32 Participants NeededMy employer runs this trial

LY4256984 for ALS

Recruiting at 10 trial locations
Tq
Pi
Overseen ByPhysicians interested in becoming principal investigators please contact
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Eli Lilly and Company
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new treatment called LY4256984 for people with Amyotrophic Lateral Sclerosis (ALS). ALS affects nerve cells in the brain and spinal cord, leading to muscle weakness. The trial aims to assess how well participants tolerate this treatment over 96 weeks. It is open to those who have already completed a related ALS study and have not experienced severe disease progression, such as requiring permanent mechanical ventilation, in their previous study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Do I need to stop my current medications for the trial?

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

Is there any evidence suggesting that LY4256984 is likely to be safe for humans?

Research has shown that LY4256984, a new treatment being tested for Amyotrophic Lateral Sclerosis (ALS), is currently under study to assess its safety and tolerability. Although detailed results from these studies are not yet available, the trial's early stage focuses on observing patient reactions and identifying any potential side effects.

In past studies of similar treatments, researchers have monitored for unwanted side effects and checked vital signs and lab results to ensure patient safety. This process helps establish a safety profile for the treatment as it progresses in research.

As an early-phase trial, the primary goal is to ensure the treatment's safety for people, which is a crucial step before evaluating its effectiveness. Careful monitoring and safety checks are essential components of the study.12345

Why are researchers excited about this trial?

Most treatments for ALS, like riluzole and edaravone, aim to slow the progression of the disease but have limited effectiveness. LY4256984 is unique because it is administered intrathecally, meaning it's delivered directly into the fluid surrounding the brain and spinal cord. This method could allow for more targeted delivery of the treatment, potentially improving its effectiveness. Researchers are excited because this approach might offer a more direct way to impact the disease process, potentially leading to better outcomes for patients.

What evidence suggests that LY4256984 might be an effective treatment for ALS?

Researchers are testing a drug called LY4256984 in this trial to determine its potential in treating Amyotrophic Lateral Sclerosis (ALS). Participants will receive LY4256984 administered directly into the fluid around the spine, which might enhance its delivery to the nervous system. Early studies primarily assess the safety of LY4256984 and patient tolerance. Solid evidence on its effectiveness for treating ALS is not yet available, as current studies do not focus on this aspect. The hope is that it might slow down ALS, but clinical trials have not yet proven this. Further research is necessary to confirm any benefits.13467

Who Is on the Research Team?

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 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 ALS who have completed a previous related study without serious unresolved side effects or other major illnesses. Participants must not have stopped the earlier treatment due to safety concerns or experienced severe disease progression like needing permanent ventilation.

Inclusion Criteria

To be considered a 'completer' of a parent study, the participant must finish the main treatment period/phase of the parent study as well as any off-treatment period/phase as described in the parent study's protocol.
Have completed an eligible parent study, as determined by the investigator. Eligible parent studies will be defined by the sponsor but will be clinical studies designed to evaluate a study intervention for the treatment of ALS.
Visits missed in a parent study will have no impact on the completer status of a potential participant.

Exclusion Criteria

During the parent study, the participant developed an unresolved SAE or a medical illness (other than ALS) that, in the opinion of the investigator, precludes either continued exposure to an IMP or participation in study procedures due to an unacceptable risk to the participant's safety.
During the parent study, the participant permanently or temporarily discontinued the investigational medicinal product (IMP), such that restarting the IMP would pose an unacceptable risk to the participant's safety, in the opinion of the investigator.
During the parent study, the participant experienced extreme ALS disease progression (for example, permanent mechanical ventilation) that poses an unacceptable risk to the participant's safety in the opinion of the investigator.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY4256984 administered intrathecally for the evaluation of safety and tolerability

96 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may continue to receive the study drug long-term to evaluate safety and tolerability

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • LY4256984

Trial Overview

The study is testing the safety and tolerability of a new drug called LY4256984 in people with ALS over at least 96 weeks. Only those from certain prior studies can join, and participants are assigned based on their previous treatments.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: LY4256984Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

A Study of LY4256984 in Participants With ... - Lilly Trials

The purpose of this study is to evaluate how well LY4256984 is tolerated and what side effects may occur in participants with sporadic amyotrophic lateral ...

A Substudy of LY4256984 in Participants With Sporadic ...

The main purpose of this study is to assess the long-term safety and tolerability of LY4256984 in participants with Amyotrophic Lateral ...

Lilly Extends ALS Pipeline With New Long-Term Safety ...

The treatment being tested is LY4256984, an experimental drug delivered directly into the spinal fluid. The aim is to see whether repeated ...

A Study of LY4256984 in Participants With Sporadic ...

The purpose of this study is to evaluate how well LY4256984 is tolerated and what side effects may occur in participants with sporadic amyotrophic lateral ...

A Study of LY4256984 in Participants With Sporadic ...

The purpose of this study is to evaluate how well LY4256984 is tolerated and what side effects may occur in participants with sporadic ...

A Substudy of LY4256984 in Participants With Sporadic ...

The main purpose of this study is to assess the long-term safety and tolerability of LY4256984 in participants with Amyotrophic Lateral ...

LY4256984 for ALS · Info for Participants

The studies aim to evaluate the safety and tolerability of different treatments in participants with Amyotrophic Lateral Sclerosis (ALS) that ...