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

NCT07843459 | Not Yet Recruiting Phase 1 FDA Drug

• 3 other identifiers: 27911A1D-MC-AT02A1D-MC-ATMP
• Study Type: interventional
• Target: 111
• Locations: 3 countries
• Sites: 16

Brief 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.

Conditions

Healthy Volunteers; Alzheimer Disease; Amyloid; Plaque, Amyloid; Plasma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

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

  Baseline, Week 5

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

  Baseline through Week 13

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

  Baseline through Study Completion (13 Weeks)

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

  Baseline through Study Completion (13 Weeks)

Study Arms (4)

LY4560736 Part A: Single-Ascending Dose (SAD)

EXPERIMENTAL

LY4560736 administered intravenously (IV) or subcutaneously (SC) in healthy volunteers.

Drug: LY4560736

Placebo Part A

PLACEBO COMPARATOR

Placebo administered IV or SC in healthy volunteers.

Drug: Placebo

LY4560736 Part B: Multiple Ascending Dose (MAD)

EXPERIMENTAL

LY4560736 administered IV to participants with AD. Florbetapir F 18 or Florbetaben F 18 will be administered IV during amyloid positron emission tomography (PET) scan.

Drug: LY4560736; Other: Florbetapir F18; Other: Florbetaben F 18

Placebo Part B

PLACEBO COMPARATOR

Placebo administered IV to participants with AD. Florbetapir F 18 or Florbetaben F 18 will be administered IV during amyloid PET scan.

Drug: Placebo; Other: Florbetapir F18; Other: Florbetaben F 18

Interventions

LY4560736 DRUG

Administered intravenously (IV)

LY4560736 Part A: Single-Ascending Dose (SAD); LY4560736 Part B: Multiple Ascending Dose (MAD)

Placebo DRUG

Administered IV

Placebo Part A; Placebo Part B

Florbetapir F18 OTHER

Administered IV

LY4560736 Part B: Multiple Ascending Dose (MAD); Placebo Part B

Florbetaben F 18 OTHER

Administered IV

LY4560736 Part B: Multiple Ascending Dose (MAD); Placebo Part B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (16)

CenExel ACT

Anaheim, California, 92801, United States

Location

Irvine Clinical Research

Irvine, California, 92614, United States

Location

Collaborative Neuroscience Network - CNS

Los Alamitos, California, 90720, United States

Location

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

K2 Medical Research - The Villages

Lady Lake, Florida, 32159, United States

Location

K2 Medical Research

Maitland, Florida, 32751, United States

Location

Charter Research

Orlando, Florida, 32803, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Alzheimer's Research and Treatment Center

Stuart, Florida, 34996, United States

Location

K2 Medical Research - Tampa

Tampa, Florida, 33634, United States

Location

Charter Research

The Villages, Florida, 32162-2698, United States

Location

Accel Research Sites - NeuroStudies Clinical Research Unit

Decatur, Georgia, 30030, United States

Location

QUEST Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Xuanwu Hospital Capital Medical University

Beijing, 100053, China

Location

The University of Tokyo Hospital

Bunkyō City, 113-8655, Japan

Location

National Center for Geriatrics and Gerontology

Ōbu, 4748511, Japan

Location

MeSH Terms

Conditions

Alzheimer Disease; Plaque, Amyloid

Interventions

florbetapir; 4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 28, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (13); CN (1); JP (2)