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Human controlled primary / registryStrong with full-text access limitationCompleted; peer reviewed; registry results posted

SURPASS-CVOT cardiovascular outcomes trial

TIRZEPATIDE-STUDY-P085-P086

Nicholls et al. (2025); ClinicalTrials.gov NCT04255433.

Study design

Record details

Design: Randomized, double-blind, active-comparator cardiovascular outcomes trial.
Population or model: People with type 2 diabetes and established atherosclerotic cardiovascular disease.
Material tested: Lilly-manufactured tirzepatide clinical product.
Comparator: Dulaglutide.

Evidence record

Endpoints, findings, and limitations

Endpoints

Three-component major adverse cardiovascular event composite (MACE-3).

Qualified findings

The primary analysis met noninferiority versus dulaglutide; superiority was not established.

Limitations

The primary result was checked in the PubMed abstract and registry. Publisher full text and supplement were not reviewed; no cardiovascular-superiority language or subgroup expansion.

Reports and sources

Reference ledger

P085Human controlled primary; PEER REVIEWED, randomised, double-blind, active comparator; RESULTS POSTED

Nicholls et al. 2025 SURPASS-CVOT

(2025). DOI: 10.1056/NEJMoa2505928
P086Trial registry or protocol; COMPLETED

ClinicalTrials.gov NCT04255433
P095Human controlled primary, pre-specified exploratory analysis; PEER REVIEWED

Zoungas et al. 2026 SURPASS-CVOT kidney analysis

(2026). DOI: 10.1016/S2213-8587(26)00032-X