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

PIONEER-1 — results

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

Document identifier
CEI-TR-0017/3
Series
Trial abstract
Version
3.3
Published
19 Mar 2023
Last reviewed
19 Jan 2024
Next review
19 Jan 2026
Identifier
10.71829/cei.trial.17
Certainty
High
Cycle
2023 Q1
Phase
Phase 3
Status
Reported

§3Results

§3.1Primary endpoint

Table 3. Primary endpoint as reported.

EndpointResult as reportedCertainty
Change in glycated haemoglobin from baseline to week 26 as monotherapyDose-dependent reduction of 0.6 to 1.1 percentage points versus placeboHigh
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

§3.3Harms as reported

Table 5. Adverse events for Semaglutide, oral 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
Nausea20.02.4PIONEER 1 (14 mg, 26 weeks)
Diarrhoea9.02.4PIONEER 1
Vomiting7.01.2PIONEER 1
Decreased appetite7.01.6PIONEER 1
Discontinuation for adverse events7.32.4PIONEER 1
Nausea36.512.2OASIS 1 (50 mg)
Vomiting24.64.2OASIS 1
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