CagriSema cardiovascular outcomes trial REDEFINE 3 randomized 7,076 adults with established CVD

This publication describes the design and baseline characteristics of REDEFINE 3, a trial in humans in which 7,076 adults were randomized. The abstract states that REDEFINE 3 is a double-blind, randomized, placebo-controlled trial involving participants with established cardiovascular disease and a body mass index of 25.0 kg/m2 or higher, with or without type 2 diabetes, assigned to CagriSema or placebo plus standard of care.

The authors describe two prespecified objectives. The safety objective is to confirm noninferiority of CagriSema versus placebo on a composite of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke (MACE-3). The efficacy objective is to confirm superiority on a composite that also includes revascularization (MACE-4).

Randomization took place between January 2023 and December 2024 at 575 sites in 24 countries, according to the abstract. Mean age at baseline was 66 years, and a body mass index of 30 kg/m2 or higher was present in 76% of participants (n=5370).

Type 2 diabetes was present in 4,348 participants (61%), with a mean diabetes duration of 12 years and mean glycated hemoglobin of 7.7%. Most participants had a prior myocardial infarction (n=4369, 62%); prior stroke (n=1311, 19%) and peripheral arterial disease (n=769, 11%) were less common, and 617 participants (9%) met more than one qualifying cardiovascular disease criterion.

The abstract states that participants with established cardiovascular disease and excess adiposity were randomized to CagriSema 2.4 mg/2.4 mg or placebo, plus standard of care. CagriSema is described in the abstract as a fixed-dose combination of cagrilintide and semaglutide administered subcutaneously once weekly. No titration schedule or treatment duration is given in the abstract.

This is a design and baseline-characteristics report, not an outcomes report: the abstract presents no efficacy or safety results, and the authors write that the trial will provide evidence regarding cardiovascular safety and efficacy. Any conclusions about event rates are therefore unavailable at this stage.

Enrollment was restricted to adults with established cardiovascular disease and a body mass index of 25.0 kg/m2 or higher, so the baseline sample does not represent broader populations. The abstract does not state funding, sponsorship, or author affiliations, and does not report adverse events or participant retention.

Cagrilintide, also referred to as AM833 or NNC0174-0833 and studied in combination with semaglutide as CagriSema, is not an FDA-approved drug for any use. This status comes from the site's regulatory review rather than from the paper described here.