LivingGLP1
Study S000149

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

Registration

Registration
NCT05669755
Acronym
REDEFINE 3
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
QUADRUPLE
Status
ACTIVE_NOT_RECRUITING
Enrollment
7101
Start
2023-03-01
Primary completion
2027-09-01
Lead sponsor
Novo Nordisk A/S
Conditions
Cardiovascular Disease
Interventions
DRUG:Cagrilintide; DRUG:Semaglutide; DRUG:Placebo
Results posted
FALSE
Individual participant data sharing
YES
Secondary identifiers
OTHER:U1111-1270-0943; EUDRACT_NUMBER:2021-005855-35; REGISTRY:jRCT2031220672

Registered primary outcomes

  • 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 [From baseline (week 0) to end of study (up to 242 weeks or more)]

Linked records (1)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0029336Design and baseline characteristics of the CagriSema cardiovascular outcomes trial (REDEFINE 3).
Cavender MA, American heart journal
2026Randomized trialPMID 42838477DOIcites ClinicalTrials.gov:NCT05669755; registry reference DERIVED:42838477