Recruiting

LY4256984 for Sporadic Amyotrophic Lateral Sclerosis

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

LY4256984

+ Placebo

Drug
Who is being recruted

Amyotrophic Lateral Sclerosis+8

+ Central Nervous System Diseases

+ Metabolic Diseases

From 18 to 75 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-ControlledPhase 1
Interventional
Study Start: August 2025
See protocol details

Summary

Principal SponsorEli Lilly and Company
Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) orMore contacts
Last updated: December 25, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: August 5, 2025

Actual date on which the first participant was enrolled.

This study focuses on understanding how a new drug, LY4256984, works in people with a condition called sporadic amyotrophic lateral sclerosis (ALS). ALS is a progressive nervous system disease that affects nerve cells in the brain and spinal cord, causing loss of muscle control. The main goal is to see how well people tolerate this drug and identify any side effects. This research is important because it may lead to better treatment options for those living with ALS, who currently have limited therapeutic options. Participants in the study receive LY4256984 through an injection into the spine, a method called intrathecal administration. Blood tests are conducted to determine how much of the drug enters the bloodstream and how quickly the body processes and eliminates it. This helps researchers understand the drug's behavior in the body. While the study aims to uncover potential benefits, it also carefully monitors for any side effects to ensure participant safety.

Official TitleA Multiple Ascending Dose Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally Administered LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis 
NCT07100119
Principal SponsorEli Lilly and Company
Study ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) orMore contacts
Last updated: December 25, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

32 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Amyotrophic Lateral SclerosisCentral Nervous System DiseasesMetabolic DiseasesNervous System DiseasesNeuromuscular DiseasesNutritional and Metabolic DiseasesSpinal Cord DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesProteostasis DeficienciesTDP-43 Proteinopathies

Criteria

3 inclusion criteria required to participate
Have a definite, possible, or probable diagnosis of sporadic amyotrophic lateral sclerosis (ALS) made by a physician experienced with the management of ALS
ALS symptom onset as determined by the Investigator within 24 months of Screening
Have a body mass index (BMI) within the range of greater than or equal to 18.0 and less than or equal to 35.0 kilogram per square meter (kg/m²) (inclusive)
6 exclusion criteria prevent from participating
Have a history or presence of medical illness including, but not limited to, any cardiovascular, renal, hepatic, gastrointestinal, respiratory, hematological, endocrine, psychiatric, or neurological disease, convulsions, or any clinically significant laboratory abnormality
Have a history of another neurodegenerative disease or significant dementia/severe cognitive problems
Have serum alanine aminotransferase (ALT), aspartate transferase (AST), or total bilirubin levels greater than 2 x upper limit of normal.
Have a significant renal impairment (estimated glomerular filtration rate <60 milliliters per minute [mL/min]/1.73 m²).
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
Multiple ascending doses (MAD) of LY4256984 administered intrathecally (IT)

Group II

Placebo
Administered IT

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 12 locations

Recruiting

Montreal Neurological Institute and Hospital

Montreal, CanadaSee the location
Recruiting

Sunnybrook Research Institute

Toronto, Canada
Recruiting soon

UZ Leuven

Leuven, Belgium
Recruiting soon

Heritage Medical Research Clinic

Calgary, Canada
Recruiting
12 Study Centers