A Study of LY4302814 in Healthy Participants

NCT07566338 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27809J7A-MC-NGAA
• Study Type: interventional
• Target: 150
• Locations: 2 countries
• Sites: 2

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

Outcome Measures

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

  Day 1 through Day 197

Secondary Outcomes (2)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4302814

  Day 1 through Day 197

• PK: Maximum Concentration (Cmax) of LY4302814

  Day 1 through Day 197

Study Arms (4)

LY4302814 IV

EXPERIMENTAL

LY4302814 administered intravenously (IV)

Drug: LY4302814

Placebo IV

PLACEBO COMPARATOR

Placebo administered IV

Drug: Placebo

LY4302814 SC

EXPERIMENTAL

LY4302814 administered subcutaneously (SC)

Drug: LY4302814

Placebo SC

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

Interventions

LY4302814 DRUG

Administered SC

LY4302814 SC

Placebo DRUG

Administered SC

Placebo SC

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

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

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 5, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); SG (1)