NCT06657768 is a Phase 1 clinical trial evaluating LY4006895, an investigational therapeutic agent developed by Eli Lilly and Company, in healthy participants and patients with early symptomatic Alzheimer's disease (AD). This first-in-human study aims to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of LY4006895 administered intravenously.
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Overview
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NCT06657768 is a Phase 1 clinical trial evaluating LY4006895, an investigational therapeutic agent developed by Eli Lilly and Company, in healthy participants and patients with early symptomatic Alzheimer's disease (AD). This first-in-human study aims to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of LY4006895 administered intravenously.
LY4006895 represents Eli Lilly's continued investment in Alzheimer's disease therapeutics following their previous work with other anti-amyloid and anti-tau agents. The study is designed as a two-part trial (Part A and Part B) to first establish safety in healthy volunteers before evaluating the therapeutic in the target patient population.
Trial Details
| Parameter | Value | |-----------|-------| | NCT Number | NCT06657768 | | Phase | Phase 1 | | Status | RECRUITING | | Sponsor | Eli Lilly and Company | | Study Type | Interventional | | Intervention | LY4006895 (IV infusion) | | Comparator | Placebo (IV infusion) | | Estimated Completion | July 2027 | | Age Range | 45-85 years |
Study Design
Part A: Healthy Participants
The first part of the trial enrolls healthy volunteers to establish the safety and tolerability profile of LY4006895. This portion of the study:
Determines safe dose ranges
Characterizes pharmacokinetic parameters
Establishes baseline safety markers
Identifies potential adverse events
Part B: Early Symptomatic AD Patients
The second part evaluates LY4006895 in patients with early symptomatic Alzheimer's disease. This population represents the intended therapeutic indication and allows assessment of:
Target engagement biomarkers
Preliminary efficacy signals
Disease modification endpoints
Patient Population
Inclusion Criteria
Age: 45-85 years
BMI: 18-40 kg/m²
Part B Specific:
Early symptomatic AD diagnosis
MMSE score: 18-30
CDR global score: 0.5-1.0
Exclusion Criteria
Serious or unstable medical conditions
Iron deficiency
Suicidal risk or ideation
Current drug or substance abuse
Prior anti-tau therapy exposure
Pregnancy or breastfeeding
Any condition that could interfere with study participation
Study Locations
The trial is conducted at multiple sites across the United States and Japan:
United States
California (multiple sites)
Florida
Georgia
New Jersey
North Carolina
Japan
Tokyo
Ōbu
Some sites may not yet be recruiting at the time of this summary.
Mechanism of Action
While detailed mechanism of action information is limited at this early stage of development, the LY4006895 program represents Eli Lilly's strategic approach to Alzheimer's disease modification. Based on the company's pipeline and historical development programs, this agent likely targets one or more key pathological pathways in AD:
Potential Mechanisms
Given Eli Lilly's prior work in the AD therapeutic space, LY4006895 may target:
Amyloid-beta pathology: Aggregation inhibitors or anti-aggregated antibody approaches
Tau pathology: Anti-tau antibodies or small molecules
[A Study of LY4006895 in Healthy Participants With Early Symptomatic Alzheimer's Disease (AD) - NCT06657768](https://clinicaltrials.gov/study/NCT06657768)