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NCT Number: NCT07339722

A Study of LY4515100 in Healthy Participants

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.

Recruiting

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

Location status: Recruiting

Location contact

Gene Voskuhl

PRINCIPAL_INVESTIGATOR

CONTACT

866-429-3700

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY4515100 via SAD

Drug

given orally

LY4515100 via MAD

Drug

given orally

Primary outcomes

  1. Number of participants with one or more serious adverse event(s) (SAEs) of LY4515100

    Time frame: Day 1 up to Day 30

    SAEs of LY4515100

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY4515100

    Time frame: Day 1 through Day 11

    PK: AUC of LY4515100

  2. PK: Maximum Observed Drug Concentration (Cmax) of LY4515100

    Time frame: Time Frame: Day 1 through Day 11

    PK: Cmax of LY4515100

  3. PK: Time of maximum observed drug concentration (tmax) of LY4515100

    Time frame: Day 1 through Day 11

    PK: tmax of LY4515100

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1, Randomized, Investigator- and Participant-Blinded, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Characterize the Safety, Tolerability, and Pharmacokinetics of LY4515100 in Healthy Participants

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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