A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3502970 in Japanese Participants with Type 2 Diabetes Mellitus - J2A-JE-GZGB

Wakayama Naohiko0 个研究点目标入组 65 人开始时间: 2021年11月11日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Males and females not of childbearing potential
•-Have type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year
•-Have glycated hemoglobin (HbA1c) value >= 7.0% and <= 10.0% for participants treated with diet and exercise or HbA1c >= 6.5% and <= 9.0% for participants who have washed out antidiabetic medications at screening
•-Have type 2 diabetes controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (OAM); either metformin, DPP-4 (dipeptidyl peptidase-4) inhibitor, or SGLT2 (sodium-glucose co-transporter-2) inhibitor within 3 months prior to screening. Participants must withdraw from their OAM treatment for at least 28 days prior to dosing.

•-Have type 1 diabetes mellitus or latent autoimmune diabetes in adults.
•-Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization
•-Have had an episode of severe hypoglycemia, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery or have a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
•-Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of > 500 milligram per deciliter (mg/dL).
•-Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) greater than 3x upper limit of normal (ULN).

发起方

Wakayama Naohiko