LY4515100 in healthy adults

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

This study will test whether taking LY4515100 by mouth is safe and well tolerated in healthy adults and will measure how the body processes the drug.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Eli Lilly and Company (Industry-sponsored)
• Locations: 1 site (Dallas, Texas)
• Trial ID: NCT07339722 on ClinicalTrials.gov

What this trial studies

This phase 1 trial uses single-ascending-dose (SAD) and multiple-ascending-dose (MAD) cohorts to characterize safety, tolerability, and pharmacokinetics of oral LY4515100 in healthy adults. Participants will be dosed and monitored at a clinical research unit with blood tests, vital signs, and cardiac monitoring to track how the drug is absorbed, distributed, metabolized, and eliminated. The trial lasts up to 30 days and includes six overnight stays for intensive monitoring. Individuals of childbearing potential are excluded and enrollment requires a BMI of 18.5–32 kg/m2 and normal screening labs.

Who should consider this trial

Good fit: Ideal participants are healthy adults who are not of childbearing potential, have a BMI between 18.5 and 32 kg/m2, pass screening labs and cardiac checks, and can attend the Fortrea unit in Dallas for six overnight stays within a 30-day period.

Not a fit: People with active medical conditions, those who are of childbearing potential or pregnant, recent blood donors, or those with abnormal screening labs are unlikely to receive any health benefit from participating.

Why it matters

Potential benefit: If results are favorable, the trial could define safe dose ranges and enable later studies that test whether LY4515100 helps people with the target condition.

How similar studies have performed: Single- and multiple-ascending-dose phase 1 designs are a standard step that has supported development of many drugs, but LY4515100 itself has not yet been shown to be effective in patients.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Dallas, Texas

• Fortrea Clinical Research Unit — Dallas, Texas, United States (Recruiting)

Study contacts

• Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Conditions Healthy