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LY3114062

Phase 1

Inflammatory Arthritis | Small molecule | Immunology |Eli Lilly and Company|Last Updated: Jul 17, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

LY3114062 · 1 trial · 1 indication

Phase 1 1
NCT02144272Safety Study to Evaluate LY3114062 in Participants With Inflammatory ArthritisInflammatory Arthritis
COMPLETED41 Analytics
PHASE1COMPLETED
Safety Study to Evaluate LY3114062 in Participants With Inflammatory Arthritis
Inflammatory ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

The Number of Participants with One or More Drug-Related Adverse Events
Baseline to study completion (3 months)

Secondary Endpoints

Pharmacokinetics: Maximum Plasma Concentration (Cmax) of LY3114062
Predose through Day 85, at specified timepoints
Pharmacokinetics: Area Under the Concentration-time curve (AUC) of LY3114062
Predose through Day 85, at specified timepoints
Antibody Production Against LY3114062
Day 1, 8, 15, 29, 85 and early discontinuation
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY3114062 (SC)EXPERIMENTALLY3114062 given as a single subcutaneous (SC) dose, in escalating dose cohorts starting at 2 mg.
LY3114062 (IV)EXPERIMENTALLY3114062 given once intravenous (IV).
PlaceboPLACEBO_COMPARATORPlacebo (sodium chloride injection) given as a single SC dose.

Interventions

NameTypeDescription
LY3114062 SCDRUGLY3114062 administered SC.
PlaceboDRUGPlacebo administered SC.
LY3114062 IVDRUGLY3114062 administered IV.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Signs or symptoms of an inflammatory arthritis for a duration of at least 8 weeks at screening. * Presence of at least 3 out of 66 swollen joints at screening and baseline, as determined by the swollen joint count assessment forms. Exclusion Criteria: * Synthetic disease-mod...

Countries:BulgariaGeorgiaMoldovaRomania
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Frequently asked questions about LY3114062

What is LY3114062 used for?

LY3114062 is an investigational small molecule being developed for the treatment of inflammatory arthritis. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes LY3114062?

LY3114062 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY.

What phase is LY3114062 in?

LY3114062 is in Phase 1 clinical development. A Phase 1 safety study has been completed, but the drug remains investigational and has not received regulatory approval.

What clinical trials is LY3114062 in?

LY3114062 has one completed Phase 1 trial, NCT02144272, which evaluated its safety in participants with inflammatory arthritis. The study enrolled 41 participants across Bulgaria, Georgia, Moldova, and Romania.

Is LY3114062 FDA approved?

LY3114062 is not FDA approved. It is an investigational drug that has completed a Phase 1 safety study and remains in clinical development.