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LY4178256

Phase 1

Undisclosed | Small molecule | Other |Eli Lilly and Company|Trials Updated: Aug 20, 2026

LY4178256 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment88

FDA Designations

No designations recorded

LY4178256 clinical trials

LY4178256 · 1 trial · 1 indication

Phase 1 1
NCT07698210A Study of LY4178256 in Healthy ParticipantsHealthy Volunteers
RECRUITING88 Analytics
PHASE1RECRUITING
A Study of LY4178256 in Healthy Participants
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY4178256 Part A: Single-Ascending Dose (SAD) (Cohorts 1-6b)EXPERIMENTALLY4178256 or Placebo administered Intravenously (IV)
LY4178256 Part B: Multiple Ascending Dose (MAD) (Cohorts 1-3)EXPERIMENTALLY4178256 or Placebo administered IV

Interventions

NameTypeDescription
LY4178256DRUGAdministered intravenously (IV)
PlaceboDRUGAdministered IV
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

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...

Countries:United States
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Recent Changes (Last 90 Days)

LOWAug 20, 2026NCT07698210Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07698210Status: NOT_YET_RECRUITING → RECRUITING

Frequently asked questions about LY4178256

What is LY4178256?

LY4178256 is an investigational small molecule being developed by Eli Lilly and Company. It is currently in Phase 1 clinical development, with a single recruiting study in healthy adult volunteers. No therapeutic indication for LY4178256 has been disclosed, so its intended use has not been publicly announced.

Who makes LY4178256?

LY4178256 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the Phase 1 study evaluating the compound in healthy participants.

What phase is LY4178256 in?

LY4178256 is in Phase 1 clinical development. It has one active, recruiting trial and no completed trials. Because it remains investigational, LY4178256 has not been approved by the FDA for any indication.

What clinical trials is LY4178256 in?

LY4178256 is being studied in one Phase 1 trial, NCT07698210, titled A Study of LY4178256 in Healthy Participants. The trial is recruiting 88 healthy adult volunteers in the United States. It is randomized, double-blind, and controlled, and is open to participants 18 years and older of all sexes.

Is LY4178256 tested in healthy volunteers?

Yes. The Phase 1 trial of LY4178256, NCT07698210, enrolls healthy volunteers rather than patients with a specific disease. The study is recruiting 88 participants aged 18 years and older in the United States, and it is randomized, double-blind, and controlled.