A Study of LY3439539 in Participants With Alzheimer's Disease

ClinicalTrials.gov ID

NCT07598370

Lead Sponsor

Eli Lilly and CompanyINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 1

Enrollment

30Estimated

Last Update Posted

Sep 4, 2026Actual

Start Date

May 21, 2026Actual

Primary Completion Date

Aug 2027Estimated

Completion Date

Aug 2027Estimated

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

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.

• Alzheimer Disease

• LY3439539

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Primary Purpose

Basic Science

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Eli Lilly and CompanyINDUSTRY

407-337-1000

+61 482 130 622

+612 8566 1500

0437 498 365

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