ClinicalTrials.gg
RecruitingNCT07598370Updated Nov 4, 2026

A Study of LY3439539 in Participants With Alzheimer's Disease

A Phase 1 interventional study of LY3439539 in Alzheimer Disease, sponsored by Eli Lilly and Company. Recruiting at 16 sites in 4 countries. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Updated Nov 4, 2026Site recruiting status changed1 site addedGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
50 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer Disease

Keywords

  • Cognitive Impairment
  • Neurodegenerative Diseases
  • Dementia
03

In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's planned enrollment of 30 is below the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.

Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

  • 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 within the range of 17 and 32 kilograms per square meter (kg/m²) (inclusive) at screening
  • Are women not of and men willing to practice effective 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).

Exclusion criteria

Exclusion Criteria:

  • Have any 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 reactions
    • Hypersensitivity to immunizations or immunoglobulins
    • Two or more or severe drug allergies,
    • Intolerance to topical 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 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.
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    LY3439539

    LY3439539 administered intravenously (IV)

    Drug: LY3439539

Interventions

  • DrugLY3439539

    Administered IV

06

What researchers measure

Primary outcomes

  1. Change from Baseline in Cerebrospinal Fluid (CSF) Neurofilament Light Chain (NfL)

    Time frame: Baseline through end of the Follow-up Period (Week 24)

Secondary outcomes

  1. Change from Baseline in Phospho-Tau (pTau)

    Time frame: Baseline through end of the Follow-up Period (Week 24)

  2. Change from Baseline in Plasma NfL

    Time frame: Baseline through end of the Follow-up Period (Week 24)

  3. Pharmacokinetics (PK) Maximum LY3439539 Serum Concentration (Cmax)

    Time frame: Baseline through end of the Follow-up Period (Week 24)

  4. PK: Minimum LY3439539 Serum Concentration (Cmin)

    Time frame: Time Frame: Baseline through end of Follow up Period (Week 24)

07

Study locations

11 of 16 sites recruiting
  • Irvine Clinical Research
    Irvine, California 92614, United States
    Recruiting
    • · Contact949-753-1663
    • Elly Lee · Principal investigator
  • Healthy Brain Clinic
    Long Beach, California 90804, United States
    Recruiting
    • · Contact562-606-5999
    • Dung Trinh · Principal investigator
  • Inglewood Clinical
    Los Angeles, California 90056, United States
    Recruiting
    • · Contact951-374-8000
    • Maricor Grio · Principal investigator
  • Oakland Clinical
    Oakland, California 94609, United States
    Recruiting
    • · Contact510-817-2000
    • T. Richard Parenteau · Principal investigator
  • K2 Medical Research - The Villages
    Lady Lake, Florida 32159, United States
    Not yet recruiting
    • · Contact352-500-5252
    • Craig Curtis · Principal investigator
  • K2 Medical Research
    Maitland, Florida 32751, United States
    Recruiting
    • · Contact407-500-5252
    • Shelia Baez-Torres · Principal investigator
  • Charter Research
    Orlando, Florida 32803, United States
    Not yet recruiting
    • · Contact407-337-1000
    • Diana Balsalobre · Principal investigator
  • AdventHealth Orlando
    Orlando, Florida 32804, United States
    Not yet recruiting
    • · Contact407-609-9040
    • Daniel Okobi · Principal investigator
  • QUEST Research Institute
    Farmington Hills, Michigan 48334, United States
    Recruiting
    • · Contact248-957-8940
    • Aaron Ellenbogen · Principal investigator
  • Flinders Medical Centre
    Adelaide, 5042, Australia
    Not yet recruiting
    • · Contact+61 482 130 622
    • Lauren Priest · Principal investigator
  • Austin Health - Heidelberg Repatriation Hospital
    Ivanhoe, 3079, Australia
    Recruiting
    • · Contact+613 9496 2388
    • Paul Yates · Principal investigator
  • Southern Neurology
    Kogarah, 2217, Australia
    Recruiting
    • · Contact+612 8566 1500
    • Raymond Schwartz · Principal investigator
  • Macquarie University Hospital
    Macquarie University, 2109, Australia
    Recruiting
    • · Contact0298122956
    • James Burrell · Principal investigator
  • The Alfred
    Melbourne, 3004, Australia
    Recruiting
    • · Contact0437 498 365
    • David Darby · Principal investigator
  • Christchurch Neurology Trials
    Christchurch, 8011, New Zealand
    Not yet recruiting
    • · Contact+ 64 33786662
    • Timothy Anderson · Principal investigator
  • Lilly Centre for Clinical Pharmacology
    Singapore, 138623, Singapore
    Recruiting
    • · Contact+65 6413 9811
    • Jeffer Hann Wei Pang · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sites
1 site added. 6 sites changed recruiting status (6 now recruiting)
Show 6 sites
  • Irvine Clinical Research · Irvine, United StatesNot yet recruiting→Recruiting
  • Healthy Brain Clinic · Long Beach, United StatesNot yet recruiting→Recruiting
  • Inglewood Clinical · Los Angeles, United StatesNot yet recruiting→Recruiting
  • Oakland Clinical · Oakland, United StatesNot yet recruiting→Recruiting
  • K2 Medical Research · Maitland, United StatesNot yet recruiting→Recruiting
  • QUEST Research Institute · Farmington Hills, United StatesNot yet recruiting→Recruiting
Show site
  • K2 Medical Research - The Villages · Lady Lake, United States
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    1 site added. 6 sites changed recruiting status (6 now recruiting)
    Show 6 sites
    • Irvine Clinical Research · Irvine, United StatesNot yet recruiting→Recruiting
    • Healthy Brain Clinic · Long Beach, United StatesNot yet recruiting→Recruiting
    • Inglewood Clinical · Los Angeles, United StatesNot yet recruiting→Recruiting
    • Oakland Clinical · Oakland, United StatesNot yet recruiting→Recruiting
    • K2 Medical Research · Maitland, United StatesNot yet recruiting→Recruiting
    • QUEST Research Institute · Farmington Hills, United StatesNot yet recruiting→Recruiting
    Show site
    • K2 Medical Research - The Villages · Lady Lake, United States
    + 1 other change: verification date

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
NCT07598370
Responsible party
Sponsor
First posted
May 20, 2026
Start date
May 21, 2026
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Nov 4, 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
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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