Independent · non-commercial · publishes on a quarterly cycle|Current cycle 2026 Q3
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Compound Evidence InstituteEvidence synthesis · established 2023Graded assessments of compounds, trials, methods and supply
Document set current to 30 July 2026
Trial abstract · §3

REDEFINE-1 — results

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

Document identifier
CEI-TR-0049/3
Series
Trial abstract
Version
2.1
Published
12 Jan 2025
Last reviewed
12 Jan 2026
Next review
12 Jan 2028
Identifier
10.71829/cei.trial.49
Certainty
Moderate
Cycle
2025 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 baseline to week 68Mean change −22.7 % versus −2.3 % with placeboModerate
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.ThresholdCagriSema (cagrilintide with semaglutide)Comparator≥ 5 % reduction97.0 %26.9 %≥ 10 % reduction97.0 %4.4 %≥ 15 % reduction90.6 %1.0 %≥ 20 % reduction68.9 %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 CagriSema (cagrilintide with 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.

EventActive, %Comparator, %Source trial
Nausea——Combination gastrointestinal burden is broadly the sum of the component profiles rather than additive beyond it
Vomiting——Reported at higher incidence than semaglutide monotherapy in cross-trial comparison, which the Institute notes is not a randomised comparison
Discontinuation for adverse events6.03.0REDEFINE 1 (approximate)
Compound Evidence Institute · CEI-TR-0049/3 · https://compoundevidence.com/trials/redefine-1/results/ · retrieved 30 July 2026
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