Recruiting
Phase 1

LY4088044

Sponsor:

Eli Lilly and Company

Code:

NCT07090785

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

LY4088044

LY4088044

Placebo

Placebo

Study Details

Brief 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.

Conditions

Healthy

Study ID

NCT07090785

Start date

Jul 24, 2025

Status verified date

Oct, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

104 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: LY4088044 (Part A)

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

placebo comparator: Placebo (Part A)

Administered IV

experimental: LY4088044 (Part B)

SAD of LY4088044 administered subcutaneously (SC)

placebo comparator: Placebo (Part B)

Administered SC

experimental: LY4088044 (Part C)

Multiple-ascending doses (MAD) of LY4088044 administered IV

placebo comparator: Placebo (Part C)

Administered IV

Interventions

LY4088044

Administered IV

LY4088044

Administered SC

Placebo

Administered IV

Placebo

Administered SC

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

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

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

ICON Early Phase Services

Recruiting

San Antonio, Texas, United States, 78232

Contacts

210-283-4156

Principal Investigator:

Chinonye Ogbonnaya-Odor

ICON

Recruiting

Salt Lake City, Utah, United States, 84124

Contacts

801-269-8200

Principal Investigator:

Ahad Sabet

More Information

Sponsor

Eli Lilly and Company

Last update posted

Oct 7, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-18. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-10-07. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.