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LY4405094

Phase 1

Alzheimer Disease | Small molecule | Neurology |Eli Lilly and Company|Trials Updated: Oct 8, 2026

LY4405094 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Aug 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment247

FDA Designations

No designations recorded

LY4405094 clinical trials

LY4405094 · 2 trials · 4 indications

Phase 1 2
NCT07787169A Master Protocol Studying Multiple Amyloid-Targeting Therapies in Healthy Participants and Participants With Alzheimer's DiseaseAlzheimer Disease
RECRUITING179 Analytics
NCT07787182A Study of LY4405094 in Healthy Participants and Participants With Alzheimer's DiseaseHealthy Volunteers
NOT YET_RECRUITING68 Analytics
PHASE1RECRUITING
A Master Protocol Studying Multiple Amyloid-Targeting Therapies in Healthy Participants and Participants With Alzheimer's Disease
Alzheimer DiseaseUnlock trial analytics
PHASE1NOT YET_RECRUITING
A Study of LY4405094 in Healthy Participants and Participants With Alzheimer's Disease
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

The number of participants allocated to each substudy
Baseline up to Day 160
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline up to 25 Weeks

Secondary Endpoints

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4405094 in Healthy Participants
Baseline through Study Completion (Week 13)
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4405094 in Participants with Alzheimer's Disease (AD)
Baseline through Study Completion (25 Weeks)
Change from Baseline of Cerebrospinal Fluid (CSF) Concentration of LY4405094 in Healthy Participants
Baseline through Study Completion (Week 13)
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeSCREENING

Treatment Arms

ArmTypeDescription
LY4405094 Study AT01 (Healthy ISA)EXPERIMENTALLY4405094 or placebo administered intravenously (IV) or subcutaneously (SC) in healthy volunteers.
LY4405094 Study AT01 (AD ISA)EXPERIMENTALLY4405094 or placebo administered IV to participants with AD. Florbetapir F 18 or Florbetaben F 18 will be administered IV during amyloid positron emission tomography (PET) scan.
LY4405094 Part A: Single-Ascending Dose (SAD)EXPERIMENTALLY4405094 administered intravenously (IV) or subcutaneously (SC) in healthy volunteers.
Placebo Part APLACEBO_COMPARATORPlacebo administered IV or SC in healthy volunteers.
LY4405094 Part B: Multiple Ascending Dose (MAD)EXPERIMENTALLY4405094 administered IV to participants with AD. Florbetapir F 18 or Florbetaben F 18 will be administered IV during amyloid positron emission tomography (PET) scan.
Placebo Part BPLACEBO_COMPARATORPlacebo administered IV to participants with AD. Florbetapir F 18 or Florbetaben F 18 will be administered IV during amyloid positron emission tomography (PET) scan.

Interventions

NameTypeDescription
LY4405094DRUGAdministered intravenously (IV)
PlaceboDRUGAdministered IV
Florbetapir F18OTHERAdministered IV
Florbetaben F 18OTHERAdministered IV
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Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersYes
Study Sites18

Participants must meet eligibility criteria below. Additional criteria are specified in the substudy to which the participant will enroll. Inclusion Criteria for Healthy Participants: * Are between 18 and 45 years of age * Have a body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg...

Countries:United StatesChinaJapan
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Recent Changes (Last 90 Days)

LOWOct 8, 2026NCT07787169Status: NOT_YET_RECRUITING → RECRUITING
LOWOct 8, 2026NCT07787169Status: NOT_YET_RECRUITING → RECRUITING
LOWSep 22, 2026NCT07787182lastUpdatePostDate: changed
LOWSep 22, 2026NCT07787169lastUpdatePostDate: changed
LOWSep 22, 2026NCT07787182lastUpdatePostDate: changed
LOWSep 22, 2026NCT07787169lastUpdatePostDate: changed
LOWAug 27, 2026NCT07787169lastUpdatePostDate: changed
LOWAug 27, 2026NCT07787169lastUpdatePostDate: changed
LOWAug 26, 2026NCT07787182NEW_TRIAL: changed
LOWAug 26, 2026NCT07787169NEW_TRIAL: changed
LOWAug 26, 2026NCT07787182NEW_TRIAL: changed
LOWAug 26, 2026NCT07787169NEW_TRIAL: changed

Frequently asked questions about LY4405094

What is LY4405094 used for?

LY4405094 is an investigational small molecule being studied for Alzheimer disease. It is also being evaluated in healthy volunteers as part of early-stage research. Eli Lilly and Company is developing the drug, which is currently in Phase 1 clinical development and has not been approved for any indication.

Who is developing LY4405094?

LY4405094 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. The company is running two Phase 1 trials of the drug in the United States, China, and Japan.

What phase is LY4405094 in?

LY4405094 is in Phase 1 clinical development. Two Phase 1 trials are registered, both currently active, with one recruiting and one not yet recruiting. The drug is investigational and has not been approved by the FDA for any use.

What clinical trials is LY4405094 in?

LY4405094 is being studied in two Phase 1 trials. NCT07787182 is a study in healthy participants and participants with Alzheimer disease that is not yet recruiting. NCT07787169 is a master protocol studying multiple amyloid-targeting therapies in healthy participants and participants with Alzheimer disease and is currently recruiting.

How many participants are enrolled in LY4405094 trials?

The two Phase 1 trials of LY4405094 have a combined planned enrollment of 247 participants. NCT07787182 plans to enroll 68 participants, and NCT07787169 plans to enroll 179 participants. Both trials are randomized, double-blind, and placebo-controlled.