Diabetes Mellitus, Type 2
Conditions
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.
Interventions
DRUGLY3437943
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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 3× upper limit of normal (ULN).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3437943 | Predose on Day 1 through Day 81 | PK: AUC of LY3437943 |
| 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 |
| 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 Body Weight | Baseline through Day 78 | Change from Baseline in Body Weight |
| Change from Baseline in Glycated Hemoglobin (HbA1c) | Baseline through Day 78 | Change from Baseline in HbA1c |
Countries
Japan
Outcome results
None listed