Obesity, Overweight
Conditions
Brief summary
The purpose of this clinical study is to compare 2 different versions cagrilintide and see how these work in people living with excess body weight. Participant will get either cagrilintide B or cagrilintide D injections. Which treatment participant will get is decided by chance. Participant will be in this clinical study for about 14 weeks.
Interventions
DRUGCagrilintide B
Cagrilintide B will be administered subcutaneously.
DRUGCagrilintide D
Cagrilintide D 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
Key Inclusion Criteria: * Age 18-64 years (both inclusive) at the time of signing informed consent. * Male or female (sex assigned at birth). * Body mass index (BMI) between 27.0 and 34.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. * Considered eligible 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. Key
Exclusion criteria
* Previous dosing of marketed or non-marketed amylin-agonists (a). * Any condition, unwillingness or inability which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol (a). 1. As declared by the participant, reported in the medical records or at the investigator's discretion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUCss: area under the total cagrilintide concentration-time curve at steady state after 5th dosing of cagrilintide | From Pre-dose at Day 29 to Day 36 | Measured as hour\*nanomole per liter (h\*nmol/L). |
| Cmax,ss: maximum observed concentration of total cagrilintide at steady state after 5th dosing of cagrilintide | From Pre-dose at Day 29 to Day 36 | Measured as nanomole per liter (nmol/L). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUCss: area under the total cagrilintide concentration-time curve at steady state after 4th dosing of cagrilintide | From Pre-dose at Day 22 to Day 29 | Measured as h\*nmol/L. |
| Cmax,ss: maximum observed concentration of total cagrilintide at steady state after 4th dosing of cagrilintide | From Pre-dose at Day 22 to Day 29 | Measured as nmol/L. |
| AUCss: area under the total cagrilintide concentration-time curve at steady state after 1st dosing of cagrilintide | From Pre-dose at Day 1 to Day 8 | Measured as h\*nmol/L. |
| Cmax,ss: maximum observed concentration of total cagrilintide at steady state after 1st dosing of cagrilintide | From Pre-dose at Day 1 to Day 8 | Measured as nmol/L. |
Countries
United States
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed