Healthy
Conditions
Brief summary
The main purpose of this study is to evaluate the safety and tolerability of LY3537031 in healthy participants. The blood tests will be performed to check how much LY3537031 gets into the bloodstream, how long the body takes to eliminate it and how body handles LY3537031. Each participant will receive a single dose of LY3537031 or placebo. The study will last up to approximately 71 days for each participant, including screening.
Interventions
DRUGLY3537031
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 male or female not of childbearing potential * Have a body mass index (BMI) between 19 and 35 kilograms per square meter (kg/m²) and a body weight ≥ 54 kilograms (kg) * Have blood pressure, pulse rate, blood and urine laboratory test results that are acceptable for the study * Have veins suitable for blood sampling
Exclusion criteria
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study * Have a diagnosis or history of cancer or malignant disease within 5 years * Have been treated with prescription and over-the-counter medications that promote weight loss within 3 months prior to screening * Show clinical evidence of syphilis, HIV, hepatitis C, or hepatitis B, and/or test positive * Have undergone any form of bariatric surgery * Have previously completed or withdrawn from this study * Are currently participating in or completed a clinical trial within the last 3 months * Regularly use known drugs of abuse or with positive drug results * Smoke \>10 cigarettes per day or the equivalent, or are unable or unwilling to refrain from nicotine during CRU admission
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 final follow-up at approximately Day 43 | 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): Area Under the Concentration Versus Time Curve (AUC) of LY3537031 | Baseline through final follow-up at approximately Day 43 | PK: AUC of LY3537031 |
| PK: Maximum Concentration (Cmax) of LY3537031 | Baseline through final follow-up at approximately Day 43 | PK: Cmax of LY3537031 |
Countries
Japan
Outcome results
None listed