Alzheimer DiseasePhase 1NCT07598370
A Study of LY3439539 in Participants With Alzheimer's Disease
A Phase 1 study testing LY3439539 in people with Alzheimer Disease, run by Eli Lilly and Company at 16 sites in 4 countries.
Trial summary
The purpose of this study is to see how LY3439539 affects certain proteins found in the spinal fluid of participants with Alzheimer's disease. Participation in the study will last approximately 9 months with visits about once a month. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- LY3439539
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 16 sitesin 4 countries
- Study dates
- 21 May 2026to Aug 2027
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have gradual and progressive change in memory function reported by the participant or informant for 6 months or longer consistent with a diagnosis of dementia due to Alzheimer's disease
- Have a Mini Mental Score Examination score of 16 to 24, inclusive
- Meet plasma pTau criteria, as defined by the sponsor
- Have body mass index within the range of 17 and 32 kilograms per square meter (kg/m²) (inclusive) at screening
- Are women not of childbearing potential and men willing to practice effective contraception throughout the study.
- Have adequate premorbid literacy, vision, and hearing throughout the study duration and able to complete study procedures.
- Have at least 1, and up to 2, study partners who are in frequent contact with the participant (defined as at least 10 hours per week).
Who cannot join
- Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
- Have a screening MRI that shows evidence of significant abnormality.
- Have history of suicidal behavior, or a lifetime history of suicide attempt or acute suicidality.
- Have a history of
- Severe or ongoing allergy or hypersensitivity reactions
- Hypersensitivity to immunizations or immunoglobulins
Show all 13Show fewer
- Two or more clinically significant or severe drug allergies,
- Intolerance to topical corticosteroids or severe posttreatment hypersensitivity reactions
- Have current serious or unstable illnesses, including hepatic, renal, gastroenterological, respiratory, cardiovascular, neurologic (other than AD), psychiatric, endocrinologic, immunologic, hematologic disease, or other conditions
- Require treatment with another monoclonal antibody or have received treatment with biologic agents (such as monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
- Have criteria that would preclude a lumbar puncture (LP).
- Are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study.
- Have a current exposure to amyloid-targeting therapies (ATTs). Prior exposure to ATTs greater than 1 year from the last dose may be permitted at the discretion of the investigator and in consultation with the sponsor.
Trial locations and contacts
16 sites in 4 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
16 sites in 4 countries
United States9 sites, 9 recruiting
- Recruiting
QUEST Research Institute
Farmington Hills, Michigan, 48334
248-957-8940
Aaron Ellenbogen
- Recruiting
Irvine Clinical Research
Irvine, California, 92614
949-753-1663
Elly Lee
- Not yet recruiting
K2 Medical Research - The Villages
Lady Lake, Florida, 32159
352-500-5252
Craig Curtis
- Recruiting
Healthy Brain Clinic
Long Beach, California, 90804
562-606-5999
Dung Trinh
- Recruiting
Inglewood Clinical
Los Angeles, California, 90056
951-374-8000
Maricor Grio
- Recruiting
K2 Medical Research
Maitland, Florida, 32751
407-500-5252
Shelia Baez-Torres
- Recruiting
Oakland Clinical
Oakland, California, 94609
510-817-2000
T. Richard Parenteau
- Not yet recruiting
Charter Research
Orlando, Florida, 32803
407-337-1000
Diana Balsalobre
- Not yet recruiting
AdventHealth Orlando
Orlando, Florida, 32804
407-609-9040
Daniel Okobi
Australia5 sites, 5 recruiting
- Not yet recruiting
Flinders Medical Centre
Adelaide, 5042
+61 482 130 622
Lauren Priest
- Recruiting
Austin Health - Heidelberg Repatriation Hospital
Ivanhoe, 3079
+613 9496 2388
Paul Yates
- Recruiting
Southern Neurology
Kogarah, 2217
+612 8566 1500
Raymond Schwartz
- Recruiting
Macquarie University Hospital
Macquarie University, 2109
0298122956
James Burrell
- Recruiting
The Alfred
Melbourne, 3004
0437 498 365
David Darby
New Zealand1 site, 1 recruiting
- Not yet recruiting
Christchurch Neurology Trials
Christchurch, 8011
+ 64 33786662
Timothy Anderson
Singapore1 site, 1 recruiting
- Recruiting
Lilly Centre for Clinical Pharmacology
Singapore, 138623
+65 6413 9811
Jeffer Hann Wei Pang
About this study
Official title: A Phase 1, Open Label, Multiple-Dose Study to Assess the Changes in Cerebrospinal Fluid Biomarkers for Alzheimer's Disease Following Treatment With LY3439539 in Participants With Symptomatic Alzheimer's Disease
The purpose of this study is to see how LY3439539 affects certain proteins found in the spinal fluid of participants with Alzheimer's disease.
