Active Not Recruiting
PHASE3
INTERVENTIONAL
NCT05669755
REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
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.
Interventions
Name:
Cagrilintide
Type:
DRUG
Description:
Participants will receive cagrilintide s.c. once-weekly after a dose escalation period of 16 weeks for 219 weeks.
Name:
Semaglutide
Type:
DRUG
Description:
Participants will receive semaglutide s.c. once-weekly after a dose escalation period of 16 weeks for 219 weeks.
Name:
Placebo
Type:
DRUG
Description:
Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide subcutaneously.
Primary Outcomes
Measure:
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
TimeFrame:
From baseline (week 0) to end of study (up to 242 weeks or more)
Description:
Measured in days.
Trial Information
NCT ID
NCT05669755
Status
Active Not Recruiting
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Novo Nordisk A/S
Last Updated
December 15, 2025