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

Conditions

• Alzheimer Disease
• Amyloid
• Healthy Volunteers
• Plaque, Amyloid

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Accepted

Interventions

• LY4405094 — DRUG
  Administered intravenously (IV)
• LY4405094 — DRUG
  Administered Subcutaneously (SC)
• Placebo — DRUG
  Administered IV
• Placebo — DRUG
  Administered SC
• Florbetapir F18 — OTHER
  Administered IV
• Florbetaben F 18 — OTHER
  Administered IV

Study Details

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.

Key Dates

First listed

Aug 26, 2026

Start date

Sep 30, 2026

Status verified

Aug 2026

Primary completion

Jan 31, 2028

Completion

Jan 31, 2028

Study Design

Enrollment

68 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

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

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  1-317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  [email protected]

Locations (10)

Find similar trials in Irvine, CA

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