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LY3127760

Phase 1

Healthy Volunteers | Small molecule | Other |Eli Lilly and Company|Last Updated: Jun 7, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

LY3127760 · 1 trial · 1 indication

Phase 1 1
NCT01968070A Study of LY3127760 in Healthy ParticipantsHealthy Volunteers
COMPLETED80 Analytics
PHASE1COMPLETED
A Study of LY3127760 in Healthy Participants
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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 Day 42)

Data presented are the number of participants who experienced SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and all other non-serious Adverse Event(s) (AEs), regardless of causality, is located in the Reported Adverse Event module.

Secondary Endpoints

Pharmacokinetics (PK): Area Under the Concentration Curve Versus Time Curve From Zero to Infinity (AUC 0-∞) of Single Dose LY3127760
Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours
PK: Maximum Observed Concentration (Cmax) of Single Dose LY3127760
Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours
PK: Time of Maximum Observed Concentration (Tmax) of Single Dose LY3127760
Day 1: -1, 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24, 36, 48, 96, and 144 Hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY3127760 (Single)EXPERIMENTALSingle oral dose of up to 900 milligram (mg) LY3127760 administered in up to 3 of 3 study periods.
Placebo (Single)PLACEBO_COMPARATORSingle oral dose of placebo administered in up to 2 of 3 study periods. Placebo matches LY3127760 in appearance.
LY3127760 (Multiple)EXPERIMENTALMultiple ascending oral doses of up to 900 mg LY3127760 administered once or twice daily (QD or BID) for 28 days.
Placebo (Multiple)PLACEBO_COMPARATORMultiple oral doses of placebo administered QD or BID for 28 days. Placebo matches LY3127760 in appearance.
Celecoxib (Multiple)ACTIVE_COMPARATORMultiple oral doses of 400 mg celecoxib administered QD for 28 days.

Interventions

NameTypeDescription
LY3127760DRUGAdministered orally
CelecoxibDRUGAdministered orally
PlaceboDRUGAdministered orally
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Overtly healthy males or females as determined by medical history and physical examination * Male participants agree to use a reliable method of birth control during the study and 3 months following the last dose of the investigational product * Female participants not of chil...

Countries:United States
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Frequently asked questions about LY3127760

What is LY3127760?

LY3127760 is an investigational small molecule being developed by Eli Lilly and Company. It is currently in Phase 1 clinical development, studied in healthy volunteers. The drug has completed one clinical trial with 80 participants.

What does LY3127760 target?

LY3127760 is a small molecule, but its specific molecular target has not been disclosed. The drug is being studied in healthy volunteers to evaluate its safety and tolerability, though its mechanism of action is not publicly detailed.

Who makes LY3127760?

LY3127760 is developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The drug is currently in Phase 1 clinical development.

What phase is LY3127760 in?

LY3127760 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. One Phase 1 trial has been completed, and the drug is no longer in active clinical trials.

What clinical trials is LY3127760 in?

LY3127760 has one completed clinical trial, NCT01968070, titled "A Study of LY3127760 in Healthy Participants." This Phase 1 study enrolled 80 healthy volunteers in the United States and was placebo-controlled, randomized, and double-blind.

Is LY3127760 FDA approved?

LY3127760 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial in healthy volunteers. The drug is still in clinical development and has not been approved for any medical use.