NCT07339722

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
2mo left

Started Jan 2026

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Jan 2026Jul 2026

First Submitted

Initial submission to the registry

January 6, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

January 6, 2026

Last Update Submit

February 27, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

    SAEs of LY4515100

    Day 1 up to Day 30

Secondary Outcomes (3)

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

    Day 1 through Day 11

  • PK: Maximum Observed Drug Concentration (Cmax) of LY4515100

    Time Frame: Day 1 through Day 11

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

    Day 1 through Day 11

Study Arms (4)

LY4515100 of Part A (SAD)

EXPERIMENTAL

Single-ascending doses of LY4515100 will be given orally

Drug: LY4515100 via SAD

LY4515100 of Part B (MAD)

EXPERIMENTAL

Multiple-ascending doses of LY4515100 will be given orally

Drug: LY4515100 via MAD

Placebo Part A

PLACEBO COMPARATOR

Placebo will be given orally

Drug: LY4515100 via SAD

Placebo Part B

PLACEBO COMPARATOR

Placebo will be given orally

Drug: LY4515100 via MAD

Interventions

LY4515100 via MADDRUG

given orally

LY4515100 of Part B (MAD)Placebo Part B
LY4515100 via SADDRUG

given orally

LY4515100 of Part A (SAD)Placebo Part A

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

RECRUITING

Study Officials

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

    Eli Lilly and Company

    STUDY DIRECTOR

Central Study Contacts

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

CONTACT

1-317-615-4559clinical_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

January 6, 2026

First Posted

January 14, 2026

Study Start

January 15, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)