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LY4066708

Phase 1

Healthy | Small molecule | Oncology |Eli Lilly and Company|Last Updated: Mar 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
NCT07046559A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY4066708 in Healthy ParticipantsPHASE1 RECRUITING 104May 13, 2025Sep 1, 2027Mar 3, 20261 United Kingdom
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Study Endpoints
Primary Endpoints
Part A: Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline up to Week 12

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Adverse Events module

Part B: Number of Participants with One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Screening to Day 22

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Adverse Events module

Secondary Endpoints
Part A: Pharmacokinetics (PK)- Area Under the Plasma Concentration Versus Time Curve (AUC0-168)
Predose up to day 15
Part B: Pharmacokinetics (PK)- AUC0-168
Day 1 up to day 7
Part A: Pharmacokinetics (PK)- Maximum Observed Drug Concentration (Cmax)
Predose up to day 15
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Part A Cohort 1: Single-Ascending Dose (SAD)- LY4066708EXPERIMENTALLY4066708 administered by intravenous (IV) injection
Part A Cohort 2: SAD- LY4066708EXPERIMENTALLY4066708 administered by IV injection
Part A Cohort 3A: SAD- LY4066708EXPERIMENTALLY4066708 administered by subcutaneous (SC) injection
Part A Cohort 3B: SAD- LY4066708EXPERIMENTALLY4066708 administered by SC injection
Part A Cohort 4: SAD- LY4066708EXPERIMENTALLY4066708 administered by IV injection
Part A Cohort 5: SAD- LY4066708EXPERIMENTALLY4066708 administered by IV injection
Part A Cohort 5A: SAD- LY4066708EXPERIMENTALLY4066708 administered by IV injection
Part A Cohort 6A: SAD- LY4066708EXPERIMENTALLY4066708 administered by IV injection
Part A Cohort 6: SAD- LY4066708EXPERIMENTALLY4066708 administered by IV injection
Part B Cohort 1: Multiple-Ascending Dose (MAD)- LY4066708EXPERIMENTALLY4066708 administered by IV injection
Part B Cohort 2: MAD- LY4066708EXPERIMENTALLY4066708 administered by IV injection
Part B Cohort 3: MAD- LY4066708EXPERIMENTALLY4066708 administered by IV injection
Part B Cohort 4: MAD- LY4066708EXPERIMENTALLY4066708 administered by IV injection
PlaceboPLACEBO_COMPARATORPlacebo administered by IV injection
Placebo- Part A Cohort 3A and Part A Cohort 3B.PLACEBO_COMPARATORPlacebo administered by SC injection
Interventions
NameTypeDescription
LY4066708DRUGAdministered IV
PlaceboDRUGAdministered IV
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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, and cardiac monitoring. * Japanese Participants Only: To qualify as a participant of first-generation Japanese origin, the participant, the participant's ...

Countries:United Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07046559primaryCompletionDate: changed
LOWMay 24, 2026NCT07046559studyFirstPostDate: changed