Trial abstract · §3

STEP-5 — results

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

Document identifier: CEI-TR-0005/3
Series: Trial abstract
Version: 3.4
Published: 13 Mar 2023
Last reviewed: 13 Sep 2023
Next review: 13 Sep 2025
Identifier: 10.71829/cei.trial.5
Certainty: High
Cycle: 2023 Q1
Phase: Phase 3
Status: Reported

§3Results

§3.1Primary endpoint

Table 3. Primary endpoint as reported.

Endpoint	Result as reported	Certainty
Percentage change in body weight from baseline to week 104	Mean change −15.2 % versus −2.6 % with placebo; the longest randomised exposure in the programme	High
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

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.

Event	Active, %	Comparator, %	Source trial
Nausea	44.2	17.4	STEP 1 (68 weeks, 2.4 mg)
Diarrhoea	31.5	15.9	STEP 1
Vomiting	24.8	6.6	STEP 1
Constipation	23.4	9.5	STEP 1
Dyspepsia	9.6	3.9	STEP 1
Abdominal pain	10.0	5.6	STEP 1
Cholelithiasis	2.6	1.2	STEP 1
Acute pancreatitis	0.2	0.1	SELECT (mean 39.8 months)

Compound Evidence Institute · CEI-TR-0005/3 · https://compoundevidence.com/trials/step-5/results/ · retrieved 30 July 2026