Recent Updates
Recently added Catalysts

LY3954068

Phase 1

Alzheimer Disease | Small molecule | Neurology |Eli Lilly and Company|Last Updated: Aug 24, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

LY3954068 · 1 trial · 1 indication

Phase 1 1
NCT06297590A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's DiseaseAlzheimer Disease
RECRUITING48 Analytics
PHASE1RECRUITING
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Part A: 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 24 and Week 72 (for optional bridging period participants)

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

Part B: 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 52

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

Part A: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax)
Day 1 up to Week 24
Part B: PK: Cmax
Day -1 up to Week 52
Part A: PK: Area Under the Concentration Versus Time Curve (AUC)
Day 1 up to Week 24
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY3954068 (Part A)EXPERIMENTALSingle ascending dose of LY3954068 administered intrathecally (IT)
Placebo (Part A)PLACEBO_COMPARATORSingle ascending dose of placebo administered IT
LY3954068 (Part B)EXPERIMENTALMultiple ascending dose of LY3954068 administered IT
Placebo (Part B)PLACEBO_COMPARATORMultiple ascending dose of placebo administered IT

Interventions

NameTypeDescription
LY3954068DRUGAdministered IT
PlaceboDRUGAdministered IT
Flortaucipir F18DRUGAdministered intravenously (IV) prior to Positron Emission Tomography (PET) scan
Unlock Study Design Details

Eligibility Criteria

Age Range50 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Have a body mass index (BMI) within the range 18 to 40 kilograms per square meter (kg/m²), inclusive, at screening. * Have gradual and progressive change in memory function for greater than or equal to (≥) 6 months as reported by the participant or informant. * Have a mini men...

Countries:United StatesJapanUnited Kingdom
Unlock Eligibility Criteria

Recent Changes (Last 90 Days)

LOWAug 24, 2026NCT06297590lastUpdatePostDate: changed
LOWAug 24, 2026NCT06297590lastUpdatePostDate: changed

Frequently asked questions about LY3954068

What is LY3954068 used for?

LY3954068 is an investigational small molecule being developed for the treatment of Alzheimer's disease. It is currently in Phase 1 clinical development, with a first-in-human study enrolling participants with early symptomatic Alzheimer's disease.

What does LY3954068 target?

The molecular target of LY3954068 has not been disclosed in available information. It is a small molecule being studied for its potential effects in Alzheimer's disease, but its specific mechanism of action is not publicly detailed.

Who makes LY3954068?

LY3954068 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol LLY.

What phase is LY3954068 in?

LY3954068 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A first-in-human study is currently recruiting participants.

What clinical trials is LY3954068 in?

LY3954068 is being evaluated in a Phase 1 clinical trial with the identifier NCT06297590. This is a first-in-human study in participants with early symptomatic Alzheimer's disease, enrolling approximately 48 participants across the United States, Japan, and the United Kingdom.

Is LY3954068 the same as any other drug?

No alternative names for LY3954068 have been disclosed. It is identified solely by its investigational code LY3954068 in clinical trial registries and company communications.