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LY3981314

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: May 19, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment76
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07005284A Study of LY3981314 in Healthy ParticipantsPHASE1 ACTIVE NOT_RECRUITING 76 — — Jun 9, 2025Feb 1, 2027May 19, 20261 United States
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Study Endpoints
Primary Endpoints
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline up to Approximately Week 25

A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module

Secondary Endpoints
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3981314
Baseline Up to Approximately Week 25
PK: Maximum Concentration (Cmax) of LY3981314
Baseline up to Approximately Week 25
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3981314 Part AEXPERIMENTALSingle-ascending doses of LY3981314 administered subcutaneously (SC)
LY3981314 Part BEXPERIMENTALSingle dose of LY3981314 administered SC
Placebo Part APLACEBO_COMPARATORPlacebo administered SC
Placebo Part BPLACEBO_COMPARATORPlacebo administered SC
Interventions
NameTypeDescription
LY3981314DRUGAdministered SC
PlaceboDRUGAdministered SC
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead electrocardiogram (ECG) * Individuals assigned male at birth who agree to follow contraceptive requirements, or individuals assig...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT07005284Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT07005284studyFirstPostDate: changed