A Study of LY3437943 in Japanese Participants With Type 2 Diabetes Mellitus (T2DM)

JRCT ID: jRCT2051210029

Registered date:25/05/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 Diabetes Mellitus
• Date of first enrollment: 25/06/2021
• Target sample size: 66
• Study type: Interventional

Intervention(s)

LY3437943 administered subcutaneously (SC)
Placebo administered SC

Outcome(s)

• Primary Outcome: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 70age old
• Gender: Both

Include criteria

-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 lead-in and screening
-Have a body mass index (BMI) within the range 23 to 35 kilograms per square meter (kg/m2), inclusive, and a body weight of at least 54 kilograms (Kg).
-Males and females not of childbearing potential

Exclude criteria

-Have type 1 diabetes mellitus (T1DM)
-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).

Related Information

• Primary Sponsor: Wakayama Naohiko
• Secondary ID(s): NCT04823208