Healthy VolunteersPhase 1NCT07843459
A Study of LY4560736 in Healthy Participants and Participants With Alzheimer's Disease (AD)
A Phase 1 study testing LY4560736, Florbetapir F18 and Florbetaben F 18 in people with Healthy Volunteers and Alzheimer Disease, run by Eli Lilly and Company at 18 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Alzheimer Disease, Amyloid
- What is being tested?
- LY4560736, Florbetapir F18 and Florbetaben F 18
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 18 sitesin 3 countries
- Study dates
- Oct 2026to Jul 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
18 sites in 3 countries
United States13 sites
CenExel ACT
Anaheim, California, 92801
714-774-7777
Amina Haggag
Fortrea Clinical Research Unit
Daytona Beach, Florida, 32117
386-366-6400
Chiamaka Iheme
Accel Research Sites - NeuroStudies Clinical Research Unit
Decatur, Georgia, 30030
404-475-0552
Marshall Nash
QUEST Research Institute
Farmington Hills, Michigan, 48334
248-957-8940
Aaron Ellenbogen
Irvine Clinical Research
Irvine, California, 92614
949-753-1663
Elly Lee
K2 Medical Research - The Villages
Lady Lake, Florida, 32159
321-278-5590
Craig Curtis
Collaborative Neuroscience Network - CNS
Los Alamitos, California, 90720
714-799-7799
Steven Reynolds
K2 Medical Research
Maitland, Florida, 32751
407-232-9262
Brandon Lenox
Charter Research
Orlando, Florida, 32803
407-337-1000
Diana Balsalobre
Progressive Medical Research
Port Orange, Florida, 32127
386-304-7070
Alexander White
Alzheimer's Research and Treatment Center
Stuart, Florida, 34996
772-675-0000
Adam Falchook
K2 Medical Research - Tampa
Tampa, Florida, 33634
813-800-5252
Kelley Wilson
Charter Research
The Villages, Florida, 32162-2698
352-775-1000
Jeffrey Norton
China3 sites
Xuanwu Hospital Capital Medical University
Beijing, 100053
Cuibai Wei
Huashan Hospital, Fudan University
Minhang District, 201107
021-54601999
Jintai Yu
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, 200127
Gang Wang
Japan2 sites
The University of Tokyo Hospital
Bunkyō City, 113-8655
81120023812
Yoshiki Niimi
National Center for Geriatrics and Gerontology
Ōbu, 4748511
81120023812
Keisuke Suzuki
About this study
Official title: 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
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
- Being tested
- LY4560736, Placebo, Florbetapir F18, Florbetaben F 18
- Medical subject headings
- Alzheimer Disease, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4560736Drug
Administered intravenously (IV)
LY4560736Drug
Administered subcutaneously (SC)
PlaceboDrug
Administered IV
PlaceboDrug
Administered SC
Florbetapir F18Other
Administered IV
Florbetaben F 18Other
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| LY4560736 Part A: Single-Ascending Dose (SAD) | Experimental | LY4560736 administered intravenously (IV) or subcutaneously (SC) in healthy volunteers. Receives: Drug: LY4560736 |
| Placebo Part A | Placebo comparator | Placebo administered IV or SC in healthy volunteers. Receives: 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. Receives: 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. Receives: Drug: Placebo; Other: Florbetapir F18; Other: Florbetaben F 18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Measured: 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
Measured: Baseline, Week 5
PK: Plasma LY4560736 Maximum Concentration at Steady State (Cmax,ss) in Participants with AD
Measured: Baseline through Week 13
Concentration of LY4560736 in Cerebrospinal Fluid (CSF) in Healthy Participants
Measured: 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
Measured: Baseline through Study Completion (13 Weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07843459
- Sponsor's protocol ID
- 27911
- Other IDs
- A1D-MC-AT02, A1D-MC-ATMP
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07843459
- Acronym / sponsor ID
- 27911
- Conditions
- Healthy Volunteers, Alzheimer Disease, Amyloid, Plaque, Amyloid, Plasma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY4560736 Part A: Single-Ascending Dose (SAD) | Experimental | Drug: LY4560736LY4560736 administered intravenously (IV) or subcutaneously (SC) in healthy volunteers. |
| Placebo Part A | Placebo comparator | Drug: PlaceboPlacebo administered IV or SC in healthy volunteers. |
| LY4560736 Part B: Multiple Ascending Dose (MAD) | Experimental | Drug: LY4560736, Other: Florbetapir F18, Other: Florbetaben F 18LY4560736 administered IV to participants with AD. Florbetapir F 18 or Florbetaben F 18 will be administered IV during amyloid positron emission tomography (PET) scan. |
| Placebo Part B | Placebo comparator | Drug: Placebo, Other: Florbetapir F18, Other: Florbetaben F 18Placebo administered IV to participants with AD. Florbetapir F 18 or Florbetaben F 18 will be administered IV during amyloid PET scan. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY4560736Administered intravenously (IV) | Drug | LY4560736 Part A: Single-Ascending Dose (SAD), LY4560736 Part B: Multiple Ascending Dose (MAD) |
| LY4560736Administered subcutaneously (SC) | Drug | LY4560736 Part A: Single-Ascending Dose (SAD) |
| PlaceboAdministered IV | Drug | Placebo Part A, Placebo Part B |
| PlaceboAdministered SC | Drug | Placebo Part A |
| Florbetapir F18Administered IV | Other | LY4560736 Part B: Multiple Ascending Dose (MAD), Placebo Part B |
| Florbetaben F 18Administered IV | Other | LY4560736 Part B: Multiple Ascending Dose (MAD), Placebo Part B |
Primary outcome
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
4 secondary outcomes
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
PK: Plasma LY4560736 Maximum Concentration at Steady State (Cmax,ss) in Participants with AD
Time frame: Baseline through Week 13
Concentration of LY4560736 in Cerebrospinal Fluid (CSF) in Healthy Participants
Time frame: 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
Time frame: Baseline through Study Completion (13 Weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY4560736, Florbetapir F18 and Florbetaben F 18 in people with Healthy Volunteers and Alzheimer Disease, run by Eli Lilly and Company at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, China, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.