Healthy
Conditions
Brief summary
The purpose of this study is to evaluate the safety of LY3305677 and any side effects that might be associated with it. This study will also look at how much LY3305677 gets into the blood stream, how long it takes the body to remove it. This study involves a single dose of LY3305677 administered by subcutaneous injection (SC). Participation in this study is expected to last up to 16 weeks.
Interventions
DRUGLY3305677
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Overtly healthy as determined by medical history and physical examination * Male participants: will agree to use a reliable method of birth control and will not donate sperm during the study and for at least 3 months following the last dose of the investigational product * Female participants: women not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause * First generation Japanese participants or non-Japanese participants * Have a body weight of more than 50 kilograms (kg)
Exclusion criteria
* Have participated within the last 3 months in a clinical trial involving an investigational product * Have known allergies to glucagon-like peptide-1 (GLP-1) analogs, or any components of the formulation, or history of significant atopy * Have an abnormality in the 12-lead electrocardiogram (ECG) at screening and/or Day -1 * Have undergone any form of bariatric surgery * Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis * Have a history of acute or chronic pancreatitis or elevation in serum lipase and/or amylase * Show evidence of human immunodeficiency virus (HIV) or Hepatitis B or C * Have used or intend to use medications that promote weight loss * Have donated blood of more than 500 milliliter (mL) within the last month * Currently smoke more than 10 cigarettes per day
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) considered by the Investigator to be Related to Study Drug Administration | Baseline to Study Completion (approximately 16 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3305677 | Day 1 Pre-dose through Day 85 |
| Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3305677 | Day 1 Pre-dose through Day 85 |
Countries
United Kingdom
Outcome results
None listed