A Study of LY3437943 in Japanese Participants With Type 2 Diabetes Mellitus (T2DM)
- Registration Number
- NCT04823208
- Lead Sponsor
- Eli Lilly and Company
- 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 body processes the study drug and how the study drug affects the body. Each enrolled participant will receive injections of LY3437943 or placebo given just under the skin. For each participant, the study will last up to 5 months, inclusive of screening and will include 16 visits to the study center.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- 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
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3437943 LY3437943 LY3437943 administered subcutaneously (SC) Placebo Placebo Placebo administered SC
- Primary Outcome Measures
Name Time Method Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Baseline through Day 106 A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
- Secondary Outcome Measures
Name Time Method PK: Area Under the Concentration Versus Time Curve (AUC) of LY3437943 Predose on Day 1 through Day 81 PK: AUC of LY3437943
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943 Predose on Day 1 through Day 81 PK: Cmax of LY3437943
Change from Baseline in Fasting Glucose Baseline through Day 78 Change from Baseline in Fasting Glucose
Change from Baseline in Mean Daily Plasma Glucose (PG) Baseline through Day 80 Change from baseline in mean daily PG from 6-point PG profile
Change from Baseline in Glycated Hemoglobin (HbA1c) Baseline through Day 78 Change from Baseline in HbA1c
Change from Baseline in Body Weight Baseline through Day 78 Change from Baseline in Body Weight
Trial Locations
- Locations (4)
Clinical Research Hospital Tokyo
🇯🇵Shinjuku-ku, Tokyo, Japan
Yokohama Minoru Clinic
🇯🇵Yokohama, Japan
Medical Corporation Heishinkai OCROM Clinic
🇯🇵Suita-shi, Osaka, Japan
P-one clinic
🇯🇵Hachioji, Tokyo, Japan