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LY4355756

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Aug 14, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment123

FDA Designations

No designations recorded

Clinical trial landscape

LY4355756 · 1 trial · 1 indication

Phase 1 1
NCT07765498A Study of LY4355756 in Healthy ParticipantsHealthy
NOT YET_RECRUITING123 Analytics
PHASE1NOT YET_RECRUITING
A Study of LY4355756 in Healthy Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline up to the Safety Follow up Visit (6 months)
Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline up to the Safety Follow up Visit (6 months)

Secondary Endpoints

Pharmacokinetics (PK): Area Under the Curve (AUC) of LY4355756
Baseline up to Day 18
PK: Maximum Plasma Concentration (Cmax) of LY4355756
Baseline up to Day 18
PK: AUC of Midazolam
Baseline up to Day 14
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY4355756 Part AEXPERIMENTALSingle-ascending dose (SAD) of LY4355756 administered orally
LY4355756 Part BEXPERIMENTALMultiple-ascending doses (MAD) of LY4355756 administered orally
LY4355756 Part CEXPERIMENTALSingle dose of LY4355756 administered orally in each of three study periods
LY4355756 + Midazolam Part DEXPERIMENTALLY4355756 and midazolam co-administered orally
Midazolam Part DEXPERIMENTALMidazolam administered orally

Interventions

NameTypeDescription
LY4355756DRUGAdministered orally as capsule
MidazolamDRUGAdministered orally as liquid
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, electrocardiogram (ECGs), and vital signs * Have a body mass index within the range 18.0-32.0 kilograms per square meter (kg/m²) (inclusive) * Individual...

Countries:United States
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Recent Changes (Last 90 Days)

LOWAug 14, 2026NCT07765498NEW_TRIAL: changed
LOWAug 14, 2026NCT07765498NEW_TRIAL: changed

Frequently asked questions about LY4355756

What is LY4355756 used for?

LY4355756 is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development, with a single trial evaluating its effects in healthy volunteers. The drug is not approved for any condition and is being tested to assess its safety and tolerability.

Who makes LY4355756?

LY4355756 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting a Phase 1 clinical trial of the drug in healthy participants in the United States.

What phase is LY4355756 in?

LY4355756 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 trial is designed to study the drug in healthy participants and is currently not yet recruiting.

What clinical trials is LY4355756 in?

LY4355756 is being studied in one clinical trial, identified as NCT07765498, titled "A Study of LY4355756 in Healthy Participants." This Phase 1 trial is randomized, double-blind, and controlled, with an enrollment of 123 participants. The trial is based in the United States and is not yet recruiting.

Is LY4355756 the same as any other drug?

LY4355756 is the only name provided for this investigational drug. No alternative names have been associated with it in the available information. It is a distinct small molecule being developed by Eli Lilly and Company for study in healthy participants.