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LY3454738

Phase 1

Dermatitis, Atopic | Small molecule | Dermatology |Eli Lilly and Company|Last Updated: May 30, 2024

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment128

FDA Designations

No designations recorded

Clinical trial landscape

LY3454738 · 2 trials · 2 indications

Phase 1 2
NCT06173895A Relative Bioavailability Study of LY3454738 in Healthy ParticipantsHealthy
COMPLETED30 Analytics
NCT03750643A Study of LY3454738 in Healthy Participants and Participants With Atopic DermatitisDermatitis, Atopic
COMPLETED128 Analytics
PHASE1COMPLETED
A Relative Bioavailability Study of LY3454738 in Healthy Participants
HealthyUnlock trial analytics
PHASE1COMPLETED
A Study of LY3454738 in Healthy Participants and Participants With Atopic Dermatitis
Dermatitis, AtopicUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3454738
Predose on day 1 up to 85 days post dose

PK: Cmax of LY3454738

PK: Area Under the Concentration Versus Time Curve (AUC) of LY3454738
Predose on day 1 up to 85 days post dose

PK: AUC of LY3454738

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 Week 24

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Number of Participants Achieving a Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) Score of 0 or 1 with a ≥ 2-point Improvement from Baseline
Week 12

The vIGA-AD measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification

Secondary Endpoints

Maximum Observed Drug Concentration (Cmax) of LY3454738
Day 1 through Day 85 (Day 99 for Part C)
Area Under the Concentration-Versus-Time Curve (AUC) of LY3454738
Day 1 through Day 85 (Day 99 for Part C)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY3454738 (Test Formulation)EXPERIMENTAL -
LY3454738 (Reference Formulation)EXPERIMENTAL -
LY3454738 - Part AEXPERIMENTALEscalating doses of LY3454738 administered intravenously (IV) or subcutaneously (SC) to healthy participants
Placebo - Part APLACEBO_COMPARATORPlacebo administered IV to healthy participants
LY3454738 - Part BEXPERIMENTALLY3454738 administered IV to healthy participants
Placebo - Part BPLACEBO_COMPARATORPlacebo administered IV to healthy participants
LY3454738 - Part CEXPERIMENTALLY3454738 administered IV to participants with atopic dermatitis (AD)
Placebo - Part CPLACEBO_COMPARATORPlacebo administered IV to participants with AD

Interventions

NameTypeDescription
LY3454738DRUGAdministered subcutaneously (SC)
PlaceboDRUGAdministered IV
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Participants who are overtly healthy as determined by medical history and physical examination. * Have body mass index (BMI) between 18.0 and 28.0 kilograms per meter squared (kg/m²), inclusive, at screening. Exclusion Criteria: * Have a significant history of or current car...

Countries:United StatesPuerto Rico
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Frequently asked questions about LY3454738

What is LY3454738 used for?

LY3454738 is an investigational small molecule being studied for atopic dermatitis. It has been evaluated in clinical trials involving healthy participants and participants with atopic dermatitis. The drug is in Phase 1 development and is not approved by the FDA.

Who makes LY3454738?

LY3454738 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker LLY. The drug is currently in Phase 1 clinical development for atopic dermatitis.

What phase is LY3454738 in?

LY3454738 is in Phase 1 clinical development. It has completed two Phase 1 trials, including one in healthy participants and participants with atopic dermatitis, and another relative bioavailability study in healthy participants. The drug remains investigational.

What clinical trials has LY3454738 been in?

LY3454738 has been studied in two completed Phase 1 trials. NCT03750643 evaluated the drug in healthy participants and participants with atopic dermatitis, enrolling 128 participants in the United States and Puerto Rico. NCT06173895 was a relative bioavailability study in 30 healthy participants in the United States.

Is LY3454738 the same as any other drug?

LY3454738 is the drug name used in clinical trials for this investigational small molecule. No alternative names have been reported for this compound in the available clinical trial information.