Non-alcoholic Fatty Liver Disease
Conditions
Brief summary
This study looks at how a new study medicine called NNC0194-0499 behaves in the body of Chinese men. Three different dose levels will be tested. Participant will get only one of the three different dose levels of NNC0194-0499. Which dose participant will get will be decided by chance. NNC0194-0499 is a medicine under clinical investigation. It means that the medicine has not yet been approved by the health authorities. Participant will get 1 or 2 injections of the study medicine. It will be injected with a needle into a skin fold on stomach. The study will last for a maximum of 64 days. Participant will not be able to take part in the study if the study doctor considers there is a risk for participant's health.
Interventions
DRUGNNC0194-0499
Participants will receive a single s.c. dose of 12 mg NNC0194-0499 on Day 1.
DRUGNC0194-0499
Participants will receive a single s.c. dose of 96 mg NNC0194-0499 on Day 1.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * Chinese male aged 20-55 years (both inclusive) at the time of signing informed consent. * Body mass index (BMI) between 23.0 and 34.9 kilograms per meter square (kg/m\^2) (both inclusive). * Body weight greater than or equal to 60 kg. * Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion criteria
* Known or suspected hypersensitivity to study intervention or related products. * Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-∞, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to infinity after a single dose | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | Measured in nanomoles\*hours per liter (nmol h/L). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax, NNC0194-0499: The maximum concentration of NNC0194- 0499 in serum | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | Measured in nmol/L. |
| tmax, NNC0194-0499: The time from dose administration to maximum serum concentration of NNC0194-0499 | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | Measured in hours. |
| t1/2, NNC0194-0499: The terminal half-life of NNC0194-0499 | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | Measured in hours. |
| CL/FNNC0194-0499: The apparent total serum clearance of NNC0194-0499 | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | Measured in liters per hour (L/h). |
| AUC0-168h, NNC0194-0499: The area under the NNC0194-0499 serum concentration-time curve from time 0 to 168 hours after a single dose | From Day 1 (pre-dose) until Day 7 (168 hours) | Measured in nmol h/L. |
| Relative change in triglycerides | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | Measured in Percent change. |
| Relative change in high-density lipoprotein (HDL) cholesterol | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | Measured in Percent change. |
| Relative change in low-density lipoprotein (LDL) cholesterol | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | Measured in Percent change. |
| Vz/FNNC0194-0499: The apparent volume of distribution of NNC0194-0499 in the terminal phase | From Day 1 (pre-dose) until completion of the post-treatment follow-up visit (Day 36) | Measured in liters (L). |
Countries
China
Outcome results
None listed