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

Lilly

Status and phase: Not yet enrolling; Phase 1

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

Treatments: Drug: LY4560736; Other: Florbetapir F18; Other: Florbetaben F 18; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07843459

A1D-MC-AT02 (Other Identifier)

A1D-MC-ATMP (Other Identifier)

27911

Details and patient eligibility

About

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.

Enrollment: 111 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Participants must meet eligibility criteria in the A1D-MC-ATMP screening protocol before entry into the treatment study.
• To qualify as a participant of first-generation Japanese origin, the participant, the participant's biological parents, and all the participant's biological grandparents must be of exclusive Japanese descent and born in Japan.
• To qualify as Chinese for this study, all four of the participant's biological grandparents must be of exclusive Chinese descent and born in China.

Exclusion criteria

• Have a condition that predisposes the participant to an infection.
• Have a current or recent acute, active infection.
• Have active tuberculosis (TB), have or have had latent TB.
• Are receiving therapeutic antibodies or expected to initiate treatment with therapeutic antibodies during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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111 participants in 4 patient groups, including a placebo group

LY4560736 Part A: Single-Ascending Dose (SAD)

Experimental group

Description:

LY4560736 administered intravenously (IV) or subcutaneously (SC) in healthy volunteers.

Treatment:

Drug: LY4560736

Drug: LY4560736

Placebo Part A

Placebo Comparator group

Description:

Placebo administered IV or SC in healthy volunteers.

Treatment:

Drug: Placebo

Drug: Placebo

LY4560736 Part B: Multiple Ascending Dose (MAD)

Experimental group

Description:

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.

Treatment:

Drug: LY4560736

Other: Florbetaben F 18

Other: Florbetapir F18

Drug: LY4560736

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 PET scan.

Treatment:

Drug: Placebo

Drug: Placebo

Other: Florbetaben F 18

Other: Florbetapir F18