LY3372689 for Alzheimer's Disease

No longer recruiting at 103 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Disqualifiers: Allergies to LY3372689, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 76 to 124 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, LY3372689, to determine its safety and effectiveness for individuals with early symptoms of Alzheimer's disease. Participants will take either the drug or a placebo (a pill with no active ingredient) daily for up to 124 weeks. The goal is to assess the drug's impact on memory and cognitive function. It suits those who have experienced gradual memory changes for at least six months and have a reliable study partner willing to participate. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that LY3372689 is generally safe based on earlier studies. In tests with healthy participants, LY3372689 was well-tolerated, with no serious side effects reported from either single or multiple doses. These studies provide some confidence about its safety for individuals with Alzheimer's disease. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's?

Researchers are excited about LY3372689 because it offers a new approach to treating Alzheimer's disease. Unlike most current treatments, which primarily focus on managing symptoms, LY3372689 is designed to target underlying disease mechanisms. This drug acts on specific pathways in the brain that are believed to contribute to Alzheimer's progression, offering hope for slowing or altering the course of the disease rather than just alleviating symptoms. Additionally, LY3372689 is administered orally, making it a convenient option for patients.

What evidence suggests that LY3372689 might be an effective treatment for Alzheimer's Disease?

Research shows that LY3372689, also known as ceperognastat, is under study for its potential to aid in early Alzheimer's disease. LY3372689 targets an enzyme called O-GlcNAcase, believed to be important for brain health. Early results suggest it could slow the worsening of Alzheimer's symptoms. While specific data on LY3372689's effectiveness is still being gathered, it builds on promising strategies used in other Alzheimer's treatments. More research is needed to confirm its benefits, but scientists consider this approach promising. ^{1 6 7 8 9}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for people with early symptomatic Alzheimer's Disease, who have experienced a gradual memory decline for at least 6 months. Participants should score between 22 to 30 on the MMSE (a cognitive test) and meet specific criteria on a PET brain scan. They need a study partner willing to consent as well.

Inclusion Criteria

Meet 18F flortaucipir positron emission tomography (PET) scan (central analysis) criteria

MMSE score of 22 to 30 (inclusive) at baseline

My memory has been getting worse for at least 6 months.

Exclusion Criteria

Have known allergies to LY3372689, related compounds, or any components of the formulations

Contraindication to MRI or PET scans

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY3372689 or placebo orally to assess safety, tolerability, and efficacy

76 to 124 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3372689
• Placebo

Trial Overview The trial is testing LY3372689, which is being investigated for safety and effectiveness in treating Alzheimer's. Participants will either receive LY3372689 or a placebo without knowing which one they are getting to compare results fairly.

How Is the Trial Designed?

Group I: 3 mg LY3372689 Experimental Treatment 1 Intervention

Participants received 3 mg LY3372689 administered orally once daily for up to 124 weeks.

Group II: 0.75 Milligram (mg) LY3372689 Experimental Treatment 1 Intervention

Participants received 0.75 mg LY3372689 administered orally once daily for up to 124 weeks

Group III: Placebo Placebo Group 1 Intervention

Participants received placebo administered orally once daily for up to 124 weeks.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05063539

A Study of LY3372689 to Assess the Safety, Tolerability, ... 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10544555/

Clinical trials of new drugs for Alzheimer disease In the TRAILBLAZER-ALZ study, donanemab slowed disease progression by 32% at 18 months (p = 0.04 vs. placebo), thus demonstrating clinical efficacy [51].

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05063539?term=%22Institute%20for%20Neurodegenerative%20Disorders%22%20OR%20%20%22Molecular%20Neurolmaging%22%20OR%20%22Molecular%20Neuroimaging;%20MRI%2FPET%22&aggFilters=status:rec%20enr%20act&viewType=Table&rank=5

A Study of LY3372689 to Assess the Safety, Tolerability, and ... Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex ...

4. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/trc2.70020

Discovery and clinical translation of ceperognastat, an O ... A multidisciplinary approach was used to identify ceperognastat (LY3372689) as a potent OGA inhibitor, including an extensive discovery effort.

5. en.wikipedia.org en.wikipedia.org/wiki/Ceperognastat

Ceperognastat Ceperognastat (LY3372689) is a drug candidate molecule under investigation to treat Alzheimer's disease. It targets the enzyme O-GlcNAcase.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39748851/

Discovery and clinical translation of ceperognastat, an O ... Ceperognastat had an acceptable safety profile in Phase 1 clinical studies. Keywords: Alzheimer's disease; O‐GlcNAcase inhibition; O‐ ...

7. trials.lilly.com trials.lilly.com/en-US/trial/306063

A Study of LY3372689 to Assess the Safety, Tolerability, and ... 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.

8. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/abs/10.1002/alz.057728

Single and multiple ascending dose studies in healthy ... LY3372689 demonstrated an acceptable safety and PK profile following single and multiple doses of LY3372689 in HV. These results support ...

9. trial.medpath.com trial.medpath.com/clinical-trial/c138f1bb6034851f/euctr2021-000170-29-pl-safety-tolerability-efficacy-ly3372689-alzheimers-disease

Assessment of Safety, Tolerability, and Efficacy of (LY3372689 ... •Gradual and progressive change in memory function reported by participants or informants for = 6 months •MMSE score of 22 to 30 (inclusive) at baseline