NCT05669755

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

The Cardiovascular Safety and Efficacy of Cagrilintide 2.4 mg s.c. in Combination With Semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) Once-weekly in Participants With Established Cardiovascular Disease

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 7,101 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	Cagrilintide	Participants will receive cagrilintide s.c. once-weekly after a dose escalation period of 16 weeks for 219 weeks.
DRUG	Semaglutide	Participants will receive semaglutide s.c. once-weekly after a dose escalation period of 16 weeks for 219 weeks.
DRUG	Placebo	Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide subcutaneously.

Timeline

• Start date: 2023-03-01
• Primary completion: 2027-09-01
• Completion: 2027-10-13
• First posted: 2023-01-03
• Last updated: 2026-03-12

Locations

628 sites across 25 countries: United States, 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

Regulatory

• FDA-regulated drug study