Trial abstract · §3

STEP-4 — results

Primary endpoint, absolute and relative effect where derivable, and harms as reported.

Document identifier
CEI-TR-0004/3
Series
Trial abstract
Version
3.1
Published
24 Jan 2023
Last reviewed
24 Feb 2024
Next review
24 Feb 2026
Identifier
10.71829/cei.trial.4
Certainty
High
Cycle
2023 Q1
Phase
Phase 3
Status
Reported

§3Results

§3.1Primary endpoint

Table 3. Primary endpoint as reported.

EndpointResult as reportedCertainty
Percentage change in body weight from week 20 to week 68 after randomised withdrawalContinued 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 consolidatedHigh
Reproduced from the published report. Where the report states a confidence interval the Institute reproduces it; where it does not, none is constructed.

§3.2Endpoint hierarchy

Categorical responder proportionsProportion of participants reaching each categorical response threshold, by arm.ThresholdSemaglutideComparator≥ 5 % reduction70.1 %26.9 %≥ 10 % reduction35.0 %4.4 %≥ 15 % reduction11.0 %1.0 %≥ 20 % reduction2.8 %1.0 %
Figure 1. Illustrative. Categorical responder proportions derived by the Institute from the reported mean change under a logistic response model. These are not the published responder proportions for this trial. The figure is published because a mean conceals the distribution of response, and the shape of that distribution is what a reader most often wants and least often gets.

§3.3Harms as reported

Table 5. Adverse events for Semaglutide from the safety tables the Institute holds for this compound. Where a row names a different trial as its source, the figure is from that trial and not from this one.

EventActive, %Comparator, %Source trial
Nausea44.217.4STEP 1 (68 weeks, 2.4 mg)
Diarrhoea31.515.9STEP 1
Vomiting24.86.6STEP 1
Constipation23.49.5STEP 1
Dyspepsia9.63.9STEP 1
Abdominal pain10.05.6STEP 1
Cholelithiasis2.61.2STEP 1
Acute pancreatitis0.20.1SELECT (mean 39.8 months)
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