RecruitingPhase 1NCT07339722

A Study of LY4515100 in Healthy Participants

A Phase 1, Randomized, Investigator- and Participant-Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Characterize the Safety, Tolerability, and Pharmacokinetics of LY4515100 in Healthy Participants

Sponsor

Eli Lilly and Company

Enrollment

40 participants

Start Date

Jan 15, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy

Summary

The main purpose of this study is to assess the safety and tolerability of LY4515100 when given orally to healthy participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last up to 30 days and will include six overnight stays.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring.
Have a body mass index within the range of 18.5 to 32.0 kilograms per square meter (kg/m\^2) (inclusive).
Individuals of childbearing potential (IOCBP) are excluded from this trial.
Individuals not of childbearing potential (INOCBP) may participate in this trial.

Exclusion Criteria16

Have donated 500 milliliters (mL) of blood within 30 days prior to dosing.
Have participated within the last 30 days in a clinical study involving an investigational medicinal product. If the previous investigational product (IP) has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed.
Participants with hemoglobin outside of the local laboratory normal reference range for age and sex, which is judged to be clinically significant by the investigator.
Participants with an estimated glomerular filtration rate <90 mL/min/1.73 m2.
Have a 12-lead Electrocardiogram (ECG) abnormality that, in the opinion of the investigator,
increases the risks associated with participating in the study
may confound ECG data analysis
Have used or intend to use over-the-counter or prescription medication including dietary or herbal medications within 7 days, or 14 days if the medication is a potential enzyme inducer, or 5 half-lives (whichever is longer), prior to dosing.
Smoke more than 10 cigarettes per day or the equivalent, including electronic cigarettes, and are unable to abide by investigative site smoking restrictions.
Have an average weekly alcohol intake that exceeds 14 units per week (males 65 years of age or younger) and 7 units per week (females and males greater than 65 years of age, if applicable)
Show evidence of
Human immunodeficiency virus (HIV) infection and/or positive human HIV antigen and/or antibodies
hepatitis C and/or positive hepatitis C antibody
hepatitis B and/or positive hepatitis B surface antigen.
Have liver disease.
Any clinical condition or procedure (for example, gastrointestinal obstruction, gastric bypass, or cholecystectomy) that may affect the absorption, distribution, or excretion of the study drug and confound pharmacokinetics (PK) assessment.