Health TrialsbyHealthPanel

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

ConditionsHealthy VolunteersAlzheimer DiseaseAmyloidPlaque, Amyloid
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY4405094

    Drug

    Administered intravenously (IV)

  • LY4405094

    Drug

    Administered Subcutaneously (SC)

  • Placebo

    Drug

    Administered IV

  • Placebo

    Drug

    Administered SC

  • Florbetapir F18

    Other intervention

    Administered IV

  • Florbetaben F 18

    Other intervention

    Administered IV

Treatment groups

68 Participants
are divided into 4 treatment groups
Group A: LY4405094 Part A: Single-Ascending Dose (SAD)Experimental treatment 1 intervention
Group B: Placebo Part APlacebo comparator 1 intervention
Group C: LY4405094 Part B: Multiple Ascending Dose (MAD)Experimental treatment 3 interventions
Group D: Placebo Part BPlacebo comparator 3 interventions

Trial outcomes

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

Time frame
Baseline up to 25 Weeks

Secondary outcomes

1

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

Time frame
Baseline through Study Completion (Week 13)
2

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)
3

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

Time frame
Baseline through Study Completion (Week 13)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: