Novo Nordisk Investigational Site
Fukuoka, 812-0025, Japan
NCT Number: NCT04878406
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.
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Notify Me20 year–55 year
Male
Interventional
Phase 1
Fukuoka, 812-0025, Japan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: From time of dosing (day 1) until completion of the follow-up visit (day 43)
Count of events
Time frame: From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
Measured in nmol*h/L
Time frame: From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
Measured in nmol/L
Time frame: From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
Measured in nmol*h/L
Time frame: From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
Measured in nmol/L
Novo Nordisk A/S
Industry
Investigation of Safety, Tolerability and Pharmacokinetics of Subcutaneously Co-administered Single Doses of NNC0480-0389 and Semaglutide in Healthy Japanese Male Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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