4608: REDEFINE 1 - CagriSema effect in people with obesity
Research type
Research Study
Full title
Protocol Title: Efficacy and safety of cagrilintide s.c. 2.4 mg in combination with semaglutide s.c. 2.4 mg (CagriSema s.c. 2.4 mg/2.4 mg) once-weekly in participants with overweight or obesity
IRAS ID
1005591
Contact name
Clinical Transparency Dept. 2834
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2020-005435-75
Clinicaltrials.gov Identifier
Research summary
Obesity is currently one of the most significant public health challenges. People with obesity can have multiple immediate serious diseases or conditions. The risk of obesity-related complications and concurrent diseases/conditions increases with increasing body mass index (BMI), and a body weight loss of 5–10% has been shown to have significant health benefits in individuals with obesity.
The purpose of this study is to evaluate the effect and safety of a once-weekly administered subcutaneous (s.c) medicine called CagriSema in people living with obesity. It will be compared to placebo and 2 other medicines called cagrilintide and semaglutide. CagriSema is a combination of cagrilintide and semaglutide, which have different modes of action. Combining anti-obesity medications with different modes of action has the potential of becoming a new preferable option in the treatment of obesity due to its added benefits on body weight reduction.
The study consists of a main phase which amounts to a total of 78 weeks (up to 3 weeks screening, 68 weeks treatment and 7 weeks follow-up) followed by an extension phase (97 weeks). Only participants randomised to either CagriSema or placebo will continue in the extension phase. During the extension phase, participants will not receive study intervention diet and physical activity counselling or investigational medicinal product) and be considered off-treatment. The purpose of having an extension phase is to obtain a better understanding of the impact of withdrawing investigational medicinal product on weight, cardiovascular risk factors and glucose in people living with overweight or obesity.
Participants will attend 15 clinic visits and 11 phone/ video calls in the main phase and 4 clinics visits and 1 phone call in the extension phase. Various assessments will be undertaken during the course of the study.REC name
East of England - Essex Research Ethics Committee
REC reference
22/EE/0154
Date of REC Opinion
18 Aug 2022
REC opinion
Further Information Favourable Opinion