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NCT Number: NCT07787182

A Study of LY4405094 in Healthy Participants and Participants With Alzheimer's Disease

The purpose of this study is to see how safe LY4405094 is and to see how much and how quickly LY4405094 gets into the bloodstream. For healthy participants, the study also looks at how much LY4405094 gets into the fluid around the brain and lasts up to 13 weeks and will include a 4-day stay in the Clinical Research Unit (CRU). For participants with Alzheimer's Disease, the study will also look at levels of a specific Alzheimer's-related protein in the brain and will last up to 25 weeks and will include a 3-day stay in the CRU.

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Key information

Conditions

Healthy Volunteers Alzheimer Disease Amyloid Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Amyloid Tauopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Irvine Clinical Research, Irvine, California, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants must meet eligibility criteria in the ATMP screening protocol before entry into the treatment study.

Exclusion criteria

  • Have known allergies to LY4405094, related compounds (including remternetug), or any components of the formulation, including LY4405094.
  • Have known allergic reactions to adhesive or hydrogels or a family history of adhesive skin allergies.

Treatment and study plan

LY4405094

Drug

Administered intravenously (IV)

Placebo

Drug

Administered IV

Florbetapir F18

Other

Administered IV

Florbetaben F 18

Other

Administered IV

Primary outcomes

  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: Baseline up to 25 Weeks

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4405094 in Healthy Participants

    Time frame: Baseline through Study Completion (Week 13)

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY4405094 in Participants with Alzheimer's Disease (AD)

    Time frame: Baseline through Study Completion (25 Weeks)

  3. Change from Baseline of Cerebrospinal Fluid (CSF) Concentration of LY4405094 in Healthy Participants

    Time frame: Baseline through Study Completion (Week 13)

  4. Change from Baseline of Amyloid Plaque levels as Assessed by Amyloid Positron Emission Tomography (PET) in Participants with AD

    Time frame: Baseline through Study Completion (25 Weeks)

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 Placebo-Controlled, Single- and Multiple-Ascending Dose, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4405094 in Healthy Participants and Participants With Alzheimer's Disease

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 26, 2026
Registry last updated
Aug 26, 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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