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Clinical Trials in Japan / NCT07843459
Starting soon Phase 1

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

NCT07843459 · tracked via the Priya Life Science Japan tracker
Sponsor
Eli Lilly and Company
Phase
Phase 1
Started
2026-10
Last updated
2026-10-08

Condition(s) studied

Healthy VolunteersAlzheimer DiseaseAmyloidPlaque, AmyloidPlasma

Investigational drug(s) / intervention(s)

LY4560736LY4560736PlaceboPlaceboFlorbetapir F18Florbetaben F 18

LY4560736: Administered intravenously (IV)

LY4560736: Administered subcutaneously (SC)

Placebo: Administered IV

Placebo: Administered SC

Florbetapir F18: Administered IV

Florbetaben F 18: Administered IV

Study summary

The purpose of this study is to see how safe LY4560736 is and to see how much and how quickly LY4560736 gets into the bloodstream. For healthy participants, the study also looks at how much LY4560736 gets into the brain. This part of the study lasts up to 13 weeks which includes staying in the Clinical Research Unit (CRU) for at least 4 days. This group will include Japanese participants, and the Sponsor may choose to enroll Chinese participants. For participants with Alzheimer's Disease, the study will also look at levels of a specific Alzheimer's-related protein in the brain and will last up to 13 weeks which includes staying in the CRU twice, each lasts about 1 to 2 days. Japanese participants, and potentially Chinese participants, may also be enrolled in this group.

Eligibility

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • 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 13 Weeks

Trial sites (18)

FacilityCityRegionStatus
CenExel ACT Anaheim California
Irvine Clinical Research Irvine California
Collaborative Neuroscience Network - CNS Los Alamitos California
Fortrea Clinical Research Unit Daytona Beach Florida
K2 Medical Research - The Villages Lady Lake Florida
K2 Medical Research Maitland Florida
Charter Research Orlando Florida
Progressive Medical Research Port Orange Florida
Alzheimer's Research and Treatment Center Stuart Florida
K2 Medical Research - Tampa Tampa Florida
Charter Research The Villages Florida
Accel Research Sites - NeuroStudies Clinical Research Unit Decatur Georgia
QUEST Research Institute Farmington Hills Michigan
Xuanwu Hospital Capital Medical University Beijing China
Huashan Hospital, Fudan University Minhang District China
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai China
The University of Tokyo Hospital Bunkyō City Japan
National Center for Geriatrics and Gerontology Ōbu Japan

More Eli Lilly and Company trials in Japan

A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3) Active, not recruiting
A Study of LY4006896 in Healthy Participants and Participants With Parkinson's Disease Recruiting
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors Active, not recruiting
A Study of Brenipatide in Adults Who Quit Smoking Cigarettes and Want to Avoid Relapse Recruiting
MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors Active, not recruiting

Other trials for the same condition

A Master Protocol Studying Multiple Amyloid-Targeting Therapies in Healthy Participants and Participants With Alzheimer's Disease Recruiting
A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5) Recruiting
A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7) Recruiting
A Study of Donanemab (LY3002813) in Participants Who Completed Study AACM (TRAILBLAZER-ALZ 3-EXT). Recruiting
Epidemiology and Biomarker Study in Alzheimer's Disease Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07843459 on ClinicalTrials.gov ↗ ← All trials in Japan