Obesity, Overweight
Conditions
Brief summary
This study is being done to find out how well a medicine called CagriSema helps people with overweight or obesity lose weight. CagriSema is still being tested in studies and is not yet available for doctors to prescribe. In this study the sponsor will compare two version of CagriSema injected by two different types of injection devices. Which treatment participants get is decided by chance using a computer program, so neither participants nor study staff will know which treatment is given. The study will last for about one year.
Interventions
DRUGCagrisema
Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously using device 1 or device 2.
Placebo matched to Cagrilintide and Placebo matched to Semaglutide will be administered subcutaneously using device 1 or device 2.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female (sex at birth) * Age 18 years or above at the time of signing the informing consent. * Body Mass Index (BMI) is greater than or equal to (\>= ) 30.0 kilograms per square metre (kg/m\^2) or BMI \>= 27.0 kg/m\^2 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
* Glycosylated 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. * Previous exposure to CagriSema in a clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in body weight | From baseline (week 0) to end of treatment (week 44) | Measured in percentage (%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of TEAEs (treatment emergent adverse events) | From baseline (week 0) to end of study (week 51) | Measured in count of events. |
| Number of TESAEs (Treatment emergent serious adverse events) | From baseline (week 0) to end of study (week 51) | Measured in count of events. |
Countries
Bulgaria, Denmark, Greece, Hungary, Malaysia, Poland, Portugal, Romania, Slovakia, South Africa, Switzerland, Taiwan, Thailand, United States
Contacts
STUDY_DIRECTORClinical Transparency dept. 2834
Novo Nordisk A/S
Outcome results
None listed