Recruiting
Phase 1

LY4405094

Sponsor:

Eli Lilly and Company

Code:

NCT07787182

Conditions

Healthy Volunteers

Alzheimer Disease

Amyloid

Plaque, Amyloid

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

LY4405094

LY4405094

Placebo

Placebo

Florbetapir F18

Study Details

Brief summary:

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.

Conditions

Healthy Volunteers

Alzheimer Disease

Amyloid

Plaque, Amyloid

Study ID

NCT07787182

Start date

Oct 14, 2025

Status verified date

Oct, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

68 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: LY4405094 Part A: Single-Ascending Dose (SAD)

LY4405094 administered intravenously (IV) or subcutaneously (SC) in healthy volunteers.

placebo comparator: Placebo Part A

Placebo administered IV or SC in healthy volunteers.

experimental: LY4405094 Part B: Multiple Ascending Dose (MAD)

LY4405094 administered IV to participants with AD. Florbetapir F 18 or Florbetaben F 18 will be administered IV during amyloid positron emission tomography (PET) scan.

placebo comparator: Placebo Part B

Placebo administered IV to participants with AD. Florbetapir F 18 or Florbetaben F 18 will be administered IV during amyloid positron emission tomography (PET) scan.

Interventions

LY4405094

Administered intravenously (IV)

LY4405094

Administered Subcutaneously (SC)

Placebo

Administered IV

Placebo

Administered SC

Florbetapir F18

Administered IV

Florbetaben F 18

Administered IV

Primary outcome measure

  • 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 ]

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

Fortrea Clinical Research Unit

Recruiting

Daytona Beach, Florida, United States, 32117

Contacts

386-366-6400

Principal Investigator:

Chiamaka Iheme

More Information

Sponsor

Eli Lilly and Company

Last update posted

Oct 22, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-10-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.