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NCT07090785PHASE1RecruitingAccepts Healthy Volunteers

A Study of LY4088044 in Healthy Participants

Eli Lilly and Company

Start Date

7/24/2025

Completion Date

7/1/2027

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 Criteria

Age Range: 18 years to 65 years

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

Interventions

DRUG

LY4088044

DRUG

LY4088044

DRUG

Placebo

DRUG

Placebo

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Conditions

Healthy

Locations

Collaborative Neuroscience Network - CNS

Los Alamitos, California 90720

United States

ICON

Lenexa, Kansas 66219

United States

ICON Early Phase Services

San Antonio, Texas 78232

United States

ICON

Salt Lake City, Utah 84124

United States

New Zealand Clinical Research Christchurch

Christchurch, 8011

New Zealand

Lilly Centre for Clinical Pharmacology

Singapore, 138623

Singapore