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LY3114062

Phase 1

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

LY3114062 target and mechanism

ModalitySmall molecule

Also known as LY3114062 SC

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

LY3114062 clinical trials

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 being studied for the treatment of inflammatory arthritis. It is an investigational small molecule developed by Eli Lilly and Company and has been tested in a Phase 1 clinical trial in adults with this condition. It is not yet approved for any use.

Who makes LY3114062?

LY3114062 is developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is the sponsor of the clinical program evaluating the compound in inflammatory arthritis.

What phase is LY3114062 in?

LY3114062 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound remains investigational and has not been approved by the FDA or any other regulatory agency for inflammatory arthritis or any other indication.

What clinical trials is LY3114062 in?

LY3114062 has been evaluated in one completed Phase 1 trial, NCT02144272, titled "Safety Study to Evaluate LY3114062 in Participants With Inflammatory Arthritis." The randomized, double-blind, placebo-controlled study enrolled 41 adults aged 18 years and older across sites in Bulgaria, Georgia, Moldova, and Romania.

Is LY3114062 the same as LY3114062 SC?

Yes. LY3114062 SC is an alternative name for LY3114062, the small molecule being developed by Eli Lilly and Company for inflammatory arthritis. Both names refer to the same investigational compound.

How was the LY3114062 Phase 1 trial designed?

The Phase 1 trial NCT02144272 was a randomized, double-blind, placebo-controlled study of LY3114062 in 41 adults with inflammatory arthritis. Participants were 18 years or older, and the study enrolled patients rather than healthy volunteers. It has been completed and was conducted in Bulgaria, Georgia, Moldova, and Romania.