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NCT Number: NCT07598370

A Study of LY3439539 in Participants With 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.

Recruiting

Interested in participating?

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Key information

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Flinders Medical Centre, Adelaide, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY3439539

Drug

Administered IV

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)

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

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

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 20, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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