Recruiting
Phase 1

LY3439539

Sponsor:

Eli Lilly and Company

Code:

NCT07598370

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

LY3439539

Study Details

Brief 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.

Conditions

Alzheimer Disease

Study ID

NCT07598370

Start date

May 21, 2026

Status verified date

Nov, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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 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).

Exclusion Criteria:

  • 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
  • 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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: LY3439539

LY3439539 administered intravenously (IV)

Interventions

LY3439539

Administered IV

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) ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Irvine Clinical Research

Recruiting

Irvine, California, United States, 92614

Contacts

949-753-1663

Principal Investigator:

Elly Lee

Healthy Brain Clinic

Recruiting

Long Beach, California, United States, 90804

Contacts

562-606-5999

Principal Investigator:

Dung Trinh

Inglewood Clinical

Recruiting

Los Angeles, California, United States, 90056

Contacts

951-374-8000

Principal Investigator:

Maricor Grio

Oakland Clinical

Recruiting

Oakland, California, United States, 94609

Contacts

510-817-2000

Principal Investigator:

T. Richard Parenteau

K2 Medical Research

Recruiting

Maitland, Florida, United States, 32751

Contacts

407-500-5252

Principal Investigator:

Shelia Baez-Torres

QUEST Research Institute

Recruiting

Farmington Hills, Michigan, United States, 48334

Contacts

248-957-8940

Principal Investigator:

Aaron Ellenbogen

More Information

Sponsor

Eli Lilly and Company

Last update posted

Nov 4, 2026

Last verified

Nov, 2026

Keywords

  • Cognitive Impairment
  • Neurodegenerative Diseases
  • Dementia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-05. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-11-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.