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First-in-Human safety check for experimental drug LY4178256

NCT ID NCT07698210

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 13, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This early-stage trial evaluates the safety and tolerability of a new drug called LY4178256 in healthy volunteers. Participants receive either the drug or a placebo intravenously, and researchers monitor side effects and how the body processes the drug. The study lasts about 7 months and includes up to 12 visits. Results will help determine if LY4178256 is safe enough to test in people with medical conditions.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LY4178256
What this could lead to
If safe and well-tolerated, this could pave the way for future studies of LY4178256 in people with specific diseases.
What could go wrong
This is an early phase 1 trial in only 88 healthy people, so results may not predict effects in patients. Side effects are unknown and being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 88 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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)).

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Collaborative Neuroscience Network - CNS

    NOT_YET_RECRUITING

    Los Alamitos, California, 90720, United States

  • ICON

    RECRUITING

    Salt Lake City, Utah, 84124, United States

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