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日本人肥満前または肥満の2型糖尿病患者を対象としたMEDI0382の安全性および忍容性に関する研究

基本情報

NCT ID
NCT03645421
ステータス
完了
試験のフェーズ
第2相
試験タイプ
介入
目標被験者数
61
治験依頼者名
AstraZeneca

概要

This is a Phase 2a study designed to assess the safety and tolerability of MEDI0382 titrated up to a dose level of 100, 200 or 300 µg from 50 µg vs Placebo across 48 days in Japanese subjects. The study D5674C00001 can be conducted with a reasonable expectation of safety and tolerability in Japanese T2DM patients. The design of this study has taken into account the known benefits and risks of GLP-1 receptor agonists and glucagon receptor agonists as well as the translatable effects observed in nonclinical studies of MEDI0382.

対象疾患

Type 2 Diabetes

介入

MEDI0382 100 μg(DRUG)
MEDI0382 200 μg(DRUG)
MEDI0382 300 μg(DRUG)
PlaceboA(DRUG)
MEDI0382 50 ug(DRUG)
PlaceboB(DRUG)

依頼者(Sponsor)