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LY3079514

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: Oct 4, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

LY3079514 · 1 trial · 1 indication

Phase 1 1
NCT02242903A Study of LY3079514 in Healthy ParticipantsHealthy Volunteers
COMPLETED48 Analytics
PHASE1COMPLETED
A Study of LY3079514 in Healthy Participants
Healthy Volunteers
NCT0224290348
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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 to Study Completion (Up to 12 Weeks)

An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of SAEs, regardless of causality, is located in the Reported Adverse Events module.

Secondary Endpoints

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3079514
SC Dosing-Predose,4hr,12hr,24hr,Day(D)3,D5,D8,D11,D15,D22,D29,D43,D57,D85; IV Dosing- D1 and D2 End of Infusion,4hr,12hr,24hr,D3,D8,D15,D22,D29,D36,D43,D57,D85
PK: Area Under the Concentration Curve Zero to Infinity (AUC 0-∞) of LY3079514
SC Dosing-Predose,4hr,12hr,24hr,Day(D)3,D5,D8,D11,D15,D22,D29,D43,D57,D85; IV Dosing- D1 and D2 End of Infusion,4hr,12hr,24hr,D3,D8,D15,D22,D29,D36,D43,D57,D85
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY3079514EXPERIMENTALSingle dose of LY3079514 administered intravenous (IV) or subcutaneous (SC) during a single occasion
PlaceboPLACEBO_COMPARATORSingle dose of placebo matching LY3079514 administered IV infusion or SC injection during a single occasion.

Interventions

NameTypeDescription
LY3079514DRUGAdministered SC
PlaceboDRUGAdministered SC
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Overtly healthy participants as determined by medical history and physical examination * To qualify as Japanese for the purpose of this study, the Japanese participant must be first-generation Japanese * Have a body mass index (BMI) between 18.5 and 32.0 kilograms per square m...

Countries:United States
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Frequently asked questions about LY3079514

What is LY3079514?

LY3079514 is an investigational small molecule being developed by Eli Lilly and Company. It is currently in Phase 1 clinical development for use in healthy volunteers. The drug has completed one Phase 1 trial, which was a randomized, double-blind, placebo-controlled study.

What is LY3079514 used for?

LY3079514 is being studied for use in healthy volunteers. The completed Phase 1 trial, NCT02242903, was designed to evaluate the drug in this population. As an investigational agent, its potential therapeutic applications have not been established, and it remains in early clinical development.

Who makes LY3079514?

LY3079514 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company sponsored the Phase 1 clinical trial of this investigational small molecule.

What phase is LY3079514 in?

LY3079514 is in Phase 1 clinical development. The drug has completed one Phase 1 trial, which was a randomized, double-blind, placebo-controlled study in healthy volunteers. It is not approved and remains investigational, with no active trials currently listed.

What clinical trials is LY3079514 in?

LY3079514 has been studied in one clinical trial, NCT02242903, titled "A Study of LY3079514 in Healthy Participants." This Phase 1 trial was completed and enrolled 48 participants in the United States. The study was randomized, double-blind, and placebo-controlled.

Is LY3079514 the same as other names?

LY3079514 is the primary identifier for this investigational drug. No alternative names have been reported in the available clinical trial information. The drug is solely identified by this code in the completed Phase 1 study.