Recent Updates
Recently added Catalysts

LY3361237 -

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Sep 4, 2019

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment64
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03695198A Study of LY3361237 in Healthy ParticipantsPHASE1 COMPLETED 64Oct 26, 2018Aug 29, 2019Sep 4, 20191 United States
Unlock Drug Trial Details
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 through Week 12

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 LY3361237
Predose through Week 12
PK: Area Under the Plasma Concentration Time Curve (AUC) of LY3361237
Predose through Week 12
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3361237 - Subcutaneous (SC)EXPERIMENTALLY3361237 administered SC
Placebo - SCPLACEBO_COMPARATORPlacebo administered SC
LY3361237 - Intravenous (IV)EXPERIMENTALLY3361237 administered IV
Placebo - IVPLACEBO_COMPARATORPlacebo administered IV
Interventions
NameTypeDescription
LY3361237 - SCDRUGLY3361237 administered SC
LY3361237 - IVDRUGLY3361237 administered IV
Placebo - SCDRUGPlacebo administered SC
Placebo - IVDRUGPlacebo administered IV
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males or females, as determined by medical history and physical examination. * To qualify as Japanese for this study, the participant, the participant's biological parents, and all of the participant's biological grandparents must be of exclusive Japanese descent and b...

Countries:United States
Unlock Eligibility Criteria