Obesity
Conditions
Brief summary
This study will look at how well CagriSema helps people with excess body weight lose weight. CagriSema is a new medicine developed by Novo Nordisk that combines cagrilintide and semaglutide. CagriSema cannot yet be prescribed by doctors. In the study, participant will either get CagriSema or dummy medicine and which treatment participant get is decided by chance. The study will last for about 1½ years for each participant.
Interventions
DRUGCagrilintide
Participants will receive once-weekly cagrilintide subcutaneously.
DRUGSemaglutide
Participants will receive once-weekly semaglutide subcutaneously.
DRUGPlacebo
Participants will receive once-weekly placebo matched to cagrilintide and semaglutide subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female * Age above or equal to 18 years at the time of signing informed consent 1. Body Mass index (BMI) greater than or equal to (≥) 30.0 kilogram per meter square (kg/m\^2) or 2. BMI ≥27.0 kg/m2 with the presence of at least one obesity related complication including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in body weight | From baseline (week 0) to end of treatment (week 68) | Measured in percentage (%). |
| Achievement of ≥5% weight reduction | From baseline (week 0) to end of treatment (week 68) | Measured as count of participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Achievement of ≥10% weight reduction | From baseline (week 0) to end of treatment (week 68) | Measured as count of participant. |
| Achievement of ≥15% weight reduction | From baseline (week 0) to end of treatment (week 68) | Measured as count of participant. |
| Achievement of ≥20% weight reduction | From baseline (week 0) to end of treatment (week 68) | Measured as count of participant. |
| Change in waist circumference | From baseline (week 0) to end of treatment (week 68) | Measured in centimeter (cm). |
| Change in systolic blood pressure | From baseline (week 0) to end of treatment (week 68) | Measured in millimeters of mercury. |
| Ratio to baseline in lipids: Total cholesterol | From baseline (week 0) to end of treatment (week 68) | Measured in ratio. |
| Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol | From baseline (week 0) to end of treatment (week 68) | Measured in ratio. |
| Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol | From baseline (week 0) to end of treatment (week 68) | Measured in ratio. |
| Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol | From baseline (week 0) to end of treatment (week 68) | Measured in ratio. |
| Ratio to baseline in lipids: Triglycerides | From baseline (week 0) to end of treatment (week 68) | Measured in ratio. |
| Ratio to baseline in lipids: Free fatty acids | From baseline (week 0) to end of treatment (week 68) | Measured in ratio. |
| Number of treatment emergent adverse events (TEAEs) | From baseline (week 0) to end of study (week 74) | Measured as count of events. |
| Number of treatment emergent serious adverse events (TESAEs) | From baseline (week 0) to end of study (week 74) | Measured as count of events. |
Countries
Canada, France, Germany, United Kingdom, United States
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed