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LY3361237

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Dec 5, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

LY3361237 · 3 trials · 3 indications

Phase 1 3
NCT04975295A Study of LY3361237 in Participants With PsoriasisPsoriasis
COMPLETED21 Analytics
NCT03933943A Study of LY3361237 in Participants With Systemic Lupus ErythematosusLupus Erythematosus, Systemic
COMPLETED28 Analytics
NCT03695198A Study of LY3361237 in Healthy ParticipantsHealthy
COMPLETED64 Analytics
PHASE1COMPLETED
A Study of LY3361237 in Participants With Psoriasis
PsoriasisUnlock trial analytics
PHASE1COMPLETED
A Study of LY3361237 in Participants With Systemic Lupus Erythematosus
Lupus Erythematosus, SystemicUnlock trial analytics
PHASE1COMPLETED
A Study of LY3361237 in Healthy Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline through Day 253

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

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
Baseline through Day 155

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 with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline through Week 12

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

Secondary Endpoints

Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of LY3361237 During the Dosing Interval
Day 1 predose through Day 253
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3361237
Day 1 predose through Day 155
PK: Area Under the Concentration Versus Time Curve (AUC) Over the Dosing Interval of LY3361237
Day 1 predose through Day 155
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY3361237EXPERIMENTALLY3361237 administered subcutaneously (SC).
PlaceboPLACEBO_COMPARATORPlacebo administered SC.
LY3361237 - Subcutaneous (SC)EXPERIMENTALLY3361237 administered SC
Placebo - SCPLACEBO_COMPARATORPlacebo administered SC
LY3361237 - Intravenous (IV)EXPERIMENTALLY3361237 administered IV
Placebo - IVPLACEBO_COMPARATORPlacebo administered IV

Interventions

NameTypeDescription
LY3361237DRUGAdministered SC
PlaceboDRUGAdministered SC
LY3361237 - SCDRUGLY3361237 administered SC
LY3361237 - IVDRUGLY3361237 administered IV
Placebo - SCDRUGPlacebo administered SC
Placebo - IVDRUGPlacebo administered IV
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Have chronic plaque psoriasis for at least 6 months * Be willing and able to undergo skin biopsies * Body mass index (BMI) within the range of 18 to 40 kilograms per meter squared (kg/m²) * Female participants must agree to use birth control during the study Exclusion Criteri...

Countries:BulgariaHungaryPolandSlovakiaUnited States
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Frequently asked questions about LY3361237

What is LY3361237 used for?

LY3361237 is an investigational small molecule being studied for systemic lupus erythematosus, psoriasis, and in healthy participants. It is in Phase 1 clinical development and is not approved by the FDA.

Who makes LY3361237?

LY3361237 is being developed by Eli Lilly and Company, traded on the New York Stock Exchange under the ticker LLY.

What phase is LY3361237 in?

LY3361237 is in Phase 1 clinical development. All three clinical trials listed for LY3361237 are Phase 1 studies and have been completed.

What clinical trials is LY3361237 in?

LY3361237 has been studied in three completed Phase 1 trials: NCT03695198 in healthy participants, NCT03933943 in participants with systemic lupus erythematosus, and NCT04975295 in participants with psoriasis.

Is LY3361237 the same as any other drug?

LY3361237 is the only name provided for this investigational drug. No alternative names have been reported.