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LY3866288

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials2
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

LY3866288 · 2 trials · 1 indication

Phase 1 2
NCT06644378A Study of [14C]-LY3866288 in Healthy ParticipantsHealthy
COMPLETED15 Analytics
NCT06641037A Study of LY3866288 in Healthy ParticipantsHealthy
COMPLETED15 Analytics
PHASE1COMPLETED
A Study of [14C]-LY3866288 in Healthy Participants
HealthyUnlock trial analytics
PHASE1COMPLETED
A Study of LY3866288 in Healthy Participants
HealthyUnlock trial analytics

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 to 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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Frequently asked questions about LY3866288

What is LY3866288?

LY3866288 is an investigational small molecule being developed by Eli Lilly and Company. It is currently in Phase 1 clinical development, studied in healthy participants. Two Phase 1 trials have been completed, with a total enrollment of 30 participants.

What is LY3866288 used for?

LY3866288 is being studied in healthy participants, meaning it is not yet being tested for a specific disease or condition. Its intended therapeutic use has not been established, as it is in early-stage clinical development.

Who makes LY3866288?

LY3866288 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the stock exchange under the ticker symbol LLY.

What phase is LY3866288 in?

LY3866288 is in Phase 1 clinical development. Two Phase 1 trials have been completed, both in healthy participants. It is an investigational drug and has not been approved by regulatory authorities.

What clinical trials is LY3866288 in?

LY3866288 has been studied in two completed Phase 1 trials: NCT06641037, a study in healthy participants, and NCT06644378, a study of [14C]-LY3866288 in healthy participants. Both trials were conducted in the United States.