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LY4178256

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: Aug 20, 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

Clinical trial landscape

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
LOWJul 13, 2026NCT07698210NEW_TRIAL: changed
LOWJul 13, 2026NCT07698210NEW_TRIAL: changed

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 for use in healthy volunteers. The drug is being studied to evaluate its safety, tolerability, and pharmacokinetics in a clinical trial setting.

What is LY4178256 used for?

LY4178256 is being studied for use in healthy volunteers. The ongoing Phase 1 trial aims to assess the drug's safety, tolerability, and how it is processed by the body. It is not yet approved for any medical condition and remains in early-stage clinical development.

Who makes LY4178256?

LY4178256 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the stock exchange under the ticker symbol LLY. The company is conducting a Phase 1 clinical trial to evaluate the drug in healthy participants.

What phase is LY4178256 in?

LY4178256 is in Phase 1 clinical development. The drug is currently being studied in a Phase 1 trial that is recruiting participants. It is an investigational drug and has not been approved by regulatory authorities for any use.

What clinical trials is LY4178256 in?

LY4178256 is being studied in a Phase 1 clinical trial with the identifier NCT07698210. This trial is titled 'A Study of LY4178256 in Healthy Participants' and is currently recruiting in the United States. The study is randomized, double-blind, and controlled, with an enrollment of 88 participants.