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LY3375880

Phase 2

Undisclosed | Small molecule | Other |Eli Lilly and Company|Trials Updated: Oct 11, 2019

LY3375880 development status

Highest phase Phase 2 (NCT03831191)
Phase scored for LLYPhase 1
Registered trials 2 across 1 sponsor since Feb 2019

LY3375880 target and mechanism

ModalitySmall molecule

Also known as LY3375880 IV

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

LY3375880 clinical trials

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 developed by Eli Lilly and Company. It has been studied in Phase 1 clinical trials in healthy adult participants in the United States. The specific disease or condition it is intended to treat has not been publicly disclosed.

Who makes LY3375880?

LY3375880 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly sponsored both Phase 1 trials of the compound conducted in the United States.

What phase is LY3375880 in?

LY3375880 is in Phase 1 development. Two Phase 1 trials have been completed, and no active trials are currently listed. The compound has been tested only in healthy volunteers, and no later-stage studies have been reported.

What clinical trials is LY3375880 in?

LY3375880 has been evaluated in two completed Phase 1 trials: NCT03913260, which studied different injectable formulations in 83 healthy participants, and NCT03343587, which studied the drug in 80 healthy participants. Both were conducted in the United States and together enrolled 163 participants.

Is LY3375880 the same as LY3375880 IV?

Yes. LY3375880 IV is an alternative name for LY3375880, reflecting the injectable formulations studied in its clinical program. Searches for either name refer to the same Eli Lilly investigational small molecule.

How was LY3375880 studied in its clinical trials?

Both Phase 1 trials of LY3375880 were randomized, double-blind, and placebo-controlled, enrolling a total of 163 healthy adult participants aged 18 and older. One trial compared different injectable formulations, and the other evaluated the drug in healthy participants.