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

NCT07787182 | Not Yet Recruiting Phase 1 FDA Drug

• 4 other identifiers: 279102026-527295-81-00A1D-MC-AT01A1D-MC-ATMP
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 10

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  Baseline up to 25 Weeks

Secondary Outcomes (4)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4405094 in Healthy Participants

  Baseline through Study Completion (Week 13)

• PK: Area Under the Concentration Versus Time Curve (AUC) of LY4405094 in Participants with Alzheimer's Disease (AD)

  Baseline through Study Completion (25 Weeks)

• Change from Baseline of Cerebrospinal Fluid (CSF) Concentration of LY4405094 in Healthy Participants

  Baseline through Study Completion (Week 13)

• Change from Baseline of Amyloid Plaque levels as Assessed by Amyloid Positron Emission Tomography (PET) in Participants with AD

  Baseline through Study Completion (25 Weeks)

Study Arms (4)

LY4405094 Part A: Single-Ascending Dose (SAD)

EXPERIMENTAL

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

Drug: LY4405094

Placebo Part A

PLACEBO COMPARATOR

Placebo administered IV or SC in healthy volunteers.

Drug: Placebo

LY4405094 Part B: Multiple Ascending Dose (MAD)

EXPERIMENTAL

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.

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

Placebo Part B

PLACEBO COMPARATOR

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.

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

Interventions

LY4405094 DRUG

Administered intravenously (IV)

LY4405094 Part A: Single-Ascending Dose (SAD); LY4405094 Part B: Multiple Ascending Dose (MAD)

Placebo DRUG

Administered IV

Placebo Part A; Placebo Part B

Florbetapir F18 OTHER

Administered IV

LY4405094 Part B: Multiple Ascending Dose (MAD); Placebo Part B

Florbetaben F 18 OTHER

Administered IV

LY4405094 Part B: Multiple Ascending Dose (MAD); Placebo Part B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet eligibility criteria in the ATMP screening protocol before entry into the treatment study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (10)

Irvine Clinical Research

Irvine, California, 92614, United States

Location

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

K2 Medical Research - The Villages

Lady Lake, Florida, 32159, United States

Location

K2 Medical Research

Maitland, Florida, 32751, United States

Location

Charter Research

Orlando, Florida, 32803, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

K2 Medical Research - Tampa

Tampa, Florida, 33634, United States

Location

Charter Research

The Villages, Florida, 32162-2698, United States

Location

Accel Research Sites - NeuroStudies Clinical Research Unit

Decatur, Georgia, 30030, United States

Location

QUEST Research Institute

Farmington Hills, Michigan, 48334, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Plaque, Amyloid

Interventions

florbetapir; 4-(N-methylamino)-4'-(2-(2-(2-fluoroethoxy)ethoxy)ethoxy)stilbene

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)