Obesity
Conditions
Brief summary
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.
Interventions
DRUGCagrilintide
Cagrilintide will be administered subcutaneously.
DRUGSemaglutide
Semaglutide will be administered subcutaneously.
DRUGTirzepatide
Tirzepatide will be administered subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To confirm non-inferiority of CagriSema versus tirzepatide: Relative change in body weight | From baseline (week 0) to end of treatment (week 84) | Measured in percentage (%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To confirm superiority of CagriSema versus tirzepatide: Relative change in body weight | From baseline (week 0) to end of treatment (week 84) | Measured in percentage (%). |
| Achievement of greater than or equal to (≥) 25% weight reduction | From baseline (week 0) to end of treatment (week 84) | Count of participants. |
| Achievement of ≥ 30% weight reduction | From baseline (week 0) to end of treatment (week 84) | Count of participants. |
| Change in waist circumference | From baseline (week 0) to end of treatment (week 84) | Measured in centimeter (cm). |
| Change in systolic blood pressure (SBP) | From baseline (week 0) to end of treatment (week 84) | Measured in millimeter of mercury (mmHg). |
| Change in diastolic blood pressure (DBP) | From baseline (week 0) to end of treatment (week 84) | Measured in mmHg. |
| Relative change in lipids: Total cholesterol | From baseline (week 0) to end of treatment (week 84) | Measured in percentage. |
| Relative change in lipids: High-density lipoprotein (HDL) cholesterol | From baseline (week 0) to end of treatment (week 84) | Measured in percentage. |
| Relative change in lipids: Non-HDL cholesterol | From baseline (week 0) to end of treatment (week 84) | Measured in percentage. |
| Relative change in lipids: Low-density lipoprotein (LDL) cholesterol | From baseline (week 0) to end of treatment (week 84) | Measured in percentage. |
| Relative change in lipids: Very low-density lipoprotein (VLDL) cholesterol | From baseline (week 0) to end of treatment (week 84) | Measured in percentage. |
| Relative change in lipids: Triglycerides | From baseline (week 0) to end of treatment (week 84) | Measured in percentage. |
| Number of Treatment-emergent Adverse Events (TEAEs) | From baseline (week 0) to end of study (week 90) | Count of events. |
| Number of Treatment Emergent Serious adverse events (TESAEs) | From baseline (week 0) to end of study (week 90) | Count of events. |
Countries
United States
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed