Healthy, Type 2 Diabetes Mellitus (T2D)
Conditions
Keywords
Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Diabetes Mellitus, Diabetes Mellitus, Type 2
Brief summary
The purpose of this study is to evaluate how well LY3549492 is tolerated and what side effects may occur in Japanese participants with Type 2 Diabetes Mellitus (T2D) and healthy Japanese participants. The study drug will be administered orally. Blood tests will be performed to check how much LY3549492 gets into the bloodstream and how long it takes the body to eliminate it. The study will last up to approximately 19 weeks for both Part A (Cohorts 1-3) for multiple-ascending doses (MAD), and Part B (Cohorts 4-5) multiple-ascending doses (MAD), for a total of approximately 25 weeks, including screening.
Interventions
DRUGLY3549492
Administered orally
DRUGPlacebo
Administered orally
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
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Part A: * Participants with T2DM for at least 6 months * With an HbA1c value: * equal to or greater than 7.0% and equal to or less than 10.0% at screening for participants treated with diet and exercise alone, OR * equal to or greater than 6.5% and equal to or less than 9.0% for participants prior to washout of antidiabetic medications * Have had a stable weight for the 3 months prior to screening. Stable weight is defined as less than 5% body weight change Part B: * Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. Laboratory tests may be repeated if there is a documented technical error, or once at the discretion of the investigator for any out-of-range results
Exclusion criteria
* Have a known clinically significant gastric emptying abnormality * Have a 12-lead electrocardiogram (ECG) abnormality * Have an abnormal blood pressure or pulse rate * Have a significant history within the past 6 months or current evidence of comorbidities capable of altering the absorption, metabolism, or elimination of drug. Or constituting a risk when taking the study drug * Have a history of chronic medical conditions involving the heart, liver, or kidneys
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Day 1 Through Day 127 | A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3549492 | Day 1 Through Day 127 | PK: AUC of LY3549492 |
| PK: Maximum Concentration (Cmax) of LY3549492 | Day 1 Through Day 127 | PK: Cmax of LY3549492 |
| Pharmacodynamic (PD): Part A: Change from Baseline in Hemoglobin A1c (HbA1c) | Day 1 Through Day 127 | PD: Change from Baseline in Hemoglobin A1c (HbA1c) |
| PD: Change from Baseline in Body Weight | Day 1 Through Day 127 | PD: Change from Baseline in Body Weight |
Countries
Japan
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed