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Clinical trial Recruiting at 3 sites Phase 1 Interventional Ages 18 to 65

LY4088044 in healthy volunteers

Official title: 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.

Run by Eli Lilly and Company · NCT07090785 · Data updated 2026-11-12

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

PhasePhase 1
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment104 (estimated)
SponsorEli Lilly and Company
Industry-sponsored
Locations6 sites (Los Alamitos, California and 5 other locations)
StatusRecruiting
StartedJuly 24, 2025
Main results expectedJuly 2027
Study endsJuly 2027
Registry record updatedOctober 7, 2026
Trial IDNCT07090785 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • ICON Early Phase Services
    San Antonio, Texas, United States     Recruiting
  • Icon
    Salt Lake City, Utah, United States     Recruiting
  • Lilly Centre for Clinical Pharmacology
    Singapore, Singapore     Recruiting
  • Collaborative Neuroscience Network - CNS
    Los Alamitos, California, United States     Active not recruiting
  • Icon
    Lenexa, Kansas, United States     Suspended
  • New Zealand Clinical Research Christchurch
    Christchurch, New Zealand     Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.