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A Study of LY4088044 in Healthy Participants

Description

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.

Conditions

Healthy
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Healthy

Study Overview

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Study Details

Study overview

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.

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.

A Study of LY4088044 in Healthy Participants

Condition
Healthy
Intervention / Treatment

-

Contacts and Locations

Los Alamitos

Collaborative Neuroscience Network - CNS, Los Alamitos, California, United States, 90720

Salt Lake City

ICON, Salt Lake City, Utah, United States, 84124

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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 less than 12 gram per deciliter (g/dl) for females or less than 14 milligram per deciliter (mg/dl) for males, 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2027-05