Status:
COMPLETED
A Study of LY3437943 in Japanese Participants With Type 2 Diabetes Mellitus (T2DM)
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20-70 years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to learn about the side effects of LY3437943 when given to Japanese participants with type 2 diabetes mellitus. Blood tests will be performed to investigate how the b...
Eligibility Criteria
Inclusion
- 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
- 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 3× upper limit of normal (ULN).
Key Trial Info
Start Date :
May 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2022
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04823208
Start Date
May 24 2021
End Date
June 23 2022
Last Update
August 22 2022
Active Locations (4)
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1
Medical Corporation Heishinkai OCROM Clinic
Suita-shi, Osaka, Japan, 565-0853
2
P-one clinic
Hachiōji, Tokyo, Japan, 192-0071
3
Clinical Research Hospital Tokyo
Shinjuku-ku, Tokyo, Japan, 162-0053
4
Yokohama Minoru Clinic
Yokohama, Japan, 232-0064