LY4256984 for ALS
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.12345Why 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?
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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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive LY4256984 administered intrathecally for the evaluation of safety and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension
Participants may continue to receive the study drug long-term to evaluate safety and tolerability
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
OL01 Substudy: LY4256984 administered intrathecally (IT)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
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
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 ...
3.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/LLY/pressreleases/1961423/lilly-extends-als-pipeline-with-new-long-term-safety-trial-for-ly4256984/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 ...
4.
trial.medpath.com
trial.medpath.com/clinical-trial/6eeab8d9bc497b7f/nct07100119-ly4256984-intrathecal-sporadic-als-safety-pharmacokineticsA 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 ...
5.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT07100119/a-study-of-ly4256984-in-participants-with-sporadic-amyotrophic-lateral-sclerosisA 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 ...
6.
ctv.veeva.com
ctv.veeva.com/study/a-substudy-of-ly4256984-in-participants-with-sporadic-amyotrophic-lateral-sclerosisA 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 ...
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