Healthy
Conditions
Brief summary
The purposes of this study are to determine: * The safety of LY3305677 and any side effects that might be associated with it. * How much LY3305677 gets into the bloodstream and how long it takes the body to remove it in healthy participants, including those of Japanese origin. * The effect LY3305677 has on the body, particularly the effect on blood glucose levels. This study will last approximately 17 weeks not including screening. Screening is required within 4 weeks prior to start of the study. This study is for research purposes only and is not intended to treat any medical conditions.
Interventions
DRUGLY3305677
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 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy males or females, as determined by medical history and physical examination * Women not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause * Are first-generation Japanese or non-Japanese. First-generation Japanese is defined as the participant, the participant's biological parents, and all of the participant's grandparents are of exclusive Japanese descent and have been born in Japan * Have a body weight of more than 54 kilograms (kg)
Exclusion criteria
* Currently enrolled in a clinical study or have participated in a study within the past 3 months * Have an abnormality in the 12-lead electrocardiogram (ECG) at screening * Have history of pancreatitis * Have known or ongoing psychiatric disorders * Have undergone bariatric surgery or have used any drugs for weight loss * Have a history of alcoholism * Currently smoke more than 10 cigarettes a day
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 115 days | 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 |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3305677 | Days 1 and 29: Predose through 168 hours post dose | PK: Cmax of LY3305677 |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3305677 | Days 1 and 29: Predose through 168 hours post dose | PK: AUC of LY3305677 |
Countries
United Kingdom
Outcome results
None listed