Obesity, Overweight
Conditions
Brief summary
The aim of this study is to look at how the study medicine behaves in the participant's body and how it is removed from the participant's body. The study compares Japanese and Caucasian people who are normal weight, overweight or with obesity. The participants will either get NNC0174-0833 (a potential new medicine) or placebo (a dummy medicine similar to the study medicine but without active ingredients) - which treatment any participant gets is decided by chance. Participants will get 1 injection by a study nurse at the clinic. The injection will be with a needle in a skin fold in the participant's stomach area. The study will last for about 4 months, but duration of participation for any participant will last up to about 2 months. The participants will have 8 clinic visits with the study staff.
Interventions
DRUGNNC0174-0833
Participants will receive dose levels of 0.3, 0.9 or 1.8 mg of NNC0174-0833 subcutaneously. Each participant will receive only one dose.
Participants will receive NNC0174-0833 matched placebo subcutaneously.
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.
Intervention model description
Participants will be randomised to 1 of 6 treatment arms, in 3 receiving active NNC0174-0833 and 3 receiving placebo. For statistical analysis and reporting of results, data from the 3 placebo arms will be pooled.
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Male, aged 18-55 years (both inclusive) at the time of signing informed consent. * For Japanese subjects, both parents of Japanese descent and both paternal and maternal grandparents of Japanese descent. * For Caucasian subjects, self-reported European descent or white Latin-American descent. * Body mass index (BMI) between 20.0 and 39.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator. * Body weight between 60 and 110 kg (both inclusive) at screening
Exclusion criteria
* Male subject who is not surgically sterilised (vasectomy) and is sexually active (with female partner\[s\] of childbearing potential), who is not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index less than 1%), or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product. * Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-∞,AM833: the area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after single dose | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | Measured in h\*nmol/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax,AM833: the maximum concentration of NNC0174-0833 in plasma | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | Measured in nmol/L |
| Number of treatment emergent adverse events (TEAEs) | From time of first dosing (Day 1) until completion of the post-treatment follow-up visit (Day 36) | Count of events |
Countries
United States
Outcome results
None listed