LY4256984 for ALS
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates the safety and tolerability of the drug LY4256984 for individuals with sporadic ALS, a condition affecting nerve cells in the brain and spinal cord. Administered through the spine, researchers aim to observe potential side effects and how the body processes the drug. Participants must have been diagnosed with sporadic ALS within the last two years and have a BMI of at least 18. 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 need to stop my current medications for the trial?
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 LY4256984 is likely to be safe for humans?
Research shows that LY4256984 remains in the early testing stages, meaning limited information exists about its safety in humans. These early studies aim to assess how well people with ALS tolerate the treatment and identify any side effects. Researchers typically begin with low doses, gradually increasing them to observe participants' reactions. As a Phase 1 trial, the primary focus is on safety and treatment tolerance. Participants are closely monitored for any adverse effects. Although specific safety information for LY4256984 is not yet available, this trial stage is crucial for understanding its safety.12345
Why do researchers think this study treatment might be promising for ALS?
Most treatments for ALS, like riluzole and edaravone, aim to slow disease progression. But LY4256984 is different because it uses a novel delivery method, being administered intrathecally, which means it's delivered directly into the spinal fluid. This approach can potentially target the central nervous system more effectively, offering hope for better outcomes. Researchers are excited because this method might lead to more significant benefits for patients by addressing the disease more directly at its source.
What evidence suggests that LY4256984 might be an effective treatment for ALS?
Research shows that LY4256984 is in the early stages of testing for treating sporadic amyotrophic lateral sclerosis (ALS). Currently, limited information from human studies exists regarding its effectiveness. In this trial, participants will receive either multiple ascending doses of LY4256984 or a placebo, both administered directly into the spine to target the nervous system, where ALS causes harm. The main goal is to assess the drug's tolerability and potential side effects. Although direct evidence of its effectiveness is not yet available, this method aims to address the root cause of nerve damage in ALS, offering a potential new way to manage the disease.13456
Who Is on the Research Team?
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 individuals with sporadic ALS, commonly known as Lou Gehrig's Disease. Participants must meet certain health criteria to be eligible, but specific inclusion and exclusion details are not provided in the information given.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Multiple ascending doses of LY4256984 administered intrathecally
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- LY4256984
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