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LY4088044

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Jun 3, 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 Enrollment104
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07090785A Study of LY4088044 in Healthy ParticipantsPHASE1 RECRUITING 104Jul 24, 2025Jul 1, 2027Jun 3, 20266 United States, New Zealand +1
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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 Approximately Day 190

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

Secondary Endpoints
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4088044
Baseline up to Approximately Day 190
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4088044
Baseline up to Approximately Day 190
Pharmacodynamics (PD): Protein Levels in Skin Samples
Baseline up to Approximately Day 190
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY4088044 (Part A)EXPERIMENTALSingle-ascending dose (SAD) of LY4088044 administered intravenously (IV)
Placebo (Part A)PLACEBO_COMPARATORAdministered IV
LY4088044 (Part B)EXPERIMENTALSAD of LY4088044 administered subcutaneously (SC)
Placebo (Part B)PLACEBO_COMPARATORAdministered SC
LY4088044 (Part C)EXPERIMENTALMultiple-ascending doses (MAD) of LY4088044 administered IV
Placebo (Part C)PLACEBO_COMPARATORAdministered IV
Interventions
NameTypeDescription
LY4088044DRUGAdministered IV
PlaceboDRUGAdministered IV
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: * Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring * Have a body mass index (BMI) within the range 18.5 to 30 kilogram per square meter (kg/m²) Exclusion Criteria: * A...

Countries:United StatesNew ZealandSingapore
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Recent Changes (Last 90 Days)
LOWJun 3, 2026NCT07090785lastUpdatePostDate: changed
LOWJun 3, 2026NCT07090785lastUpdatePostDate: changed
LOWMay 26, 2026NCT07090785primaryCompletionDate: changed
LOWMay 24, 2026NCT07090785studyFirstPostDate: changed