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Not yet recruitingNCT07843459Updated Oct 8, 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 18 sites in 3 countries. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-08.

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

Updated Oct 8, 2026Newly registered2 sites addedGo to Updates ↓

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

Where this study stands

Counted across the records on this site · 2026-11-15

Among 99 studies in Alzheimer Disease by Eli Lilly and Company — 13 open to participants now, 19 under way, 8 of them phase 3. Alzheimer Disease · Eli Lilly and Company.

Planned enrollment
44th of 95
111 · median 95
Started
2026
with 7 others
Phase 1
34 of 99
6 open now
Primary completion
2028-07
later than 9 of 18 live
Registered
99th of 99
by date

Among the 99 studies in Alzheimer Disease by Eli Lilly and Company, this one is the 44th largest by planned enrollment of the 95 interventional ones that give a count, is one of 8 that started in 2026, is one of 34 in phase 1, reaches primary completion later than 9 of the 18 other live ones, and was the 99th registered.

Alzheimer Disease

3,968 studies on the registry are indexed under Alzheimer Disease; 928 are open to participants now.

Browse Alzheimer Disease studies →

Open to participants now

13 of the 99 studies in Alzheimer Disease by Eli Lilly and Company are open now, in 11 countries. Recruiting first, the newest first:

7 more — sign in →

By country, each count listing its studies:

All 13 open studies →

Who these studies take

Of the 643 Alzheimer Disease studies recruiting now, 284 (44%) set no upper age limit and 55 (9%) stop at 75 or younger; 34 take children under 18; 285 take healthy volunteers.

This study: 18 Years to 85 Years · all sexes · healthy volunteers too.

The full table on the hub →

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02

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.

03

Conditions studied

  • Healthy Volunteers
  • Alzheimer Disease
  • Amyloid
  • Plaque, Amyloid
  • Plasma
04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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.
05

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

06

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)

07

Study locations

18 sites
  • CenExel ACT
    Anaheim, California 92801, United States
    • · Contact714-774-7777
    • Amina Haggag · Principal investigator
  • Irvine Clinical Research
    Irvine, California 92614, United States
    • · Contact949-753-1663
    • Elly Lee · Principal investigator
  • Collaborative Neuroscience Network - CNS
    Los Alamitos, California 90720, United States
    • · Contact714-799-7799
    • Steven Reynolds · Principal investigator
  • Fortrea Clinical Research Unit
    Daytona Beach, Florida 32117, United States
    • · Contact386-366-6400
    • Chiamaka Iheme · Principal investigator
  • K2 Medical Research - The Villages
    Lady Lake, Florida 32159, United States
    • · Contact321-278-5590
    • Craig Curtis · Principal investigator
  • K2 Medical Research
    Maitland, Florida 32751, United States
    • · Contact407-232-9262
    • Brandon Lenox · Principal investigator
  • Charter Research
    Orlando, Florida 32803, United States
    • · Contact407-337-1000
    • Diana Balsalobre · Principal investigator
  • Progressive Medical Research
    Port Orange, Florida 32127, United States
    • · Contact386-304-7070
    • Alexander White · Principal investigator
  • Alzheimer's Research and Treatment Center
    Stuart, Florida 34996, United States
    • · Contact772-675-0000
    • Adam Falchook · Principal investigator
  • K2 Medical Research - Tampa
    Tampa, Florida 33634, United States
    • · Contact813-800-5252
    • Kelley Wilson · Principal investigator
  • Charter Research
    The Villages, Florida 32162-2698, United States
    • · Contact352-775-1000
    • Jeffrey Norton · Principal investigator
  • Accel Research Sites - NeuroStudies Clinical Research Unit
    Decatur, Georgia 30030, United States
    • · Contact404-475-0552
    • Marshall Nash · Principal investigator
  • QUEST Research Institute
    Farmington Hills, Michigan 48334, United States
    • · Contact248-957-8940
    • Aaron Ellenbogen · Principal investigator
  • Xuanwu Hospital Capital Medical University
    Beijing, 100053, China
    • Cuibai Wei · Principal investigator
  • Huashan Hospital, Fudan University
    Minhang District, 201107, China
    • · Contact021-54601999
    • Jintai Yu · Principal investigator
  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
    Shanghai, 200127, China
    • Gang Wang · Principal investigator
  • The University of Tokyo Hospital
    Bunkyō City, 113-8655, Japan
    • · Contact81120023812
    • Yoshiki Niimi · Principal investigator
  • National Center for Geriatrics and Gerontology
    Ōbu, 4748511, Japan
    • · Contact81120023812
    • Keisuke Suzuki · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Jul 2028, 21 months later.

Of 161 industry-sponsored phase 1 interventional studies under Alzheimer Disease, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 23. This study's planned 21 months is above that.

Counting every sponsor, half of 234 studies reached it within 18 months; a quarter within 7 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 22, 2026
First posted
Sep 28, 2026
StartEst.
Oct 2026
Primary completionEst.
Jul 2028
CompletionEst.
Jul 2028
Last update
Oct 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
2 sites added
Show 2 added (2 China)
  • Huashan Hospital, Fudan University · Minhang District, China
  • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine · Shanghai, China
Oct 8, 2026
Registered
First appeared on the registry
Sep 28, 2026
Show all 2 updates
  1. Oct 8, 2026
    2 sites added
    Show 2 added (2 China)
    • Huashan Hospital, Fudan University · Minhang District, China
    • Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine · Shanghai, China
    + 1 other change: verification date
  2. Sep 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07843459
Responsible party
Sponsor
First posted
Sep 28, 2026
Start date
Oct 2026 (estimated)
Primary completion
Jul 2028 (estimated)
Completion
Jul 2028 (estimated)
Last update
Oct 8, 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 ↗

Not currently enrolling

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

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