Not yet recruitingPhase 1

A Study of LY4560736 in Healthy Participants and Participants With Alzheimer's Disease (AD)

A Placebo-Controlled, Single- and Multiple-Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4560736 in Healthy Participants and Participants With Alzheimer's Disease

Lead sponsor

Eli Lilly and Company

Asset

LY4560736

Listed sites

Recruiting sites

Enrollment

111

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 ID27911

NCT IDNCT07843459

Timeline

Milestones

Study first posted2026-09-28actual

Study start2026-10estimated (month precision)

Last update posted2026-10-08actual

Primary completion2028-07estimated (month precision)

Study completion2028-07estimated (month precision)

Assets

Drug assets

LY4560736

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 A1D-MC-ATMP screening protocol before entry into the treatment study.

•To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.

•To qualify as Chinese for this study, all four of the participant's biological grandparents must be of exclusive Chinese descent and born in China

Exclusion criteria

•Have a condition that predisposes the participant to an infection.

•Have a current or recent acute, active infection.

•Have active tuberculosis (TB), have or have had latent TB.

•Are receiving therapeutic antibodies or expected to initiate treatment with therapeutic antibodies during the study.

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

Amyloid biomarkers

Fluid / digital biomarkers

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 (13 Weeks)

change from baseline, improvement

Fluid / digital biomarkers

1 endpoint

Secondary/protocol endpoint

Concentration of LY4560736 in Cerebrospinal Fluid (CSF) in Healthy Participants

Time frame:Baseline through Study Completion (13 Weeks)

concentration, descriptive

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 13 Weeks

event count, event

Secondary/protocol endpoint

Pharmacokinetics (PK): Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUC0-∞) Following a Single Dose of LY4560736 in Healthy Participants

Time frame:Baseline, Week 5

concentration, descriptive

Secondary/protocol endpoint

PK: Plasma LY4560736 Maximum Concentration at Steady State (Cmax,ss) in Participants with AD

Time frame:Baseline through Week 13

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.