REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels

What Was Tested

In this phase 3 trial, researchers set out to test Cagrilintide and Semaglutide.

This study will look at the effects of CagriSema on cardiovascular events (for example heart attack and stroke) in people living with cardiovascular disease.

Participants will either get CagriSema or a dummy medicine (also called "placebo") which has no effect on the body.

Which treatment participants will get will be decided by chance.

It had two arms (groups): CagriSema (experimental) and Placebo (placebo comparator).

Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide s.c. once weekly for 235 weeks.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 7101 actual participants took part.

It was open to people of any sex aged from 55 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female. Age above or equal to 55 years at the time of signing informed consent. Body mass index (BMI) greater than or equal to (\>=) 25.0 kilograms per meter square (kg/m\^2). Established CVD as evidenced by at least one of the following:. Prior myocardial infarction.

The full record lists 17 inclusion and 6 exclusion criteria; among the exclusions: myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 60 days before screening; planned coronary, carotid or peripheral artery revascularisation known on the day of screening; heart failure classified as being in new york heart association (nyha) class iv at screening.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Cagrilintide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Cagrilintide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Cagrilintide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2023-03-01 with completion listed for 2027-09-01.

It ran at 633 sites in United States (119), India (78), Poland (57), Bulgaria (41), Turkey (Türkiye) (36) and Italy (26).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 18 secondary outcomes, for example Time to first occurrence of myocardial infarction (fatal and non-fatal), Time to first occurrence of stroke (fatal and non-fatal), Change in eGFRcr (CKD-EPI), Ratio to baseline in Urine albumin-to-creatinine ratio (UACR), Relative change in body weight and Change in waist circumference.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Cagrilintide and Semaglutide in 7101 people.

With 7101 participants it is a large trial for this field.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cagrilintide compound page and the Semaglutide compound page, all human trials.