4942 REDEFINE 3 CagriSema cardiovascular outcomes trial in participants with obesity
Research type
Research Study
Full title
The cardiovascular safety 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 obesity and established cardiovascular disease
IRAS ID
1006625
Contact name
Clinical Transparency (Dept. 2834)
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2021-005855-35
Clinicaltrials.gov Identifier
Research summary
Obesity is currently one of the most significant and widespread health challenges. People living with obesity are at a high risk of obesity-related complications one of which is cardiovascular disease. Cardiovascular disease affects people’s heart and blood vessels leading to heart attacks, strokes or poor blood circulation.
The purpose of this study is to evaluate the effect and safety on the cardiovascular system of a once-weekly injectable medicine called CagriSema in people living with obesity and established cardiovascular disease. Cagrisema is a new medicine that is being developed by the company Novo Nordisk A/S and is a combination of cagrilintide and semaglutide. These medicines work in different ways in the body and have the potential to help treat obesity and impact cardiovascular risk factors.
The study includes a screening period to assess participants' eligibility, a 156-week treatment period and a 7-week follow-up period. The total study duration for each participant will be 163 weeks which equals approximately 3 years. Participants will be asked to attend up to 22 clinic visits throughout the whole study. During the treatment period, participants will take either CagriSema or placebo and will receive regular diet and physical activity counselling. Various assessments will be undertaken during the study.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
22/NE/0217
Date of REC Opinion
28 Feb 2023
REC opinion
Further Information Favourable Opinion