Participation in the study will last approximately 9 months with visits about once a month.
- Conditions
- Alzheimer Disease
- Being tested
- LY3439539
- Keywords
- Cognitive Impairment, Neurodegenerative Diseases, Dementia
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Neurodegenerative Diseases, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3439539Drug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| LY3439539 | Experimental | LY3439539 administered intravenously (IV) Receives: Drug: LY3439539 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Cerebrospinal Fluid (CSF) Neurofilament Light Chain (NfL)
Measured: Baseline through end of the Follow-up Period (Week 24)
Secondary outcomes (4)
Change from Baseline in Phospho-Tau (pTau)
Measured: Baseline through end of the Follow-up Period (Week 24)
Change from Baseline in Plasma NfL
Measured: Baseline through end of the Follow-up Period (Week 24)
Pharmacokinetics (PK) Maximum LY3439539 Serum Concentration (Cmax)
Measured: Baseline through end of the Follow-up Period (Week 24)
PK: Minimum LY3439539 Serum Concentration (Cmin)
Measured: Time Frame: Baseline through end of Follow up Period (Week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start21 May 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT07598370
- Sponsor's protocol ID
- 18818
- Other IDs
- I9M-MC-ONAA
- Status last verified
- Nov 2026
- First submitted
- 14 May 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open Label, Multiple-Dose Study to Assess the Changes in Cerebrospinal Fluid Biomarkers for Alzheimer's Disease Following Treatment With LY3439539 in Participants With Symptomatic Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07598370
- Acronym / sponsor ID
- 18818
- Conditions
- Alzheimer Disease
- Keywords
- Cognitive Impairment, Neurodegenerative Diseases, Dementia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 21 May 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 20 May 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 LY3439539 affects certain proteins found in the spinal fluid of participants with Alzheimer's disease.
Participation in the study will last approximately 9 months with visits about once a month.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY3439539 | Experimental | Drug: LY3439539LY3439539 administered intravenously (IV) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have gradual and progressive change in memory function reported by the participant or informant for 6 months or longer consistent with a diagnosis of dementia due to Alzheimer's disease
- Have a Mini Mental Score Examination score of 16 to 24, inclusive
- Meet plasma pTau criteria, as defined by the sponsor
- Have body mass index within the range of 17 and 32 kilograms per square meter (kg/m²) (inclusive) at screening
- Are women not of childbearing potential and men willing to practice effective contraception throughout the study.
Key exclusion criteria (13 listed)
- Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
- Have a screening MRI that shows evidence of significant abnormality.
- Have history of suicidal behavior, or a lifetime history of suicide attempt or acute suicidality.
- Have a history of
- Have current serious or unstable illnesses, including hepatic, renal, gastroenterological, respiratory, cardiovascular, neurologic (other than AD), psychiatric, endocrinologic, immunologic, hematologic disease, or other conditions
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 |
|---|---|---|
| LY3439539Administered IV | Drug | LY3439539 |
Primary outcome
Change from Baseline in Cerebrospinal Fluid (CSF) Neurofilament Light Chain (NfL)
Time frame: Baseline through end of the Follow-up Period (Week 24)
4 secondary outcomes
Change from Baseline in Phospho-Tau (pTau)
Time frame: Baseline through end of the Follow-up Period (Week 24)
Change from Baseline in Plasma NfL
Time frame: Baseline through end of the Follow-up Period (Week 24)
Pharmacokinetics (PK) Maximum LY3439539 Serum Concentration (Cmax)
Time frame: Baseline through end of the Follow-up Period (Week 24)
PK: Minimum LY3439539 Serum Concentration (Cmin)
Time frame: Time Frame: Baseline through end of Follow up Period (Week 24)
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 4 Nov 2026.
- Individual participant dataSharing planned: No
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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
16 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3439539 in people with Alzheimer Disease, run by Eli Lilly and Company at 16 sites in 4 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 7 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Australia, New Zealand, Singapore. 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. 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?
Change from Baseline in Cerebrospinal Fluid (CSF) Neurofilament Light Chain (NfL) (time frame: Baseline through end of the Follow-up Period (Week 24)). 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 4 Nov 2026.