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

SURMOUNT-4 — results

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

Document identifier
CEI-TR-0024/3
Series
Trial abstract
Version
2.4
Published
18 Jan 2024
Last reviewed
18 May 2024
Next review
18 May 2026
Identifier
10.71829/cei.trial.24
Certainty
High
Cycle
2024 Q1
Phase
Phase 3
Status
Reported

§3Results

§3.1Primary endpoint

Table 3. Primary endpoint as reported.

EndpointResult as reportedCertainty
Percentage change in body weight from week 36 to week 88 after randomised withdrawalContinued treatment −5.5 % versus +14.0 % after switching to 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

Categorical responder proportionsProportion of participants reaching each categorical response threshold, by arm.ThresholdTirzepatideComparator≥ 5 % reduction53.7 %26.9 %≥ 10 % reduction21.0 %4.4 %≥ 15 % reduction5.8 %1.0 %≥ 20 % reduction2.0 %1.0 %
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 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
Nothing published by the Institute is medical advice, a diagnosis, a prescription, a treatment recommendation or a purchasing recommendation. Compounds supplied for research use are not approved for human or veterinary use in any jurisdiction, and a favourable analytical assessment of a supplier is not a statement that any product is safe or effective. The Institute publishes certainty ratings and never recommendations. No telephone number, messaging handle or ordering channel appears anywhere on this site.