Recruiting
Phase 1

LY4302814

Sponsor:

Eli Lilly and Company

Code:

NCT07566338

Conditions

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

LY4302814

LY4302814

Placebo

Placebo

Study Details

Brief summary:

The main purpose of this study is to assess how well LY4302814 is tolerated and what side effects may occur in healthy participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant, the study will last about 6 months and will include at least one overnight stay in the clinical research unit (CRU) lasting up to approximately 9 days.

Conditions

Healthy

Study ID

NCT07566338

Start date

May 6, 2026

Status verified date

Jun, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Are overtly healthy as determined by medical evaluation.
  • Have clinical laboratory test results within the normal range for the population or investigative site or with abnormalities deemed not clinically significant by the investigator.
  • Have a body weight of 45 kilograms (kg) or greater and body mass index within 18 to 32 kilogram per square meter (kg/m ²), inclusive.
  • Are individuals assigned female at birth (AFAB) and not of childbearing potential, and individuals assigned male at birth (AMAB). Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Adult participants in Singapore:

  • Are 21 years of age or older.

Exclusion Criteria:

  • Evidence or history of clinically significant conditions.
  • Have a 12-lead electrocardiogram (ECG) abnormality, that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis.
  • Show evidence of hepatitis B virus (HBV) infection with a positive hepatitis B surface antigen (HBsAg) or anti-hepatitis B core (HBc).
  • Show evidence of hepatitis C virus (HCV) infection, with positive anti-HCV.
  • Have human immunodeficiency virus (HIV) infection or positive HIV-1 and HIV-2 antibodies.
  • Have used or intend to use herbal, vitamin supplements, over-the-counter or prescription medication, within 14 days or 5 half-lives (whichever is longer) prior to dosing and during the study, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
  • Smoke more than 5 cigarettes a day, or the equivalent in nicotine-containing products, and/or are unable to abide by clinical research unit (CRU) smoking restrictions.
  • Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: LY4302814 IV

LY4302814 administered intravenously (IV)

placebo comparator: Placebo IV

Placebo administered IV

experimental: LY4302814 SC

LY4302814 administered subcutaneously (SC)

placebo comparator: Placebo SC

Placebo administered SC

Interventions

LY4302814

Administered SC

LY4302814

Administered IV

Placebo

Administered SC

Placebo

Administered IV

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: Day 1 through Day 197 ]

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

Fortrea Clinical Research Unit

Recruiting

Daytona Beach, Florida, United States, 32117

Contacts

866-429-3700

Principal Investigator:

Chiamaka Iheme

More Information

Sponsor

Eli Lilly and Company

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-06-16.