A Study of LY4515100 in Healthy Participants

NCT ID: NCT07339722

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-07-31

Brief Summary

The main purpose of this study is to assess the safety and tolerability of LY4515100 when given orally to healthy participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last up to 30 days and will include six overnight stays.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

LY4515100 of Part A (SAD)

Single-ascending doses of LY4515100 will be given orally

Group Type: EXPERIMENTAL

LY4515100 via SAD

Intervention Type: DRUG

given orally

LY4515100 of Part B (MAD)

Multiple-ascending doses of LY4515100 will be given orally

Group Type: EXPERIMENTAL

LY4515100 via MAD

Intervention Type: DRUG

given orally

Placebo Part A

Placebo will be given orally

Group Type: PLACEBO_COMPARATOR

LY4515100 via SAD

Intervention Type: DRUG

given orally

Placebo Part B

Placebo will be given orally

Group Type: PLACEBO_COMPARATOR

LY4515100 via MAD

Intervention Type: DRUG

given orally

Interventions

LY4515100 via SAD

given orally

Intervention Type: DRUG

LY4515100 via MAD

given orally

Intervention Type: DRUG

Eligibility Criteria

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 within the range of 18.5 to 32.0 kilograms per square meter (kg/m^2) (inclusive).
• Individuals of childbearing potential (IOCBP) are excluded from this trial.
• Individuals not of childbearing potential (INOCBP) may participate in this trial.

Exclusion Criteria

• Have donated 500 milliliters (mL) of blood within 30 days prior to dosing.
• Have participated within the last 30 days in a clinical study involving an investigational medicinal product. If the previous investigational product (IP) has a long half-life, 5 half-lives or 30 days (whichever is longer) should have passed.
• Participants with hemoglobin outside of the local laboratory normal reference range for age and sex, which is judged to be clinically significant by the investigator.
• Participants with an estimated glomerular filtration rate <90 mL/min/1.73 m2.
• Have a 12-lead Electrocardiogram (ECG) abnormality that, in the opinion of the investigator,
• increases the risks associated with participating in the study
• may confound ECG data analysis
• Have used or intend to use over-the-counter or prescription medication including dietary or herbal medications within 7 days, or 14 days if the medication is a potential enzyme inducer, or 5 half-lives (whichever is longer), prior to dosing.
• 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 14 units per week (males 65 years of age or younger) and 7 units per week (females and males greater than 65 years of age, if applicable)
• Show evidence of
• Human immunodeficiency virus (HIV) infection and/or positive human HIV antigen and/or antibodies
• hepatitis C and/or positive hepatitis C antibody
• hepatitis B and/or positive hepatitis B surface antigen.
• Have liver disease.
• Any clinical condition or procedure (for example, gastrointestinal obstruction, gastric bypass, or cholecystectomy) that may affect the absorption, distribution, or excretion of the study drug and confound pharmacokinetics (PK) assessment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Contact Lilly at 1-877-CTLILLY (1-877-285-4559) or

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Fortrea Clinical Research Unit

Dallas, Texas, United States

Countries

United States

Central Contacts

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Role: CONTACT

clinical_inquiry_hub@lilly.com

1-317-615-4559

Facility Contacts

Role: primary

866-429-3700

Other Identifiers

J6V-MC-OIAB

Identifier Type: OTHER

Identifier Source: secondary_id

27789

Identifier Type: -

Identifier Source: org_study_id