Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100730, China
NCT Number: NCT05498610
This study looks at how the new medicine called NNC0480-0389 works in the body of Chinese men when it is given at different doses together with a fixed dose of semaglutide. Participants will get one injection of NNC0480-0389 and one injection of semaglutide - which dose of NNC0480-0389 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 people 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 in people with type 2 diabetes.
Participants will get 2 injections of the study medicine (one of each). It will be injected with a needle into a skin fold on participants abdomen.
The study will last for a maximum of 72 days. Partcicipants 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 Me18 year–55 year
Male
Interventional
Phase 1
Beijing, Beijing Municipality, 100730, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will get 1 injections of NNC04800389. It will be injected with a needle into a skin fold on the abdomen.
The study will last for a maximum of 72 days
Participants will get 1 injections of semaglutide. It will be injected with a needle into a skin fold on the abdomen.
The study will last for a maximum of 72 days
Time frame: From pre-dose (day 1) to completion of the post-dose follow-up visit (day 43)
measured in hnmol^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 hnmol^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 Pharmacokinetic Properties of Subcutaneously co Administered Single Doses of NNC0480-0389 and Semaglutide in Healthy Chinese 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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