A Study of LY4006895 in Healthy Participants With Early Symptomatic Alzheimer's Disease (AD)

Phase 1

Recruiting

• Conditions: Alzheimer Disease; Healthy
• Interventions: Drug: LY4006895; Drug: Placebo

• Registration Number: NCT06657768
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY4006895. Part A will administer a single-ascending dose in healthy participants or Part B will administer multiple-ascending doses in participants with early symptomatic Alzheimer's Disease (AD).

Blood tests will be performed to check how much LY4006895 gets into the bloodstream and how long it takes the body to eliminate it.

This is a 2-part study and will last approximately 29 weeks for Part A and 61 weeks for Part B, including a screening period for each part.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-23
• Study First Submitted QC: 2024-10-23
• Study First Posted: 2024-10-24
• Study Start: 2024-10-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-02-28
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY4006895 of Part A (SAD)	LY4006895	Single-ascending doses of LY4006895 administered intravenously (IV)
Placebo Part A	Placebo	Placebo administered IV
LY4006895 of Part B (MAD)	LY4006895	Multiple-ascending doses of LY4006895 will be administered IV
Placebo Part B	Placebo	Placebo administered IV

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Discontinuations due to Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration	Baseline to Study Completion (Up to 61 Weeks)	A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Name	Time	Method
PK: Maximum Concentration (Cmax) of LY4006895	Baseline to Study Completion (Up to 61 Weeks)	PK: Cmax of LY4006895
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4006895	Baseline to Study Completion (Up to 61 Weeks)	PK: AUC of LY4006895

Trial Locations

Locations (5)

Atlanta Center of Medical Research; 🇺🇸 Atlanta, Georgia, United States

CenExel iResearch, LLC (CenExel iRA); 🇺🇸 Decatur, Georgia, United States

Duke Early Phase Research Unit; 🇺🇸 Durham, North Carolina, United States

Collaborative Neuroscience Network - CNS; 🇺🇸 Los Alamitos, California, United States

CenExel-HRI; 🇺🇸 Marlton, New Jersey, United States