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

Conditions

• Cardiovascular Disease

Eligibility Criteria

Sex

ALL

Age

55 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Mar 1, 2023

Status verified

May 2026

Primary completion

Sep 1, 2027

Completion

Oct 13, 2027

Study Design

Enrollment

7,101 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CagriSema
  Participants will receive cagrilintide and semaglutide subcutaneously (s.c.) once-weekly after a dose escalation period of 16 weeks during the maintenance period of 219 weeks.
• Placebo Comparator: Placebo
  Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide s.c. once weekly for 235 weeks.

Primary Outcome 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 [ Time Frame: From baseline (week 0) to end of study (up to 242 weeks or more) ]

Locations (119)

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