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LY3079514

Phase 1

Undisclosed | Small molecule | Other |Eli Lilly and Company|Trials Updated: Oct 4, 2018

LY3079514 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2014

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

LY3079514 clinical trials

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 VolunteersUnlock trial analytics

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 developed by Eli Lilly and Company. It has been studied in a Phase 1 clinical trial in healthy adult volunteers in the United States. The specific disease or condition it is intended to treat has not been publicly disclosed, and it remains in early clinical development.

Who makes LY3079514?

LY3079514 is made and developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored the Phase 1 study of the compound conducted in healthy participants in the United States.

What phase is LY3079514 in?

LY3079514 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The study enrolled 48 healthy participants and was randomized, double-blind, and placebo-controlled. The compound has not been approved by the FDA and remains investigational.

What clinical trials is LY3079514 in?

LY3079514 has been evaluated in one completed Phase 1 trial, NCT02242903, titled A Study of LY3079514 in Healthy Participants. The trial enrolled 48 healthy volunteers aged 18 years and older in the United States. It used a randomized, double-blind, placebo-controlled design. No active trials of LY3079514 are currently listed.

What is LY3079514 used for?

LY3079514 has been studied only in healthy volunteers in a Phase 1 trial, so no therapeutic use has been established. The target indication for LY3079514 has not been publicly disclosed. It is an investigational small molecule and is not approved for any condition.