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LY4355756

Phase 1

Undisclosed | Small molecule | Other |Eli Lilly and Company|Trials Updated: Oct 8, 2026

LY4355756 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 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

LY4355756 clinical trials

LY4355756 · 1 trial · 1 indication

Phase 1 1
NCT07765498A Study of LY4355756 in Healthy ParticipantsHealthy
RECRUITING123 Analytics
PHASE1RECRUITING
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)

LOWOct 8, 2026NCT07765498lastUpdatePostDate: changed
LOWOct 8, 2026NCT07765498lastUpdatePostDate: changed
LOWSep 22, 2026NCT07765498Status: NOT_YET_RECRUITING → RECRUITING
LOWSep 22, 2026NCT07765498Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 14, 2026NCT07765498NEW_TRIAL: changed
LOWAug 14, 2026NCT07765498NEW_TRIAL: changed

Frequently asked questions about LY4355756

What is LY4355756?

LY4355756 is an investigational small molecule drug being developed by Eli Lilly and Company. It is currently in Phase 1 clinical development, with a single recruiting trial in healthy adult participants. The specific disease or condition it is intended to treat has not been disclosed.

Who makes LY4355756?

LY4355756 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 drug in healthy participants.

What phase is LY4355756 in?

LY4355756 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial is currently recruiting, and no trials for LY4355756 have been completed.

What clinical trials is LY4355756 in?

LY4355756 is being studied in one Phase 1 trial, NCT07765498, titled A Study of LY4355756 in Healthy Participants. The trial is recruiting in the United States, plans to enroll 123 participants aged 18 years and older, and is randomized, double-blind, and controlled.

Is LY4355756 tested in healthy volunteers?

Yes. The Phase 1 trial of LY4355756, NCT07765498, enrolls healthy adult volunteers rather than patients with a specific disease. It is a randomized, double-blind, controlled study with a planned enrollment of 123 participants, and it is currently recruiting in the United States.