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健康な日本人男性におけるセマグルチドと併用した薬剤NNC0480-0389の体内での作用に関する研究

基本情報

NCT ID
NCT04878406
ステータス
完了
試験のフェーズ
第1相
試験タイプ
介入
目標被験者数
24
治験依頼者名
Novo Nordisk A/S

概要

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.

対象疾患

Healthy Volunteers Type 2 Diabetes

介入

Semaglutide(DRUG)
NNC0480-0389(DRUG)
Placebo (NNC0480-0389)(DRUG)
Placebo (Semaglutide)(DRUG)

依頼者(Sponsor)