A Study of LY3372689 to Assess the Safety, Tolerability, and Efficacy in Participants With Alzheimer's Disease

Lilly

Status and phase: Completed; Phase 2

Conditions: Alzheimer Disease

Treatments: Drug: Placebo; Drug: LY3372689

Study type: Interventional

Funder types: Industry

Identifiers

NCT05063539

2024-512295-36-00 (EU Trial (CTIS) Number)

I9X-MC-MTAE (Other Identifier)

2021-000170-29 (EudraCT Number)

18094

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability and effect of study drug LY3372689 in participants with early symptomatic Alzheimer's Disease

Enrollment: 327 patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

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 screening
• CDR global score of 0.5 to 1.0 (inclusive), with a memory box score ≥0.5.
• Meet 18F flortaucipir positron emission tomography (PET) scan (central analysis) criteria
• Have a study partner who will provide written informed consent to participate

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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327 participants in 3 patient groups, including a placebo group

0.75 Milligram (mg) LY3372689

Experimental group

Description:

Double-blind treatment period: Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks. Post treatment follow up period: Participants who received 0.75 mg LY3372689 during the double-blind treatment period entered a post-treatment follow-up period for 4 weeks after last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety monitoring. Post treatment observational extension period: Participants who received 0.75 mg LY3372689 during the double-blind treatment period had the option to enter post-treatment observational extension period for approximately 9 months on average since last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety, other/exploratory efficacy and biomarker monitoring.

Treatment:

Drug: LY3372689

Drug: LY3372689

3 mg LY3372689

Experimental group

Description:

Double-blind treatment period: Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks. Post treatment follow up period: Participants who received 3 mg LY3372689 during the double-blind treatment period entered a post-treatment follow-up period for 4 weeks after last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety monitoring. Post treatment observational extension period: Participants who received 3 mg LY3372689 during the double-blind treatment period had the option to enter post-treatment observational extension period for approximately 9 months on average since last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety, other/exploratory efficacy and biomarker monitoring.

Treatment:

Drug: LY3372689

Drug: LY3372689

Placebo

Placebo Comparator group

Description:

Double-blind treatment period: Participants received placebo administered orally once daily for up to 124 weeks. Post treatment follow up period: Participants who received placebo during the double-blind treatment period entered a post-treatment follow-up period for 4 weeks after last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety monitoring. Post treatment observational extension period: Participants who received placebo during the double-blind treatment period had the option to enter post-treatment observational extension period for approximately 9 months on average since last blinded treatment dose. No study intervention was administered during this period, and participants were followed for safety, other/exploratory efficacy and biomarker monitoring.

Treatment:

Drug: Placebo