A Study of LY4088044 in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-24

Study Completion Date

2027-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Sponsor is blinded

Study Groups

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LY4088044 (Part A)

Single-ascending dose (SAD) of LY4088044 administered intravenously (IV)

Group Type EXPERIMENTAL

LY4088044

Intervention Type DRUG

Administered IV

Placebo (Part A)

Administered IV

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered IV

LY4088044 (Part B)

SAD of LY4088044 administered subcutaneously (SC)

Group Type EXPERIMENTAL

LY4088044

Intervention Type DRUG

Administered SC

Placebo (Part B)

Administered SC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

LY4088044 (Part C)

Multiple-ascending doses (MAD) of LY4088044 administered IV

Group Type EXPERIMENTAL

LY4088044

Intervention Type DRUG

Administered IV

Placebo (Part C)

Administered IV

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered IV

Interventions

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LY4088044

Administered IV

Intervention Type DRUG

LY4088044

Administered SC

Intervention Type DRUG

Placebo

Administered IV

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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