A Study of LY4515100 in Healthy Participants

NCT07339722 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27789J6V-MC-OIAB
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to assess the safety and tolerability of LY4515100 when given orally to healthy participants. LY4515100 will be given by itself or with other medicines. 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 have 3 parts and will last about 50 days. For each participant in Part A, the study will include a stay in the Clinical Research Unit (CRU) lasting about 6 days. For each participant in Part B, the study will include a stay in the CRU lasting about 15 days. For each participant in Part C, the study will include up to 2 stays in the CRU each lasting between 7-28 days.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of participants with one or more serious adverse event(s) (SAEs) of LY4515100 in Parts A and B

  SAEs of LY4515100

  Day 1 up to Day 30

Secondary Outcomes (7)

• 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

  Day 1 through Day 11

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

  Day 1 through Day 11

• PK: Geometric Means of Area Under the Concentration-Time Curve From 0 to Infinity [AUC(0-∞)] of LY4515100 in Combination with Itraconazole versus LY4515100 Alone

  Day 1 through Day 50

• PK: Geometric Means of Cmax of LY4515100 in Combination with Itraconazole versus LY4515100 Alone

  Day 1 through Day 50

Study Arms (7)

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

LY4515100 and Itraconazole of Part C

EXPERIMENTAL

LY4515100 and Itraconazole will be given orally

Drug: LY4515100; Drug: Itraconazole

LY4515100 and Metformin of Part C

EXPERIMENTAL

LY4515100 and Metformin will be given orally

Drug: LY4515100; Drug: Metformin

LY4515100 and Transporter Substrates or Renal Marker of Part C

EXPERIMENTAL

LY4515100 and Transporter Substrates or Renal Marker will be given either orally or intravenously (IV)

Drug: LY4515100; Drug: Caffeine; Drug: Digoxin; Drug: Iohexol; Drug: Rosuvastatin

Placebo Part A

PLACEBO COMPARATOR

Placebo will be given orally

Drug: Placebo

Placebo Part B

PLACEBO COMPARATOR

Placebo will be given orally

Drug: Placebo

Interventions

LY4515100 via MAD DRUG

given orally

LY4515100 of Part B (MAD)

LY4515100 via SAD DRUG

given orally

LY4515100 of Part A (SAD)

LY4515100 DRUG

given orally

LY4515100 and Itraconazole of Part C; LY4515100 and Metformin of Part C; LY4515100 and Transporter Substrates or Renal Marker of Part C

Itraconazole DRUG

given orally

LY4515100 and Itraconazole of Part C

Caffeine DRUG

given orally

LY4515100 and Transporter Substrates or Renal Marker of Part C

Digoxin DRUG

given orally

LY4515100 and Transporter Substrates or Renal Marker of Part C

Iohexol DRUG

given IV

LY4515100 and Transporter Substrates or Renal Marker of Part C

Metformin DRUG

given orally

LY4515100 and Metformin of Part C

Rosuvastatin DRUG

given orally

LY4515100 and Transporter Substrates or Renal Marker of Part C

Placebo DRUG

given orally

Placebo Part A; Placebo Part B

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 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/m²) (inclusive).
• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

RECRUITING

MeSH Terms

Interventions

Itraconazole; Caffeine; Digoxin; Iohexol; Metformin; Rosuvastatin Calcium

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Xanthines; Alkaloids; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates; Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Biguanides; Guanidines; Amidines; Sulfonamides; Amides; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Sulfones; Sulfur Compounds; Pyrimidines

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
• Masking Details: Part C is Open Label.
• 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): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)