Type 2 Diabetes
Conditions
Brief summary
The main purpose of this study is to investigate LY3549492 in Chinese participants with type 2 diabetes. Participation in the study will last about 18 weeks.
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Are native Chinese * Have type 2 diabetes for at least 6 months * Have been treated with diet and exercise, with or without a stable dose of metformin for at least 3 months * Have hemoglobin A1c (HbA1c) of at least 7% and no greater than 10% * Have a body mass index (BMI) of at least 20 milligrams per square meter (kg/m2) and no greater than 40 kg/m2 * Have had a stable body weight for the 3 months prior to screening * Women must not be of childbearing potential
Exclusion criteria
* Have type 1 diabetes or have had an episode of ketoacidosis or hyperosmolar state requiring hospitalization * Have had an episode of severe hypoglycemia within 6 months or have a history of hypoglycemia unawareness * Have a clinically significant gastric emptying abnormality * Have or have a history of pancreatitis * Have signs and symptoms of liver disease, with the exception of non-alcoholic fatty liver disease * Have a personal or family history of multiple endocrine neoplasia syndrome type 2 or medullary thyroid carcinoma * Have an uncontrolled endocrine abnormality * Have an abnormal blood pressure or pulse rate * Have a 12-lead electrocardiogram (ECG) abnormality * Have a significant history within the past 6 months or current evidence of comorbidities capable of altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study intervention, or of interfering with the interpretation of data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration | Baseline through Week 14 | A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3549492 | Predose through Week 13 |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3549492 | Predose through Week 13 |
Countries
China
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