Healthy Type 2 Diabetes Mellitus (T2D)
Conditions
Interventions
DRUG: LY3549492
Administered orally
DRUG: Placebo
Administered orally
(Study Arms)
Experimental: LY3549492 Part A
LY3549492 administered orally
Interventions:
Drug: LY3549492
Experimental
Sponsors
Wakayama Naohiko
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 |
|---|---|
| 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 [ Time Frame: Day 1 Through Day 127 A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module | — |
Contacts
Public ContactTrial Guide Call Center
Eli Lilly Japan K.K.
Outcome results
None listed