LY4088044 in healthy volunteers
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.
This trial will test how LY4088044 is tolerated and cleared from the body when given under the skin or into a vein in healthy adults.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 6 sites (Los Alamitos, California and 5 other locations) |
| Trial ID | NCT07090785 on ClinicalTrials.gov |
What this trial studies
This Phase 1 trial gives LY4088044 or placebo to overtly healthy adults to characterize safety, tolerability, and how the drug moves through and is eliminated from the body. The drug is administered either subcutaneously (SC) or intravenously (IV), with blood sampling for pharmacokinetics and routine safety labs and cardiac monitoring. The study includes multiple parts (A, B, and C) and may last up to about 92 weeks excluding screening, with safety and lab-based eligibility criteria applied at enrollment. Participants must meet BMI and laboratory limits and will be excluded for pregnancy/lactation, significant kidney impairment, ECG abnormalities, certain hemoglobin issues, heavy smoking, or illicit drug use.
Who should consider this trial
Good fit: Ideal candidates are overtly healthy adults with BMI between 18.5 and 30 kg/m² who have normal labs, normal ECG, adequate kidney function, are not pregnant or breastfeeding, and can comply with study visits.
Not a fit: People with active medical conditions, pregnancy or lactation, low hemoglobin or evidence of iron disorders, impaired kidney function (eGFR <90 mL/min/1.73 m²), ECG abnormalities, heavy smokers, or recent illicit drug use are unlikely to be eligible or benefit from participation.
Why it matters
Potential benefit: If successful, the results could show LY4088044 is safe and has predictable blood levels, enabling future patient studies for conditions the drug may target.
How similar studies have performed: This is a standard first-in-human PK/safety approach commonly used for experimental drugs and has been successful in establishing dosing and safety for many therapies, though LY4088044 itself is early-stage.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Los Alamitos, California and 5 other locations
- Collaborative Neuroscience Network - CNS — Los Alamitos, California, United States (Not_yet_recruiting)
- Icon — Lenexa, Kansas, United States (Not_yet_recruiting)
- ICON Early Phase Services — San Antonio, Texas, United States (Recruiting)
- Icon — Salt Lake City, Utah, United States (Recruiting)
- New Zealand Clinical Research Christchurch — Christchurch, New Zealand (Not_yet_recruiting)
- Lilly Centre for Clinical Pharmacology — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.