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RecruitingPhase 1

A Study of LY4405094 in Healthy Participants and Participants With Alzheimer's Disease

A Placebo-Controlled, Single- and Multiple-Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4405094 in Healthy Participants and Participants With Alzheimer's Disease

Asset

LY4405094

Listed sites

18

Recruiting sites

1

Enrollment

68

estimated

Study population

Alzheimer’s disease

Key I/E criterion

•Age 18-85

Primary endpoint

•Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID27910
NCT IDNCT07787182

Timeline

Milestones

Study start2025-10-14actual
Study first posted2026-08-26actual
Last update posted2026-10-22actual
Primary completion2028-01estimated (month precision)
Study completion2028-01estimated (month precision)

Assets

Drug assets

LY4405094

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age18 Years
Maximum age85 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•Participants must meet eligibility criteria in the ATMP screening protocol before entry into the treatment study

Exclusion criteria

•Have known allergies to LY4405094, related compounds (including remternetug), or any components of the formulation, including LY4405094.
•Have known allergic reactions to adhesive or hydrogels or a family history of adhesive skin allergies.

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
3
Amyloid biomarkers
1
Fluid / digital biomarkers
1

Amyloid biomarkers

1 endpoint
Secondary/protocol endpoint

Change from Baseline of Amyloid Plaque levels as Assessed by Amyloid Positron Emission Tomography (PET) in Participants with AD

Time frame:Baseline through Study Completion (25 Weeks)

change from baseline, improvement

Fluid / digital biomarkers

1 endpoint
Secondary/protocol endpoint

Change from Baseline of Cerebrospinal Fluid (CSF) Concentration of LY4405094 in Healthy Participants

Time frame:Baseline through Study Completion (Week 13)

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame:Baseline up to 25 Weeks

event count, event

Secondary/protocol endpoint

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4405094 in Healthy Participants

Time frame:Baseline through Study Completion (Week 13)

concentration, descriptive

Secondary/protocol endpoint

PK: Area Under the Concentration Versus Time Curve (AUC) of LY4405094 in Participants with Alzheimer's Disease (AD)

Time frame:Baseline through Study Completion (25 Weeks)

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.