A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight
Purpose
This study will look at how well CagriSema compared to Tirzepatide helps people lower their body weight. CagriSema is a new investigational medicine developed by Novo Nordisk that combines Cagrilintide and Semaglutide. CagriSema is not yet being prescribed by doctors. Participant will get injections once a week throughout the treatment period. Participant will inject the study medicine under the skin with a pen injector in the thigh, stomach, or upper arm. After a first low dose, the study medicine will be gradually increased until reaching the planned dose (2.4 mg CagriSema or 15 mg Tirzepatide). The study will last for about one and a half year for each participant.
Condition
- Obesity
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Male or female - Age 18 years or above at the time of signing the informed consent - Body mass index (BMI) of ≥ 30.0 kilogram per square meter (kg/m^2)
Exclusion Criteria
- Glycated haemoglobin (HbA1c) ≥ 6.5 % (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening - History of type 1 or type 2 diabetes mellitus
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental CagriSema 2.4 mg/2.4 mg |
Participants will receive 2.4 mg cagrilintide and 2.4 mg semaglutide subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 84 weeks. |
|
|
Active Comparator Tirzepatide 15 mg |
Participants will receive 15 mg tirzepatide subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 84 weeks. |
|
Recruiting Locations
More Details
- NCT ID
- NCT06131437
- Status
- Active, not recruiting
- Sponsor
- Novo Nordisk A/S