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LY3839840

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Jun 6, 2025

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment140

FDA Designations

No designations recorded

Clinical trial landscape

LY3839840 · 1 trial · 1 indication

Phase 1 1
NCT06153355A First-In-Human Study of LY3839840 in Healthy ParticipantsHealthy
COMPLETED140 Analytics
PHASE1COMPLETED
A First-In-Human Study of LY3839840 in Healthy Participants
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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 to 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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Frequently asked questions about LY3839840

What is LY3839840?

LY3839840 is an investigational small molecule being developed by Eli Lilly and Company. It is currently in Phase 1 clinical development. The drug has been studied in healthy participants, and its therapeutic area is classified as Other. It is not yet approved and remains under clinical investigation.

What is LY3839840 used for?

LY3839840 is being studied for use in healthy participants. The Phase 1 trial, NCT06153355, is a first-in-human study designed to evaluate the drug in healthy volunteers. The specific condition it is intended to treat has not been disclosed, as the study focuses on healthy individuals.

Who makes LY3839840?

LY3839840 is developed by Eli Lilly and Company, a pharmaceutical company traded on the stock exchange under the ticker LLY. The company is conducting clinical research on this investigational drug, which is currently in Phase 1 development.

What phase is LY3839840 in?

LY3839840 is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. It is being studied in a first-in-human trial involving healthy participants to assess its safety and tolerability.

What clinical trials is LY3839840 in?

LY3839840 has one completed clinical trial, NCT06153355, titled "A First-In-Human Study of LY3839840 in Healthy Participants." This Phase 1 trial enrolled 140 participants in the United States, was randomized, double-blind, and placebo-controlled. The study included healthy volunteers aged 18 years and older.