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A Study of LY4088044 in Healthy Participants
A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4088044 in Healthy Participants.
Who can join
Ages 18 to 65 · All sexes · Healthy volunteers welcome
Full 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 (BMI) within the range 18.5 to 30 kilogram per square meter (kg/m²) Exclusion Criteria: * Are individuals assigned female at birth (AFAB) who are pregnant and/or lactating * Regularly use known drugs of abuse or show positive findings on urinary drug screening that are not consistent with their medication history * Participants with hemoglobin outside of the local laboratory normal range for age and gender, or evidence of iron deficiency, or hemoglobinopathy * Participants with estimated glomerular filtration rate (GFR) less than 90 milliliter per minute per 1.73 square meter (mL/min/1.73 m²) * Have a 12-lead electrocardiogram (ECG) abnormality * 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 21 units per week (males less than or equal to 65 years old) and 14 units per week (females and males over 65-year-old, if applicable) and are unwilling to abide by the restrictions
About the study
The purpose of this study is to evaluate how well LY4088044 is tolerated and what side effects may occur in healthy participants. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4088044 gets into the bloodstream and how long it takes the body to eliminate it.
The study will last up to approximately 92 weeks for Parts A, B, and C, excluding screening.
What is being tested
- LY4088044 (drug)
- LY4088044 (drug)
- Placebo (drug)
- Placebo (drug)
Sponsor: Eli Lilly and Company · Participants: 104 · Started: Jul 24, 2025
Contact the study team
- Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · Phone: 1-317-615-4559
Official record on ClinicalTrials.gov — NCT07090785
Locations in the U.S.
| California | Collaborative Neuroscience Network - CNS, Los Alamitos |
| Texas | ICON Early Phase Services, San Antonio |
| Utah | ICON, Salt Lake City |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.