32 Participants NeededMy employer runs this trial

LY4256984 for ALS

Recruiting at 9 trial locations
Tq
Pi
Overseen ByPhysicians interested in becoming principal investigators please contact
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 a new treatment called LY4256984 for individuals with Amyotrophic Lateral Sclerosis (ALS), a condition affecting nerve cells in the brain and spinal cord. The trial aims to determine if this treatment is safe and well-tolerated over an extended period. Participants will receive the treatment directly into the spine. This study suits those who have completed a previous related trial and do not have conditions like severe back problems or allergies to certain local painkillers, which could make the procedure risky. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently taking anticoagulants or antiplatelet agents, except for low-dose aspirin.

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

An earlier study of LY4256984 examined how well patients with sporadic ALS tolerated the treatment and monitored for side effects. Although specific data from these studies is unavailable, it is important to note that this is an early-stage trial. These initial trials primarily focus on safety and may not yet provide extensive information on long-term effects. Since LY4256984 is administered directly into the spinal fluid, researchers closely monitor for any side effects. This trial builds on previous research, demonstrating ongoing interest in understanding the treatment's long-term safety.12345

Why do researchers think this study treatment might be promising for ALS?

Unlike the standard treatments for ALS, which often include medications like riluzole and edaravone, LY4256984 is administered intrathecally, meaning it's delivered directly into the spinal fluid. This delivery method allows the drug to target the nervous system more directly, potentially leading to more effective results. Researchers are excited about LY4256984 because it represents a novel approach that might offer benefits beyond what current oral or intravenous medications can provide. This could mean a breakthrough in how we manage ALS symptoms and progression.

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

Research shows that LY4256984 is in the early testing phase, focusing on safety and side effects rather than efficacy. In this trial, researchers administer LY4256984 directly into the spinal fluid, a common method for drugs targeting neurological conditions like ALS (Amyotrophic Lateral Sclerosis). Although detailed information on its effectiveness is not yet available, this approach targets the nervous system directly. Researchers believe this method might slow ALS progression by acting where the disease primarily affects the body. Early signs suggest a scientific basis for further exploration, but solid proof of its effectiveness in treating ALS is still needed.12567

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 already completed a previous related study (Study OWAA) and meet certain screening requirements. Participants must be able to safely undergo a lumbar puncture and cannot join if they have significant back problems, bleeding issues, or allergies to local anesthetics.

Inclusion Criteria

Participants must meet eligibility criteria in the L0U-MC-OLMP screening protocol before entry into the treatment study
Have completed the main treatment period/phase as well as any off-treatment period/phase of Study OWAA, the parent study for this ISA.

Exclusion Criteria

I have a condition that prevents me from having a lumbar puncture.
I have a history of serious back problems or injuries.
Allergy to local anesthetics, such as lidocaine or its derivatives
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intrathecal administration of LY4256984

96 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LY4256984

Trial Overview

The study is testing the long-term safety of an experimental drug called LY4256984 in people with ALS over about 96 weeks. It extends participation from a prior clinical trial and follows participants closely for side effects.

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 ...

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 ...

LY4256984 for ALS · Info for Participants

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