This study looks at how the new medicine called NNC0480-0389 works in the body of Japanese men when it is given together with semaglutide. Participants will get NNC0480-0389 and semaglutide or 2 doses of placebo - which treatment participants get is decided by chance. NNC0480-0389 is a new medicine that has not been previously approved. It means that the medicine has not yet been approved by the health authorities. Semaglutide is a newly approved antidiabetic medicine that helps to lower blood sugar levels in patients with type 2 diabetes. NNC0480-0389 is being developed to be given together with semaglutide.NNC0480-0389 targets a different part of the system that regulates sugar levels in the body than semaglutide. Therefore, it is expected that together NNC0480-0389 and semaglutide will more effectively lower sugar levels in the blood. Participants will get 2 injections of the study medicine. It will be injected with a needle into a skin fold on participants' stomach. The study will last for a maximum of 72 days. Participants will have 10 scheduled visits with the study doctor. For 1 of the visits participants will stay at the clinic for 6 days (5 nights).The study includes blood sampling.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
A single dose of subcutaneous NNC0480-0389. The study will last for a maximum of 72 days.
A single dose of subcutaneous placebo (NNC0480-0389) The study will last for a maximum of 72 days.
A single dose of subcutaneous Semaglutide 0.5 mg The study will last for a maximum of 72 days.
A single dose of subcutaneous placebo (semaglutide) The study will last for a maximum of 72 days.
Novo Nordisk Investigational Site
Fukuoka, Japan
Number of treatment emergent adverse events (TEAEs)
Count of events
Time frame: From time of dosing (day 1) until completion of the follow-up visit (day 43)
AUC0-∞,NNC0480-0389,SD: Area under the NNC0480-0389 plasma concentration-time curve from time 0 to infinity upon a single-dose
Measured in nmol\*h/L
Time frame: From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
Cmax,NNC0480-0389,SD: Maximum plasma concentration of NNC0480-0389 upon a single-dose
Measured in nmol/L
Time frame: From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
AUC0-∞,semaglutide,SD: Area under the semaglutide plasma concentration-time curve from time 0 to infinity upon a single-dose
Measured in nmol\*h/L
Time frame: From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
Cmax,semaglutide,SD: Maximum plasma concentration of semaglutide upon a single-dose
Measured in nmol/L
Time frame: From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
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