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LY3839840

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Jun 6, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment140
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06153355A First-In-Human Study of LY3839840 in Healthy ParticipantsPHASE1 COMPLETED 140 — — Dec 4, 2023May 22, 2025Jun 6, 20252 United States
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Study Endpoints
Primary Endpoints
Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration
Baseline up to Week 8

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

Secondary Endpoints
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3839840
Predose on day 1 up to 14 days post dose
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3839840
Predose on day 1 up to 14 days post dose
PK: AUC of Midazolam
Predose on day 1 up to 19 days post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3839840 (Part A)EXPERIMENTALSingle ascending dose of LY3839840 administered orally.
LY3839840 (Part B) Cohort 1-3EXPERIMENTALMultiple ascending dose of LY3839840 administered orally.
LY3839840 (Part B) Cohort 4EXPERIMENTALMultiple ascending dose of LY3839840 administered orally.
LY3839840 (Part B) Optional Cohort 5EXPERIMENTALMultiple ascending dose of LY3839840 administered orally pending data from Cohort 4
LY3839840 (Part C)EXPERIMENTALSingle and multiple dose of LY3839840 administered orally in Chinese participants.
LY3839840 (Part D)EXPERIMENTALMultiple ascending dose of LY3839840 administered orally in Japanese participants.
Placebo (Parts A-D)PLACEBO_COMPARATORPlacebo administered orally.
Midazolam (Part E)EXPERIMENTALMidazolam substrate alone or with LY3839840 administered orally
Interventions
NameTypeDescription
LY3839840DRUGAdministered orally.
PlaceboDRUGAdministered orally.
MidazolamDRUGAdministered orally
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: Healthy men and women. Women may only be included if they are of nonchildbearing potential For Part C: • Part C of the study includes Chinese participants only. To qualify, the participants must be considered as native Chinese, defined as all the participant's biological grand...

Countries:United States
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