REDEFINE 9-study to see how different doses of CagriSema help people -excess body weight lose weight
Research type
Research Study
Full title
Efficacy and safety of cagrilintide s.c. in combination with semaglutide s.c.(CagriSema s.c. 1.0 mg/1.0 mg and 1.7 mg/1.7 mg) once-weekly in participants with overweight or obesity.
IRAS ID
1009583
Contact name
Clinical Transparency
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2023-509273-24
Clinicaltrials.gov Identifier
Research summary
The number of people living with excess weight has been increasing in the last 30 years. People living with excess body weight are more likely to get diseases like type 2 diabetes, increased blood pressure and diseases of the heart. Excess body weight is treated with diet and physical activity, but this does not result in weight loss for all people. Some people may need treatment for excess body weight on top of lifestyle changes to lose weight. The study medicine CagriSema is a combination of two medicines named cagrilintide and semaglutide, which may help people to lose weight.
The purpose of this study is to compare how well different doses of a medicine called CagriSema can help people to lose weight compared to a dummy medicine (also called placebo). The two strengths of CagriSema will be 1.7mg/1.7mg and 1.0mg/1.0mg.
The study will take place in 6 NHS hospitals. The studies main phase amounts to a total of 77 weeks (up to 3 weeks of screening, 68 weeks of treatment and 6 weeks follow-up) .
Participants will attend 13 clinic visits and 8 phone/ video calls with the study staff. Various assessments will be undertaken during the study.REC name
London - Westminster Research Ethics Committee
REC reference
24/LO/0155
Date of REC Opinion
2 May 2024
REC opinion
Further Information Favourable Opinion