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

Lilly

Status and phase: Not yet enrolling; Phase 1

Conditions: Plaque, Amyloid; Amyloid; Alzheimer Disease; Healthy Volunteers

Treatments: Drug: LY4405094; Drug: Placebo; Other: Florbetapir F18; Other: Florbetaben F 18

Study type: Interventional

Funder types: Industry

Identifiers

NCT07787182

27910

A1D-MC-AT01 (Other Identifier)

2026-527295-81-00 (EU Trial (CTIS) Number)

A1D-MC-ATMP (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 68 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 4 patient groups, including a placebo group

LY4405094 Part A: Single-Ascending Dose (SAD)

Experimental group

Description:

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

Treatment:

Drug: LY4405094

Drug: LY4405094

Placebo Part A

Placebo Comparator group

Description:

Placebo administered IV or SC in healthy volunteers.

Treatment:

Drug: Placebo

Drug: Placebo

LY4405094 Part B: Multiple Ascending Dose (MAD)

Experimental group

Description:

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.

Treatment:

Other: Florbetaben F 18

Drug: LY4405094

Other: Florbetapir F18

Drug: LY4405094

Placebo Part B

Placebo Comparator group

Description:

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.

Treatment:

Other: Florbetaben F 18

Other: Florbetapir F18

Drug: Placebo

Drug: Placebo