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Clinical Trials in the USA / NCT07090785
Recruiting Phase 1

A Study of LY4088044 in Healthy Participants

NCT07090785 · tracked via the Priya Life Science USA tracker
Sponsor
Eli Lilly and Company
Phase
Phase 1
Started
2025-07-24
Last updated
2026-10-07

Condition(s) studied

Healthy

Investigational drug(s) / intervention(s)

LY4088044LY4088044PlaceboPlacebo

LY4088044: Administered IV

LY4088044: Administered SC

Placebo: Administered IV

Placebo: Administered SC

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — Baseline up to Approximately Day 190
    A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module

Trial sites (6)

FacilityCityRegionStatus
Collaborative Neuroscience Network - CNS Los Alamitos California Active Not Recruiting
ICON Lenexa Kansas Suspended
ICON Early Phase Services San Antonio Texas Recruiting
ICON Salt Lake City Utah Recruiting
New Zealand Clinical Research Christchurch Christchurch New Zealand Not Yet Recruiting
Lilly Centre for Clinical Pharmacology Singapore Singapore Recruiting

More Eli Lilly and Company trials in the USA

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A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2) Active, not recruiting
A Study of Sofe-M in Participants With Selected Advanced Solid Tumors Recruiting
A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD) Recruiting

Other trials for the same condition

A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants Recruiting
Evaluating the Safety, Tolerability, and Pharmacokinetics of DF-003 in Healthy Subjects Active, not recruiting
Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments, Using Multiomics Recruiting
A Study of LY4355756 in Healthy Participants Recruiting
Safety and Immunogenicity of V540B in Healthy Adults (V540B-002). Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07090785 on ClinicalTrials.gov ↗ ← All trials in the USA