Healthy
Conditions
Brief summary
The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in healthy participants. Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it. This study will last approximately 8 weeks including screening period.
Interventions
DRUGLY3532226
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
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Overtly healthy males or females not of childbearing potential. * Body mass index (BMI) within the range of 18.5 to 40 kilograms per meter squared (kg/m²), inclusive
Exclusion criteria
* Have a significant history of or current CV (e.g., myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk while taking the study intervention; or of interfering with the interpretation of data * Have a history of malignancy within 5 years prior to screening * Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis * Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2X the upper limit of normal (ULN) or total bilirubin level (TBL) \>1.5X ULN * Have serum triglyceride level ≥5 mmol/L (442.5 mg/dL) * Have undergone any form of bariatric surgery * Have received systemic or inhaled glucocorticoid therapy (excluding topical, intraarticular, and intraocular preparations); for more than 14 consecutive days within 4 weeks before screening
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 up to Week 8 | 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: Time to Maximum Concentration (Tmax) of LY3532226 | Day 1 through Day 43 | PK: Tmax of LY3532226 |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3532226 | Day 1 through Day 43 | PK: Cmax of LY3532226 |
| PK: Area Under the Concentration Versus Time Curve (AUC) of LY3532226 | Day 1 through Day 43 | PK: AUC of LY3532226 |
Countries
Singapore
Outcome results
None listed