Assessment of Safety, Tolerability, and Efficacy of (LY3372689) in Participants With Alzheimer’s Disease

Assessment of Safety, Tolerability, and Efficacy of LY3372689 in Early Symptomatic Alzheimer’s Disease

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000170-29-PL

Enrollment

340

Registered

2021-09-08

Start date

2021-11-05

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease MedDRA version: 20.0 Level: PT Classification code 10012271 Term: Dementia Alzheimer's type System Organ Class: 10029205 - Nervous system disorders

Interventions

Product Name: LY3372689 Product Code: LY3372689 Pharmaceutical Form: Tablet INN or Proposed INN: LY3372689 Current Sponsor code: LY3372689 Other descriptive name: LY3372689 Concentration unit: mg mill

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Gradual and progressive change in memory function reported by participants or informants for = 6 months • MMSE score of 22 to 30 (inclusive) at baseline • CDR global score of 0.5 to 1.0 (inclusive), with a memory box score =0.5. • Meet 18F flortaucipir PET scan (central analysis) criteria • Have a study partner who will provide written informed consent to participate Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 14 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 316

Exclusion criteria

Exclusion criteria: • Contraindication to MRI or PET scans • Have known allergies to LY3372689, related compounds, or any components of the formulations

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To assess the effect of LY3372689 vs. placebo on clinical progression in participants with early symptomatic AD with demonstrated presence of moderate levels of tau pathology ;Secondary Objective: 1. To assess the effect of LY3372689 vs. placebo on clinical progression in full study population (moderate + highc levels of tau pathology) with early symptomatic AD 2. To assess the effect of LY3372689 vs. placebo on clinical progression in full study population and moderate tau sub population with early symptomatic AD 3. To assess the effect of LY3372689 vs. placebo on brain region volumes 4. To assess the effect of LY3372689 vs. placebo on tau pathology biomarkers 5. To assess the PK of LY3372689 ;Primary end point(s): iADRS change from baseline through end time point;Timepoint(s) of evaluation of this end point: 76-124 weeks	—

Measure

Time frame

Main Objective: 1. To assess the effect of LY3372689 vs. placebo on clinical progression in participants with early symptomatic AD with demonstrated presence of moderate levels of tau pathology ;Secondary Objective: 1. To assess the effect of LY3372689 vs. placebo on clinical progression in full study population (moderate + highc levels of tau pathology) with early symptomatic AD 2. To assess the effect of LY3372689 vs. placebo on clinical progression in full study population and moderate tau sub population with early symptomatic AD 3. To assess the effect of LY3372689 vs. placebo on brain region volumes 4. To assess the effect of LY3372689 vs. placebo on tau pathology biomarkers 5. To assess the PK of LY3372689 ;Primary end point(s): iADRS change from baseline through end time point;Timepoint(s) of evaluation of this end point: 76-124 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): iADRS change from baseline through end time point;Timepoint(s) of evaluation of this end point: 76-124 weeks	—

Countries

Australia, Canada, Japan, Poland, United States

Contacts

Public ContactClinical Trial Registry Office

Eli Lilly

EU_Lilly_Clinical_Trials@lilly.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026