Trial abstract · §3

STEP-8 — results

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

Document identifier: CEI-TR-0006/3
Series: Trial abstract
Version: 1.0
Published: 06 Mar 2023
Last reviewed: 06 Mar 2024
Next review: 06 Mar 2026
Identifier: 10.71829/cei.trial.6
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 68, semaglutide 2.4 mg versus liraglutide 3.0 mg	Mean change −15.8 % with semaglutide versus −6.4 % with liraglutide; difference −9.4 percentage points (95 % CI −12.0 to −6.8)	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-0006/3 · https://compoundevidence.com/trials/step-8/results/ · retrieved 30 July 2026