Cardiometabolic & kidneyTrial design
Design and baseline characteristics of the cagrilintide-semaglutide (CagriSema) cardiovascular outcomes trial (REDEFINE 3)
- double-blind, randomized, placebo-controlled trial
- 575 sites in 24 countries
- design and baseline characteristics report
Study context
- Population
- Adults with established cardiovascular disease (CVD) and body mass index (BMI) ≥25.0 kg/m² with/without T2Dadults randomized between 1/2023–12/2024
- Participants
- 7,076 adults
- Planned comparison
- CagriSema compared with placebo on MACE-3 and MACE-4
No results yet. This paper sets out the design of a trial; its results are to come.
Baseline
Baseline characteristics
- Mean age
- 66 years
- BMI ≥30 kg/m²
- 76% of participants (n=5370)
- Participants with T2D
- n=4348, 61%
- Mean duration of T2D, among participants with T2D
- 12 years
- Mean glycated hemoglobin, among participants with T2D
- 7.7%
- Prior myocardial infarction
- n=4369, 62%
- Prior stroke
- n=1311, 19%
- Peripheral arterial disease
- n=769, 11%
- More than one qualifying CVD criteria
- 617 participants (9%)
Original publication
Design and baseline characteristics of the CagriSema cardiovascular outcomes trial (REDEFINE 3). Am Heart J. Published 6 October 2026. doi:10.1016/j.ahj.2026.107626
Summarised from the published abstract; every number is checked against it