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LY4006895

Phase 1

Alzheimer Disease | Small molecule | Neurology |Eli Lilly and Company|Last Updated: Jun 4, 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 Enrollment128
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06657768A Study of LY4006895 in Healthy Participants With Early Symptomatic Alzheimer's Disease (AD)PHASE1 RECRUITING 128Oct 29, 2024Jul 1, 2027Jun 4, 202613 United States, Japan
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Study Endpoints
Primary Endpoints
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Discontinuations due to Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline to Study Completion (Up to 61 Weeks)

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

Secondary Endpoints
PK: Maximum Concentration (Cmax) of LY4006895
Baseline to Study Completion (Up to 61 Weeks)
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4006895
Baseline to Study Completion (Up to 61 Weeks)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY4006895 of Part A (SAD)EXPERIMENTALSingle-ascending doses of LY4006895 administered intravenously (IV)
Placebo Part APLACEBO_COMPARATORPlacebo administered IV
LY4006895 of Part B (MAD)EXPERIMENTALMultiple-ascending doses of LY4006895 will be administered IV
Placebo Part BPLACEBO_COMPARATORPlacebo administered IV
Interventions
NameTypeDescription
LY4006895DRUGAdministered IV
PlaceboDRUGAdministered IV
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Eligibility Criteria
Age Range45 Years — 85 Years
SexALL
Healthy VolunteersYes
Study Sites13

Inclusion Criteria for Part A and Part B: \- Have a body mass index (BMI) within the range 18 to 40 kilogram per square meter (kg/m²) For Part A: * Are overtly healthy as determined by medical evaluation. Rescreening is not allowed in this study For Part B: * Have early symptomatic AD, as defin...

Countries:United StatesJapan
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Recent Changes (Last 90 Days)
LOWJun 4, 2026NCT06657768lastUpdatePostDate: changed
LOWJun 4, 2026NCT06657768lastUpdatePostDate: changed
LOWJun 4, 2026NCT06657768lastUpdatePostDate: changed
LOWJun 4, 2026NCT06657768lastUpdatePostDate: changed
LOWMay 26, 2026NCT06657768primaryCompletionDate: changed
LOWMay 24, 2026NCT06657768studyFirstPostDate: changed