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

Phase 1

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: JPRN-jRCT2051210029
• Lead Sponsor: Wakayama Naohiko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 66

Inclusion 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

Exclusion 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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified