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

SUMMIT — results

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

Document identifier
CEI-TR-0035/3
Series
Trial abstract
Version
1.0
Published
07 Mar 2024
Last reviewed
07 Apr 2025
Next review
07 Apr 2027
Identifier
10.71829/cei.trial.35
Certainty
Moderate
Cycle
2024 Q1
Phase
Phase 3
Status
Reported

§3Results

§3.1Primary endpoint

Table 3. Primary endpoint as reported.

EndpointResult as reportedCertainty
Time to first occurrence of cardiovascular death or a worsening heart-failure event, and change in the Kansas City Cardiomyopathy Questionnaire clinical summary scoreHazard ratio 0.62 (95 % CI 0.41 to 0.95) for the composite; clinical summary score difference 6.9 points (95 % CI 3.3 to 10.6)Moderate
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 Tirzepatide 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
Nausea29.09.5SURMOUNT-1 (15 mg, 72 weeks)
Diarrhoea23.47.3SURMOUNT-1
Constipation11.75.8SURMOUNT-1
Vomiting12.82.6SURMOUNT-1
Dyspepsia9.12.9SURMOUNT-1
Injection-site reaction5.60.9SURMOUNT-1
Alopecia5.41.0SURMOUNT-1
Cholelithiasis1.60.4SURMOUNT-1
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