Pure Global AI
NCT06297590Not yet recruiting

A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease

A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3954068 in Patients With Early Symptomatic Alzheimer's Disease
Eli Lilly and CompanyPhase 1ClinicalTrials.govdrug
Study focus
Disease/Condition
Alzheimer Disease
Drug/Device/Intervention
LY3954068
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Eli Lilly and Company
Location
Maitland,The Villages,Indianapolis,Charlestown,Toms River,Durham,Milwaukee,Bunkyo-ku,London,Sheffield,Southampton, Japan,United Kingdom,United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Jun 01, 2024
End date
Feb 01, 2027
Enrollment
60 participants
Primary outcome

Part A: Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration,Part B: Number of participants with one or more Adverse Event (s) (AEs), Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration

Summary

The main purpose of this study is to evaluate the safety of LY3954068 in participants with
 early symptomatic Alzheimer's Disease (AD). The study will also investigate how much
 LY3954068 gets into the bloodstream and will test the effects of LY3954068 on markers of AD.
 
 The study will be comprised of two parts, A and B. Part B is optional, and participants from
 Part A may also have the opportunity to join an optional bridging period to a separate
 potential study where participants would receive LY3954068. Each enrolled participant in Part
 A will receive a single dose of LY3954068 or placebo (no active drug) given into the spinal
 fluid. If conducted, each participant in Part B would receive 2 doses of either LY3954068 or
 placebo administered into the spinal fluid.
 
 The study will last up to approximately 69 weeks for Part A, and, if conducted, 73 weeks for
 Part B. If conducted, the optional bridging period for Part A participants would last up to
 approximately 1 year after their completion of Part A.
 
 If the optional bridging period is conducted, participants in Part A could be enrolled in the
 separate potential study for up to approximately 120 weeks.

ICD-10 classifications
Alzheimer diseaseAlzheimer disease, unspecifiedOther Alzheimer diseaseDementia in Alzheimer diseaseDementia in Alzheimer disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06297590
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06297590 through Pure Global AI's free database. This Phase 1 trial is sponsored by Eli Lilly and Company and is currently Not yet recruiting. The study focuses on Alzheimer Disease. Target enrollment is 60 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.