A Phase 1 interventional study of LY4405094 and LY4405094 in Healthy Volunteers, Alzheimer Disease and Amyloid, sponsored by Eli Lilly and Company. Recruiting at 18 sites in 3 countries. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Treatment
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.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 68 is close to the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
LY4405094 administered intravenously (IV) or subcutaneously (SC) in healthy volunteers.
Drug: LY4405094
Placebo administered IV or SC in healthy volunteers.
Drug: Placebo
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 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
Administered intravenously (IV)
Administered Subcutaneously (SC)
Administered IV
Administered SC
Administered IV
Administered IV
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
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4405094 in Healthy Participants
Time frame: Baseline through Study Completion (Week 13)
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4405094 in Participants with Alzheimer's Disease (AD)
Time frame: Baseline through Study Completion (25 Weeks)
Change from Baseline of Cerebrospinal Fluid (CSF) Concentration of LY4405094 in Healthy Participants
Time frame: 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
Time frame: Baseline through Study Completion (25 Weeks)
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2025 (actual). Primary completion is estimated for Jan 2028, 27 months after the start.
Of 160 industry-sponsored phase 1 interventional studies under Alzheimer Disease, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's planned 27 months is above that.
Counting every sponsor, half of 233 studies reached it within 18 months; a quarter within 7 and three quarters within 39.
Start moved once since we started tracking on Sep 25, 2026: Sep 2026 → Oct 2025, on Oct 22, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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