NCT06657768

A Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, PK and PD of LY4006895 in Healthy Volunteers and Patients With Early Symptomatic AD

Recruiting now Phase 1 Last updated 2 June 2026

What this trial tests

Phase 1 trial testing LY4006895 in Alzheimer Disease in 128 participants. Currently enrolling.

Timeline

29 October 2024

Primary endpoint
1 July 2027

1 July 2027

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 1
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	basic science
Enrollment	128
Start date	29 October 2024
Primary completion	1 July 2027
Estimated completion	1 July 2027
Sites	13 locations across United States, Japan

Drugs / interventions tested

• LY4006895 — full drug profile →
• Placebo

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →
• Healthy — all drugs for Healthy →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 45 to 85, any sex, with Alzheimer Disease or Healthy. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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
  Time frame: 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

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Alzheimer's disease drug development pipeline: 2026.
   Cummings JL, Zhou Y, Yang Y, Zhong K, et al · · 2026 · PMID 42095064 · DOI 10.1002/trc2.70251