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Not yet recruitingNCT07843459Updated Sep 28, 2026

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

A Phase 1 interventional study of LY4560736 and LY4560736 in Healthy Volunteers, Alzheimer Disease and Amyloid, sponsored by Eli Lilly and Company. Not yet recruiting at 16 sites in 3 countries. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
111
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

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.

02

Conditions studied

  • Healthy Volunteers
  • Alzheimer Disease
  • Amyloid
  • Plaque, Amyloid
  • Plasma
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
111 participants (estimated)

Study arms

  • Experimental
    LY4560736 Part A: Single-Ascending Dose (SAD)

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

    Drug: LY4560736

  • Placebo comparator
    Placebo Part A

    Placebo administered IV or SC in healthy volunteers.

    Drug: Placebo

  • Experimental
    LY4560736 Part B: Multiple Ascending Dose (MAD)

    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 comparator
    Placebo Part B

    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

  • DrugLY4560736

    Administered intravenously (IV)

  • DrugLY4560736

    Administered subcutaneously (SC)

  • DrugPlacebo

    Administered IV

  • DrugPlacebo

    Administered SC

  • OtherFlorbetapir F18

    Administered IV

  • OtherFlorbetaben F 18

    Administered IV

05

What researchers measure

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

    Time frame: Baseline up to 13 Weeks

Secondary outcomes

  1. 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

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

    Time frame: Baseline through Week 13

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

    Time frame: Baseline through Study Completion (13 Weeks)

  4. 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)

06

Study locations

16 sites
  • CenExel ACT
    Anaheim, California 92801, United States
    • · Contact · 714-774-7777
    • Amina Haggag · Principal investigator
  • Irvine Clinical Research
    Irvine, California 92614, United States
    • · Contact · 949-753-1663
    • Elly Lee · Principal investigator
  • Collaborative Neuroscience Network - CNS
    Los Alamitos, California 90720, United States
    • · Contact · 714-799-7799
    • Steven Reynolds · Principal investigator
  • Fortrea Clinical Research Unit
    Daytona Beach, Florida 32117, United States
    • · Contact · 386-366-6400
    • Chiamaka Iheme · Principal investigator
  • K2 Medical Research - The Villages
    Lady Lake, Florida 32159, United States
    • · Contact · 321-278-5590
    • Craig Curtis · Principal investigator
  • K2 Medical Research
    Maitland, Florida 32751, United States
    • · Contact · 407-232-9262
    • Brandon Lenox · Principal investigator
  • Charter Research
    Orlando, Florida 32803, United States
    • · Contact · 407-337-1000
    • Diana Balsalobre · Principal investigator
  • Progressive Medical Research
    Port Orange, Florida 32127, United States
    • · Contact · 386-304-7070
    • Alexander White · Principal investigator
  • Alzheimer's Research and Treatment Center
    Stuart, Florida 34996, United States
    • · Contact · 772-675-0000
    • Adam Falchook · Principal investigator
  • K2 Medical Research - Tampa
    Tampa, Florida 33634, United States
    • · Contact · 813-800-5252
    • Kelley Wilson · Principal investigator
  • Charter Research
    The Villages, Florida 32162-2698, United States
    • · Contact · 352-775-1000
    • Jeffrey Norton · Principal investigator
  • Accel Research Sites - NeuroStudies Clinical Research Unit
    Decatur, Georgia 30030, United States
    • · Contact · 404-475-0552
    • Marshall Nash · Principal investigator
  • QUEST Research Institute
    Farmington Hills, Michigan 48334, United States
    • · Contact · 248-957-8940
    • Aaron Ellenbogen · Principal investigator
  • Xuanwu Hospital Capital Medical University
    Beijing, 100053, China
    • Cuibai Wei · Principal investigator
  • The University of Tokyo Hospital
    Bunkyō City, 113-8655, Japan
    • · Contact · 81120023812
    • Yoshiki Niimi · Principal investigator
  • National Center for Geriatrics and Gerontology
    Ōbu, 4748511, Japan
    • · Contact · 81120023812
    • Keisuke Suzuki · Principal investigator
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07843459
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Sep 28, 2026
Start date
Oct 2026 (estimated)
Primary completion
Jul 2028 (estimated)
Completion
Jul 2028 (estimated)
Last update
Sep 28, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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