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LY3540378

Phase 2

Undisclosed | Small molecule | Other |Eli Lilly and Company|Trials Updated: Jun 21, 2022

LY3540378 development status

Highest phase Phase 2 (NCT05592275)
Phase scored for LLYPhase 1
Registered trials 3 across 1 sponsor since Feb 2021

LY3540378 target and mechanism

ModalitySmall molecule

Also known as Volenrelaxin

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment134

FDA Designations

No designations recorded

LY3540378 clinical trials

LY3540378 · 1 trial · 1 indication

Phase 1 1
NCT04768855A Study of LY3540378 in Healthy ParticipantsHealthy
COMPLETED134 Analytics
PHASE1COMPLETED
A Study of LY3540378 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 up to Day 113

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 Concentration (Cmax) of LY3540378
Predose on Day 1 through Day 113
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3540378
Predose on Day 1 through Day 113
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY3540378 (Part A)EXPERIMENTALSingle ascending doses of LY3540378 administered either intravenously (IV) or subcutaneously (SC).
LY3540378 (Part B)EXPERIMENTALMultiple ascending doses of LY3540378 administered SC.
LY3540378 (Part C)EXPERIMENTALMultiple ascending doses of LY3540378 administered SC in Japanese Participants.
LY3540378 (Part D)EXPERIMENTALMultiple ascending doses of LY3540378 administered SC in Chinese Participants.
Placebo (Part A, B, C & D)PLACEBO_COMPARATORPlacebo administered either IV or SC.

Interventions

NameTypeDescription
LY3540378DRUGAdministered IV or SC.
PlaceboDRUGAdministered IV or SC.
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Eligibility Criteria

Age Range21 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Overtly healthy males or females, as determined by medical history and physical examination. * Body mass index (BMI) within the range of 19 to 30 kilograms per meter squared (kg/m²) * For Part C, participants should be first generation Japanese origin. * For Part D, participan...

Countries:United StatesSingapore
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Frequently asked questions about LY3540378

What is LY3540378?

LY3540378 is an investigational small molecule being developed by Eli Lilly and Company. It has been studied in a Phase 1 clinical trial in healthy participants. The specific disease or condition it is intended to treat has not been disclosed, and it is not approved for any use.

Who is developing LY3540378?

LY3540378 is being 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 in healthy volunteers.

What phase is LY3540378 in?

LY3540378 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug remains investigational and has not been approved by the FDA or any other regulatory agency.

What clinical trials has LY3540378 been studied in?

LY3540378 has been evaluated in one completed Phase 1 trial, NCT04768855, titled A Study of LY3540378 in Healthy Participants. The trial enrolled 134 healthy volunteers across the United States and Singapore and used a randomized, double-blind, placebo-controlled design.

What was the design of the LY3540378 Phase 1 trial?

The Phase 1 trial NCT04768855 was a randomized, double-blind, placebo-controlled study of LY3540378 in healthy participants. It enrolled 134 adults aged 21 and older of any sex in the United States and Singapore. The study has been completed.