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

Part of paid clinical trials in Anaheim, California.

Sponsor
Eli Lilly and Company
Study ID
NCT07787182
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

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
Sep 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 (13)

FacilityCityStateZIPSite coordinators
CenExel ACTAnaheimCalifornia92801
714-774-7777
Amina Haggag (PRINCIPAL_INVESTIGATOR)
Irvine Clinical ResearchIrvineCalifornia92614
949-753-1663
Elly Lee (PRINCIPAL_INVESTIGATOR)
Collaborative Neuroscience Network - CNSLos AlamitosCalifornia90720
714-799-7799
Steven Reynolds (PRINCIPAL_INVESTIGATOR)
Fortrea Clinical Research UnitDaytona BeachFlorida32117
386-366-6400
Chiamaka Iheme (PRINCIPAL_INVESTIGATOR)
K2 Medical Research - The VillagesLady LakeFlorida32159
321-278-5590
Craig Curtis (PRINCIPAL_INVESTIGATOR)
K2 Medical ResearchMaitlandFlorida32751
407-232-9262
Brandon Lenox (PRINCIPAL_INVESTIGATOR)
Charter ResearchOrlandoFlorida32803
407-337-1000
Diana Balsalobre (PRINCIPAL_INVESTIGATOR)
Progressive Medical ResearchPort OrangeFlorida32127
386-304-7070
Alexander White (PRINCIPAL_INVESTIGATOR)
Alzheimer's Research and Treatment CenterStuartFlorida34996
772-675-0000
Adam Falchook (PRINCIPAL_INVESTIGATOR)
K2 Medical Research - TampaTampaFlorida33634
813-800-5252
Kelley Wilson (PRINCIPAL_INVESTIGATOR)
Charter ResearchThe VillagesFlorida32162-2698
352-775-1000
Jeffrey Norton (PRINCIPAL_INVESTIGATOR)
Accel Research Sites - NeuroStudies Clinical Research UnitDecaturGeorgia30030
404-475-0552
Marshall Nash (PRINCIPAL_INVESTIGATOR)
QUEST Research InstituteFarmington HillsMichigan48334
248-957-8940
Aaron Ellenbogen (PRINCIPAL_INVESTIGATOR)

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