Trial results

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

NCT05669755 on ClinicalTrials.gov · last registry update 2026-08-31

An unusually large phase 3: 7,101 participants, more than double the 424 typical for the stage. Due to report 1 September 2027. Sponsors move these dates routinely; any movement since this site started watching is listed below. It has been running since 1 March 2023 — 3 years so far. semaglutide is already approved in the US for cardiovascular disease, so this is asking a further question rather than establishing the drug works at all.

Status

ACTIVE_NOT_RECRUITING

Phase

P3

Drug

semaglutide

Rybelsus, Wegovy, Ozempic

Sponsor

Novo Nordisk A/S

Sponsor type

Industry

Enrollment

7,101

Started

2023-03-01

Primary completion

2027-09-01 estimated

Observed history

No changes recorded since monitoring began on 2026-08-21. This record has held steady. If a reporting date moves, a status changes or enrollment is resized, it will appear here with the previous value alongside the new one.

Primary outcome

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

Conditions studied

Cardiovascular Disease

Every field above is taken directly from the registry record. See all detected changes across the class, or the semaglutide page for this molecule’s full trial and approval history.