NCT07598370RecruitingPhase 1
A Study of LY3439539 in Participants With Alzheimer's Disease
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
Source: ClinicalTrials.gov · Last updated 4 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 14 May 2026
- Start date
- 21 May 2026
- Primary completion date
- 31 Aug 2027
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Alzheimer disease
- NCT number
- NCT07598370
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 30
- From 21 May 2026 to the primary completion date, 31 Aug 2027
- 16 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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.
Other illness
- Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
- 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
- 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
Other
- Have a screening MRI that shows evidence of significant abnormality.
- Have criteria that would preclude a lumbar puncture (LP).
Who the study is looking for
- 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).
Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Flinders Medical Centre Coordinator of this site? Confirm its status | Adelaide | Australia | Not yet recruiting |
| Austin Health - Heidelberg Repatriation Hospital Coordinator of this site? Confirm its status | Ivanhoe | Australia | Recruiting |
| Southern Neurology Coordinator of this site? Confirm its status | Kogarah | Australia | Recruiting |
| Macquarie University Hospital Coordinator of this site? Confirm its status | Macquarie University | Australia | Recruiting |
| The Alfred Coordinator of this site? Confirm its status | Melbourne | Australia | Recruiting |
| Christchurch Neurology Trials Coordinator of this site? Confirm its status | Christchurch | New Zealand | Not yet recruiting |
| Lilly Centre for Clinical Pharmacology Coordinator of this site? Confirm its status | Singapore | Singapore | Recruiting |
| QUEST Research Institute Coordinator of this site? Confirm its status | Farmington Hills | United States | Not yet recruiting |
| Irvine Clinical Research Coordinator of this site? Confirm its status | Irvine | United States | Not yet recruiting |
| Healthy Brain Clinic Coordinator of this site? Confirm its status | Long Beach | United States | Not yet recruiting |
| Inglewood Clinical Coordinator of this site? Confirm its status | Los Angeles | United States | Not yet recruiting |
| K2 Medical Research Coordinator of this site? Confirm its status | Maitland | United States | Not yet recruiting |
| Oakland Clinical Coordinator of this site? Confirm its status | Oakland | United States | Not yet recruiting |
| Charter Research Coordinator of this site? Confirm its status | Orlando | United States | Not yet recruiting |
| AdventHealth Orlando Coordinator of this site? Confirm its status | Orlando | United States | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.