4896: REIMAGINE 2 - treatment of type 2 diabetes with cargrilintide and semagutide combination
Research type
Research Study
Full title
Efficacy and safety of co-administered cagrilintide and semaglutide (CagriSema) s.c. in doses 2.4/2.4 mg and 1.0/1.0 mg once weekly versus semaglutide 2.4 mg and 1.0 mg, cagrilintide 2.4 mg and placebo in participants with type 2 diabetes inadequately controlled on metformin with or without an SGLT2 inhibitor
IRAS ID
1008115
Contact name
Clinical Transparency
Contact email
Sponsor organisation
Novo Nordisk A/S
Research summary
Type 2 diabetes is a disease where the blood sugar is not properly controlled due to a reduced production of insulin and/or an impaired response to insulin in the body. People with type 2 diabetes have a higher risk of other diseases like heart diseases. Keeping a low blood sugar level and body weight may reduce the risk of getting these diseases. Therefore, people with type 2 diabetes need treatment to lower their blood sugar.
In this study are looking at how the new medicine called CagriSema may lower blood sugar and body weight in people with type 2 diabetes. CagriSema is a new medicine that is being developed by the company Novo Nordisk A/S and is a combination of cagrilintide and semaglutide. Cagrilintide and semaglutide have both shown positive effects on blood sugar regulation and weight loss, so in combination CargriSema may help people with type 2 diabetes to control blood sugar better and lose more weight than cagrilintide and semaglutide alone.
Participants being asked to take part have type 2 diabetes, with a BMI of at least 25kg/m2, and high blood sugar with their current treatment for type 2 diabetes. This is planned to be conducted in 32 countries, with approximately 357 sites.
2700 participants will be randomly given either
- CagriSema (1.0 mg or 2.4 mg)
- semaglutide (1.0 mg or 2.4 mg)
- cagrilintide (2.4 mg)
- “dummy” medicine
subcutaneously (injection under the skin) once a week, while continuing with their current diabetes medicine ( metformin with or without an SGLT2 inhibitor).
The study includes a screening period to assess the participants eligibility, a 68 - week treatment period and a 7-week follow up period. Participants will have various assessments undertaken, attend 17-19 clinic visits and 8-10 phone calls whilst participating in the study. The total study duration for each participant will be approximately 78 weeks.REC name
London - Chelsea Research Ethics Committee
REC reference
23/LO/0502
Date of REC Opinion
31 Aug 2023
REC opinion
Further Information Favourable Opinion