A Study of LY4088044 in Healthy Participants

Lilly

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: LY4088044; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07090785

J5S-MC-CEAA (Other Identifier)

27275

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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104 participants in 6 patient groups, including a placebo group

LY4088044 (Part A)

Experimental group

Description:

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

Treatment:

Drug: LY4088044

Drug: LY4088044

Placebo (Part A)

Placebo Comparator group

Description:

Administered IV

Treatment:

Drug: Placebo

Drug: Placebo

LY4088044 (Part B)

Experimental group

Description:

SAD of LY4088044 administered subcutaneously (SC)

Treatment:

Drug: LY4088044

Drug: LY4088044

Placebo (Part B)

Placebo Comparator group

Description:

Administered SC

Treatment:

Drug: Placebo

Drug: Placebo

LY4088044 (Part C)

Experimental group

Description:

Multiple-ascending doses (MAD) of LY4088044 administered IV

Treatment:

Drug: LY4088044

Drug: LY4088044

Placebo (Part C)

Placebo Comparator group

Description:

Administered IV

Treatment:

Drug: Placebo

Drug: Placebo