Overweight and Obesity
Conditions
Brief summary
The aim of this study is to look at how the study medicine behaves in participants body and how it is removed from their body. The study compares three different doses of the study medicine in Chinese healthy men. Participant will either get 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833 which dose participant get is decided by chance. NNC0174-0833 is a new medicine and has not been approved by the Center for Drug Evaluation. We are testing the study medicine to make a medicine that can help people lose weight. Participant will get 1 injection by a study nurse or doctor at the clinic. The injection will be with a needle in a skin fold in the stomach area. The study will last for about 5 months. But participants participation will last about 2 months. Participant will have 8 clinic visits with the study staff. One of these visits will be a 7-day, 6-night stay. At all visits, except the information visit, participant will have blood drawn along with other clinical examinations. Participants will be asked about their health, medical history and habits including mental health.
Interventions
DRUGNNC0174 0833
Participants will either get a single dose of 0.3 mg, 0.9 mg or 1.8 mg NNC0174-0833, administered subcutaneously (s.c., under the skin)
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
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key inclusion criteria * Chinese male subject aged 18-55 years (both inclusive) at the time of signing informed consent. * Body mass index (BMI) between 20.0 and 39.9 kg/m\^2 (both inclusive) at screening. * Body weight between 60.0 and 110.0 kg (both inclusive) at screening. Key
Exclusion criteria
* Male subject who is not sexually abstinent or surgically sterilised (vasectomy) or who or whose partner(s) is not willing to use highly effective contraceptive methods (as required by local regulation or practice) throughout the trial (until 'end of trial'). * 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-∞, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to infinity after a single dose | From pre-dose (Day 1) to Visit 7 (Day 36) | measured in h·nmol/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax, NNC0174-0833: The maximum concentration of NNC0174-0833 in plasma | From pre-dose (Day 1) to Visit 7 (Day 36) | measured in nmol/L |
| tmax, NNC0174-0833: The time from dose administration to maximum plasma concentration of NNC0174-0833 | From pre-dose (Day 1) to Visit 7 (Day 36) | measured in hours |
| t1/2, NNC0174-0833: The terminal half-life of NNC0174-0833 | From pre-dose (Day 1) to Visit 7 (Day 36) | measured in hours |
| AUC0-168, NNC0174-0833: The area under the NNC0174-0833 plasma concentration-time curve from time 0 to 168 hours after a single dose | From pre-dose (Day 1) to Visit 3 (Day 8) | measured in h·nmol/L |
| Vz/FNNC0174-0833: The apparent volume of distribution of NNC0174-0833 in the terminal phase | From pre-dose (Day 1) to Visit 7 (Day 36) | measured in L |
| Change in body weight | From pre-dose (Day 1) to Visit 7 (Day 36) | measured in percentage |
| CL/FNNC0174-0833: The apparent total plasma clearance of NNC0174-0833 | From pre-dose (Day 1) to Visit 7 (Day 36) | measured in L/h |
Countries
China
Outcome results
None listed