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

LEADER — results

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

Document identifier
CEI-TR-0074/3
Series
Trial abstract
Version
2.3
Published
28 Feb 2023
Last reviewed
28 Dec 2023
Next review
28 Dec 2025
Identifier
10.71829/cei.trial.74
Certainty
High
Cycle
2023 Q1
Phase
Phase 3
Status
Reported

§3Results

§3.1Primary endpoint

Table 3. Primary endpoint as reported.

EndpointResult as reportedCertainty
Time to first major adverse cardiovascular eventHazard ratio 0.87 (95 % CI 0.78 to 0.97)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

Cumulative incidence of the primary endpointCumulative event incidence in each randomised arm over the follow-up period.0510010203040Months since randomisationCumulative incidence (%)LiraglutideComparator
Figure 1. Illustrative. Cumulative incidence of the primary composite, reconstructed by the Institute from the reported hazard ratio and a comparator event rate typical of the enrolled risk profile. The curves are not digitised from the published figure. They are published to convey the shape of event accrual and the point at which the arms separate, and no incidence should be read off them.

Table 4. Relative and absolute effect. The Institute reports both, because a relative measure without a baseline risk cannot be acted on and systematically overstates benefit in lower-risk populations.

MeasureValueNote
Hazard ratio as reported0.87Reproduced from the published report.
Comparator event rate, %10.6Illustrative. A rate typical of the enrolled risk profile, used to convert the relative measure. Not a published figure.
Absolute risk difference, pp1.38Illustrative. Computed from the two rows above.
Number needed to treat72Illustrative. For the stated duration, at the comparator rate assumed above. Rises sharply as baseline risk falls.
Three of the four rows are Institute constructions and are marked. Only the hazard ratio is a published figure.

§3.3Harms as reported

Table 5. Adverse events for Liraglutide 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
Nausea39.313.8SCALE Obesity (3.0 mg, 56 weeks)
Diarrhoea20.99.3SCALE Obesity
Constipation19.48.5SCALE Obesity
Vomiting15.73.9SCALE Obesity
Headache13.612.6SCALE Obesity
Cholelithiasis1.50.5SCALE Obesity
Acute pancreatitis0.30.1SCALE programme pooled
Discontinuation for adverse events9.93.8SCALE Obesity
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