Obesity, Overweight
Conditions
Brief summary
This clinical study is testing two versions of the study medicine cagrilintide. The purpose of the study is to compare these two versions to understand their effects in participants with overweight or obesity. Participants will receive either cagrilintide version D or cagrilintide version B, and which treatment participants receive is decided by chance. Participants will be in this clinical study for about 6 months.
Interventions
DRUGCagrilintide D
Cagrilintide D will be administered subcutaneously.
DRUGCagrilintide B and placebo semaglutide I
Cagrilintide B and placebo semaglutide I 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 64 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18-64 years (both inclusive) at the time of signing informed consent * Body mass index (BMI) between 27.0 and 34.9 kilograms per square metre (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. * Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion criteria
* Previous participation in study(s) with an amylin analogue. Participation is defined as randomisation. * Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC,ss: area under the total cagrilintide concentration-time curve at steady state after 5th dosing of cagrilintide s.c. | Day 113 (pre-dose) to Day 120 (post-dose) | Measured in hour nanomoles per litre (h\*nmol/L) |
| Cmax,ss: maximum concentration of total cagrilintide at steady state after 5th dosing of cagrilintide s.c. | Day 113 (pre-dose) to Day 120 (post-dose) | Measured in nanomoles per litre (nmol/L). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| tmax,ss: time since last dosing to maximum concentration of totala cagrilintide at steady state after 5th dosing of cagrilintide s.c. | Day 113 (pre-dose) to Day 120 (post-dose) | Measured in hours. |
| t½,ss: terminal half-life of total cagrilintide at steady state after 5th dosing of cagrilintide s.c. | Day 113 (pre-dose) to Day 162 (post-dose) | Measured in hours. |
| Vz/F: the apparent volume of distribution of total cagrilintide during elimination after the 5th dosing of cagrilintide s.c. | Day 113 (pre-dose) to Day 120 (post-dose) | Measured in litre. |
| CL/F: total apparent clearance of total cagrilintide after the 5th dosing of cagrilintide s.c. | Day 113 (pre-dose) to Day 120 (post-dose) | Measured in litre per hours. |
| AUC,ss: area under the cagrilintide and metabolites concentration-time curve at steady state after the 5th dosing of cagrilintide s.c. | Day 113 (pre-dose) to Day 120 (post-dose) | Measured in hours\*nmol/L. |
| Cmax,ss: maximum concentration of cagrilintide and metabolites at steady state after the 5th dosing of cagrilintide s.c. | Day 113 (pre-dose) to Day 120 (post-dose) | Measured in nmol/L. |
| tmax,ss: time since the last dosing to maximum concentration of cagrilintide and metabolites at steady state after the 5th dosing of cagrilintide s.c. | Day 113 (pre-dose) to Day 120 (post-dose) | Measured in hours. |
| t½,ss: terminal half-life of cagrilintide parent at steady state after the 5th dosing of cagrilintide s.c. | Day 113 (pre-dose) to Day 120 (post-dose) | Measured in hours. |
| AUC,ss: area under the total cagrilintide concentration-time curve at steady state after the 4th dosing of cagrilintide s.c | Day 22 (pre-dose) to Day 29 (post-dose) | Measured in hours\*nmol/L. |
| Cmax,ss: maximum concentration of total cagrilintide at steady state after the 4th dosing of cagrilintide s.c. | Day 22 (pre-dose) to Day 29 (post-dose) | Measured in nmol/L. |
| tmax,ss: time since the last dosing to maximum concentration of total cagrilintide at steady state after the 4th dosing of cagrilintide s.c. | Day 22 (pre-dose) to Day 29 (post-dose) | Measured in hours. |
| Number of treatment-emergent adverse events (TEAEs) | Day 1 (randomisation) to Day 162 (end of study) | Measured in count of events. |
| Number of treatment-emergent serious adverse events (TESAEs) | Day 1 (randomisation) to Day 162 (end of study) | Measured in count of events. |
Countries
Germany
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed