A Study of LY4302814 in Healthy Participants

A Phase 1, Randomized, Placebo-Controlled, Investigator and Participant Blinded, Single Ascending Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4302814 in Healthy Participants

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: Placebo; Drug: LY4302814; Drug: LY4302814

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: LillyTrials@Lilly.com
• Study Contact Backup: Name: Physicians interested in becoming principal investigators please contact; Email: clinical_inquiry_hub@lilly.com

Study Locations

• Singapore
  • Singapore, Singapore, 138623
    • Lilly Centre for Clinical Pharmacology
    • Principal Investigator: Noel Varghese
    • Contact: Phone Number: +65 6413 9832
• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Fortrea Clinical Research Unit
      • Contact: Phone Number: 866-429-3700
      • Principal Investigator: Chiamaka Iheme

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY4302814 IV; LY4302814 administered intravenously (IV)	Drug: LY4302814; Administered SC; Drug: LY4302814; Administered IV
Placebo Comparator: Placebo IV; Placebo administered IV	Drug: Placebo; Administered SC; Drug: Placebo; Administered IV
Experimental: LY4302814 SC; LY4302814 administered subcutaneously (SC)	Drug: LY4302814; Administered SC; Drug: LY4302814; Administered IV
Placebo Comparator: Placebo SC; Placebo administered SC	Drug: Placebo; Administered SC; Drug: Placebo; Administered IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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 record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 27809; J7A-MC-NGAA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No