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LY3375880

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Oct 11, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment163

FDA Designations

No designations recorded

Clinical trial landscape

LY3375880 · 2 trials · 1 indication

Phase 1 2
NCT03913260A Study of Different Injectable Formulations of LY3375880 in Healthy ParticipantsHealthy
COMPLETED83 Analytics
NCT03343587A Study of LY3375880 in Healthy ParticipantsHealthy
COMPLETED80 Analytics
PHASE1COMPLETED
A Study of Different Injectable Formulations of LY3375880 in Healthy Participants
HealthyUnlock trial analytics
PHASE1COMPLETED
A Study of LY3375880 in Healthy Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Visual Analog Scale (VAS) Pain Score
Part A: Within 1-minute post injection

The pain VAS is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's pain is indicated by placing a single mark on the scale from 0 mm (no pain) to 100 mm (severe pain).

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3375880
Part B: Predose through Day 85

PK: Cmax of LY3375880

PK: Area Under the Concentration Versus Time Curve (AUC) of LY3375880
Part B: Predose through Day 85

PK: AUC of LY3375880

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Pre-dose to 3 months after administration of study drug

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Endpoints

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3375880
Pre-dose to 3 months after administration of study drug
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3375880
Pre-dose to 3 months after administration of study drug
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Part A: LY3375880 Formulation AEXPERIMENTALLY3375880 Formulation A administered subcutaneously (SC).
Part A: LY3375880 Formulation BEXPERIMENTALLY3375880 Formulation B administered subcutaneously SC.
Part A: LY3375880 Formulation CEXPERIMENTALLY3375880 Formulation C administered SC.
Part A: Positive ControlPLACEBO_COMPARATORPositive Control (buffer matrix, only) administered SC.
Part B: LY3375880 Test 1EXPERIMENTALLY3375880 Test 1 Formulation administered SC.
Part B: LY3375880 Test 2EXPERIMENTALLY3375880 Test 2 Formulation administered SC.
Part B: LY3375880 Test 3EXPERIMENTALLY3375880 Test 3 Formulation administered SC.
LY3375880 Single DoseEXPERIMENTALSingle dose of LY3375880 administered IV or SC
Placebo Single DosePLACEBO_COMPARATORSingle dose of placebo administered IV or SC
LY3375880 Multiple DoseEXPERIMENTALMultiple doses of LY3375880 administered IV or SC
Placebo Multiple DosePLACEBO_COMPARATORMultiple doses of placebo administered IV or SC

Interventions

NameTypeDescription
LY3375880DRUGAdministered SC
Buffer Matrix (No LY3375880)DRUGAdministered SC
Autoinjector (AI)DEVICEAI used to administer LY3375880 or Buffer Matrix
Manual SyringeDEVICEManual syringe used to inject LY3375880
LY3375880 IVDRUGadministered IV
LY3375880 SCDRUGadministered SC
Placebo IVDRUGadministered IV
Placebo SCDRUGadministered SC
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Are overtly healthy males or females, as determined by medical history and physical examination * Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive * Females who are not of child-bearing potential * Males who agree to use a reliable method of...

Countries:United States
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Frequently asked questions about LY3375880

What is LY3375880?

LY3375880 is an investigational small molecule being developed by Eli Lilly and Company. It is currently in Phase 1 clinical development for healthy participants. The drug is being studied in early-stage trials to evaluate its safety, tolerability, and pharmacokinetics.

What is LY3375880 used for?

LY3375880 is being studied in healthy participants as part of Phase 1 clinical trials. The studies are designed to assess the safety, tolerability, and how the drug behaves in the body. It is not yet approved for any medical condition and remains in clinical development.

Who makes LY3375880?

LY3375880 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 is conducting Phase 1 clinical trials to evaluate the drug in healthy participants.

What phase is LY3375880 in?

LY3375880 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy participants. The drug is investigational and has not been approved by regulatory authorities. Its safety and efficacy are still being evaluated in early-stage studies.

What clinical trials is LY3375880 in?

LY3375880 has been studied in two completed Phase 1 clinical trials. NCT03343587 enrolled 80 healthy participants in the United States, and NCT03913260 enrolled 83 healthy participants to evaluate different injectable formulations. Both trials were placebo-controlled and double-blind.

Is LY3375880 the same as any other drug?

LY3375880 is a unique investigational compound developed by Eli Lilly and Company. No alternative names for this drug have been reported. It is being studied under its own identifier in clinical trials and is not known to be identical to any other marketed medication.