A Study of LY4560736 in Healthy Participants and Participants With Alzheimer's Disease (AD)

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Accepted

Interventions

• LY4560736 — DRUG
  Administered intravenously (IV)
• LY4560736 — 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 LY4560736 is and to see how much and how quickly LY4560736 gets into the bloodstream. For healthy participants, the study also looks at how much LY4560736 gets into the brain. This part of the study lasts up to 13 weeks which includes staying in the Clinical Research Unit (CRU) for at least 4 days. This group will include Japanese participants, and the Sponsor may choose to enroll Chinese participants. 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 13 weeks which includes staying in the CRU twice, each lasts about 1 to 2 days. Japanese participants, and potentially Chinese participants, may also be enrolled in this group.

Key Dates

First listed

Sep 28, 2026

Start date

Oct 31, 2026

Status verified

Oct 2026

Primary completion

Jul 31, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

111 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: LY4560736 Part A: Single-Ascending Dose (SAD)
  LY4560736 administered intravenously (IV) or subcutaneously (SC) in healthy volunteers.
• Placebo Comparator: Placebo Part A
  Placebo administered IV or SC in healthy volunteers.
• Experimental: LY4560736 Part B: Multiple Ascending Dose (MAD)
  LY4560736 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 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 13 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 (13)

Find similar trials in Anaheim, CA

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