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LY4405094

Phase 1

Alzheimer Disease | Small molecule | Neurology |Eli Lilly and Company|Last Updated: Aug 27, 2026

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment179

FDA Designations

No designations recorded

Clinical trial landscape

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
NOT YET_RECRUITING179 Analytics
NCT07787182A Study of LY4405094 in Healthy Participants and Participants With Alzheimer's DiseaseHealthy Volunteers
NOT YET_RECRUITING68 Analytics
PHASE1NOT YET_RECRUITING
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 Sites10

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 States
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Recent Changes (Last 90 Days)

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 the treatment of Alzheimer's disease and for use in healthy volunteers. It is being evaluated in early-stage clinical trials to assess its effects on amyloid plaques, which are associated with Alzheimer's disease.

Who is developing LY4405094?

LY4405094 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is LY4405094 in?

LY4405094 is in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The ongoing Phase 1 trials are designed to evaluate its safety, tolerability, and pharmacokinetics in healthy participants and those with Alzheimer's disease.

What clinical trials is LY4405094 in?

LY4405094 is being studied in two Phase 1 clinical trials. One trial, NCT07787169, is a master protocol studying multiple amyloid-targeting therapies in healthy participants and participants with Alzheimer's disease. Another trial, NCT07787182, is a dedicated study of LY4405094 in the same populations. Both trials are not yet recruiting and are based in the United States.

How does LY4405094 work?

LY4405094 is designed to target amyloid, a protein that forms plaques in the brains of people with Alzheimer's disease. By targeting amyloid, the drug aims to reduce or clear these plaques, potentially slowing the progression of the disease. This mechanism is being investigated in early-stage clinical trials.

Is LY4405094 the same as other amyloid-targeting therapies?

LY4405094 is a distinct investigational drug being developed by Eli Lilly. It is part of a master protocol that studies multiple amyloid-targeting therapies, but LY4405094 itself is a unique compound. No alternative names for LY4405094 have been disclosed in the clinical trial information.