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

NCT05669755 · Active, not recruiting

Last updated 2026-05-28

This clinical trial is testing the effects of the medication CagriSema in adults with cardiovascular disease to see if it helps prevent heart attacks, strokes, or death from heart-related causes.

Status Active, not recruiting Ongoing, but no longer enrolling new participants.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 7,101 people

Who can join Ages 55+ · all sexes

Timeline Started 2023-03 · est. completion 2027-10

Where 631 sites · Argentina, Australia, Brazil, Bulgaria, Canada, Colombia, Denmark, France, Germany, India, Ireland, Italy, Japan, Malaysia, Mexico, Netherlands, Poland, Puerto Rico, Serbia, South Africa, Spain, Thailand, Turkey (Türkiye), United Kingdom, United States

What this study is testing ClinicalTrials.gov NCT05669755 ↗

Description as written by the study sponsor.

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. Participant's chance of getting CagriSema or placebo is the same. Participants will inject the study medicine once a week. The study medicine will be injected briefly with a thin needle, typically in the stomach, thighs or upper arms. The study will last for up to 4.5 years.

Treatments tested

Cagrilintide Drug

Participants will receive cagrilintide s.c. once-weekly after a dose escalation period of 16 weeks for 219 weeks.
Semaglutide Drug

Participants will receive semaglutide s.c. once-weekly after a dose escalation period of 16 weeks for 219 weeks.
Placebo Drug

Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide subcutaneously.

Main thing measured	Time to first occurrence of 3-point major adverse cardiovascular event (MACE), a composite endpoint consisting of: cardiovascular (CV) death, non-fatal myocardial infarction, non-fatal stroke
Sponsor	Novo Nordisk A/S
Conditions studied	Cardiovascular Disease
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05669755 ↗