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LY3866288

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Apr 1, 2025

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
RandomizedCONTROLLEDBiomarker
Total Trials2
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06644378A Study of [14C]-LY3866288 in Healthy ParticipantsPHASE1 COMPLETED 15Oct 28, 2024Jan 3, 2025Jan 22, 20251 United States
NCT06641037A Study of LY3866288 in Healthy ParticipantsPHASE1 COMPLETED 15Oct 17, 2024Dec 2, 2024Apr 1, 20251 United States
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Study Endpoints
Primary Endpoints
Part A, Fraction of [14C]-LY3866288 Dose Excreted in Urine (Feur) Expressed as a Percentage of the Total Radioactive Dose Administered
Predose up to Day 21 postdose
Part A, Fraction of Dose [14C]-LY3866288 Excreted in Feces Expressed as a Percentage of the Total Radioactive Dose Administered
Predose up to Day 21 postdose
Part B, Absolute Bioavailability (Fabs) of LY3866288
Predose up to Day 9 postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Time 0 to the Time of the Last Quantifiable Concentration of LY3866288
Baseline to Study Completion (Up to 3 Weeks)

PK: AUC From Time 0 to the Time of the Last Quantifiable Concentration of LY3866288

PK: AUC Extrapolated to Infinity of LY3866288
Baseline to Study Completion (Up to 3 Weeks)
PK: Maximum Concentration (Cmax) of LY3866288
Baseline to Study Completion (Up to 3 Weeks)

PK: Cmax of LY3866288

Secondary Endpoints
Part A: Pharmacokinetics (PK): Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of LY3866288 in Plasma Following a Single Oral Dose of [14C]-LY3866288
Predose up to Day 7 postdose
Part A: Pharmacokinetics (PK): Area Under the Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-∞) of Total Radioactivity in Plasma and Whole Blood Following a Single Oral Dose of [14C]-LY3866288
Predose up to Day 21 postdose
Part A: PK: Maximum Observed Plasma Concentration (Cmax) of LY3866288 in Plasma Following a Single Oral Dose of [14C]-LY3866288
Predose up to Day 7 postdose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Part A: [14C]-LY3866288EXPERIMENTALSingle dose of \[¹⁴C\]-LY3866288 administered orally.
Part B: LY3866288 + [14C]-LY3866288EXPERIMENTALSingle dose of LY3866288 administered orally followed by a single dose of \[¹⁴C\]-LY3866288 administered intravenously (IV).
LY3866288 Cohort 1 (High-Fat Meal)EXPERIMENTALLY3866288 single and multiple capsules administered orally under fasted/fed conditions in cross-over manner within cohort
LY3866288 Cohort 2 (Low-Fat Meal)EXPERIMENTALLY3866288 single and multiple capsules administered orally under fasted/fed conditions in cross-over manner within cohort
Interventions
NameTypeDescription
[14C]-LY3866288DRUGAdministered orally.
LY3866288DRUGAdministered orally.
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male and female participants who are overtly healthy determined by medical history, physical examination, 12-lead ECGs, vital signs measurements, and clinical laboratory evaluations at screening and/or check-in by the investigator * Have Body mass index between 18.0 and 32.0 k...

Countries:United States
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