A Study of LY4178256 in Healthy Participants

NCT07698210 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27875J7G-MC-OEAA
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

Brief Summary

The main purpose of this study is to evaluate how well LY4178256 is tolerated and what side effects may occur in healthy participants. Blood tests will be performed to check how much LY4178256 gets into the bloodstream and how long it takes the body to eliminate it. For each participant, the study will last about 7 months and will include either 7 or 12 visits depending on the assigned treatment.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Part A: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration.

  A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Adverse Events module

  Screening to Day 169

• Part B: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration.

  A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Adverse Events module

  Screening to Day 197

Secondary Outcomes (2)

• Part A: Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY4178256

  Predose up to Day 8

• Part B: Pharmacokinetics: Area Under the Concentration Versus Time Curve (AUC) of LY4178256

  Predose up to Day 64

Study Arms (2)

LY4178256 Part A: Single-Ascending Dose (SAD) (Cohorts 1-6b)

EXPERIMENTAL

LY4178256 or Placebo administered Intravenously (IV)

Drug: LY4178256; Drug: Placebo

LY4178256 Part B: Multiple Ascending Dose (MAD) (Cohorts 1-3)

EXPERIMENTAL

LY4178256 or Placebo administered IV

Drug: LY4178256; Drug: Placebo

Interventions

LY4178256 DRUG

Administered intravenously (IV)

LY4178256 Part A: Single-Ascending Dose (SAD) (Cohorts 1-6b); LY4178256 Part B: Multiple Ascending Dose (MAD) (Cohorts 1-3)

Placebo DRUG

Administered IV

LY4178256 Part A: Single-Ascending Dose (SAD) (Cohorts 1-6b); LY4178256 Part B: Multiple Ascending Dose (MAD) (Cohorts 1-3)

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, and other screening procedures.
• Have a body mass index within the range of 19.0 to 32.0 kilograms per square meter (kg/m²)
• Individuals assigned male at birth willing to practice effective contraception throughout the study and individuals assigned female at birth not of childbearing potential may participate in this trial.

You may not qualify if:

• Have significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, dermatological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the Investigational Medicinal Product (IMP); or of interfering with the interpretation of data.
• Have abnormal blood pressure
• Have a 12-lead electrocardiogram (ECG) abnormality at screening that, in the opinion of the investigator, increases the risks associated with participating in the study, have a mean QT interval corrected using Fridericia's formula (QTcF) of greater than 450 milliseconds (\>450 msec) for males, or \>470 msec for females.
• Regularly use known drugs of abuse or with positive drug results (within the past 3 months).
• Have a positive ethanol breath/urine test result or positive urine drugs of abuse screen at screening or check-in.
• Have hemoglobin level less than 12 grams per deciliter (\<12 g/dL), or evidence of iron deficiency (ferritin less than 30 nanograms per milliliter (\<30 ng/mL), or history or presence of hemoglobinopathy, or history hemolytic anemia. Participants who received transfusion within the past 12 weeks, or requiring regular transfusion should be excluded.
• Have clinically significant abnormal liver function tests at screening: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphate (ALP), or total bilirubin ≥1.5x upper limit normal (ULN). Participants with confirmed Gilbert's syndrome may be enrolled.
• Have significant renal impairment (estimated glomerular filtration rate less than 60 milliliters per minute per square meter (eGFR\<60mL/min/1.73 m ²)).

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

Collaborative Neuroscience Network - CNS

Los Alamitos, California, 90720, United States

Location

ICON

Salt Lake City, Utah, 84124, United States

Location

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
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 13, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)