Healthy
Conditions
Brief summary
The main purpose of this study is to find out how much LY3537031 gets into the blood stream and how long it takes the body to get rid of it when it is injected just under the skin in different parts of the body, and when it is injected into a vein, in healthy participants. This study will also look at the safety and tolerability of LY3537031.
Interventions
DRUGLY3537031
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Are overtly healthy as determined by medical evaluation including medical history and physical examination. * Have a body weight of at least 45 kg. * Have a Body Mass Index (BMI) within the range of 18.5 and 35.0 kg/m², inclusive * Do not have skin aberrations that would preclude administration of the study drug at the planned injection sites.
Exclusion criteria
* Have significant history or current cardiovascular, respiratory, hepatic, renal, Gastrointestinal (GI), endocrine, hematological, dermatological, or neurological disorders that, in the opinion of the investigator, are capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data. * Have a history of atopy; that is, severe or multiple allergic manifestations, or clinically significant multiple or severe drug allergies, or hyperesthesia, or severe post treatment hypersensitivity reactions, or have known allergies to LY3537031, Glucagon-Like Peptide-1 (GLP-1) analogs, or related compounds. * Have undergone any form of bariatric surgery. * Have a diagnosis or history of malignant disease within 5 years before screening, with the following (some exceptions are allowed) * Have a history of or current acute or chronic pancreatitis, or elevation in serum lipase or amylase or both greater than 1.5× Upper Limit of Normal (ULN). * Have a history of chronic liver disease, acute or chronic hepatitis, including a history of autoimmune hepatitis, or any evidence for hepatic impairment. * Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome Type 2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3537031 | Day 1 Predose up to Day 64 | PK: AUC of LY3537031 |
| Pharmacokinetics (PK): Maximum Serum Observed Drug Concentration (Cmax) of LY3537031 | Day 1 Predose up to Day 64 | PK: Cmax of LY3537031 |
Countries
Singapore
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed