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NCT Number: NCT07090785

A Study of LY4088044 in Healthy Participants

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.

Recruiting

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New Zealand Clinical Research Christchurch, Christchurch, New Zealand

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY4088044

Drug

Administered IV

Placebo

Drug

Administered IV

Primary outcomes

  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: Baseline up to Approximately Day 190

    A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4088044

    Time frame: Baseline up to Approximately Day 190

    PK: Cmax of LY4088044

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY4088044

    Time frame: Baseline up to Approximately Day 190

    PK: AUC of LY4088044

  3. Pharmacodynamics (PD): Protein Levels in Skin Samples

    Time frame: Baseline up to Approximately Day 190

    PD: Percent Decrease in Protein Levels

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 29, 2025
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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