A Study of LY4178256 in Healthy Participants

This study is looking for healthy volunteers, aged 18 to 65, to help understand a new drug called LY4178256. The main goal is to see how well your body tolerates LY4178256 and what side effects might occur. Some participants will receive LY4178256 through an IV (into a vein), while others will receive a placebo (an inactive substance). Researchers will also take blood tests to see how much of the drug enters your bloodstream and how quickly your body removes it. The study will last about 7 months for each participant, with either 7 or 12 visits depending on your assigned treatment.

Study design: This is an interventional study planning to enroll 88 healthy participants. It compares LY4178256 given intravenously with a placebo given intravenously.
What's involved: You would participate for about 7 months, with either 7 or 12 visits. These visits will include medical evaluations, physical exams, and blood tests.
Compensation: Not stated in the trial record.
Follow-up: Participants will be monitored for serious side effects for up to 169 or 197 days, depending on the study part.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

A Study of LY4178256 in Healthy Participants

Recruiting

PHASE1Ages 18–65InterventionalBasic science

Eli Lilly and Company

~88 participants

Updated 2026-08-20 on ClinicalTrials.gov

What's tested:LY4178256Placebo

At a glance

Recruiting sites

1 of 2 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

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.

Measured over Screening to Day 169

+1 more outcome measured

Conditions

Healthy Volunteers

NCT07698210

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

Collaborative Neuroscience Network - CNS
Los Alamitos, Californiastudy coordinator listed
Not yet recruiting
ICON
Salt Lake City, Utahstudy coordinator listed
Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

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) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

[email protected]

1-317-615-4559

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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.

Exclusion

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)).

What this trial measures

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.Screening to Day 169
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Adverse Events module
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.Screening to Day 197
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Adverse Events module

Trialytics