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New ALS drug injected into spine begins human testing

NCT ID NCT07100119

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tests a new drug called LY4256984 in 32 people with sporadic ALS. The drug is injected into the spine to see if it is safe and how the body handles it. The main goal is to check for side effects, not yet to prove it works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LY4256984 (given as an injection into the spine)
What this could lead to
If successful, this could point toward a treatment that slows or controls ALS progression.
What could go wrong
This is a very early Phase 1 trial with only 32 people, focused on safety. It is too soon to know if the drug works, and it may cause side effects or fail in later studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 32 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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) Exclusion Criteria: * 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). * Have a 12-lead electrocardiogram (ECG) abnormality at screening, in the opinion of the investigator, that increases the risks associated with participating in the study * Show clinically significant abnormalities in lumbar spine previously known or determined by screening lumbar X-ray or fluoroscopy (if performed)

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis sporadic amyotrophic lateral sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ALS (amyotrophic lateral sclerosis)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Heritage Medical Research Clinic

    NOT_YET_RECRUITING

    Calgary, T2N4Z6, Canada

  • Hospital Universitari i Politecnic La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario de Bellvitge

    RECRUITING

    L'Hospitalet de Llobregat, 8907, Spain

  • London Health Sciences Centre

    NOT_YET_RECRUITING

    London, N6A 5A5, Canada

  • Montreal Neurological Institute and Hospital

    RECRUITING

    Montreal, H3A 2B4, Canada

  • Sunnybrook Research Institute

    RECRUITING

    Toronto, M4N 3M5, Canada

  • UZ Leuven

    RECRUITING

    Leuven, 3000, Belgium

  • Universitair Medisch Centrum Utrecht

    RECRUITING

    Utrecht, 3584, Netherlands

  • Universitätsklinikum Schleswig-Holstein

    RECRUITING

    Lübeck, 23538, Germany

  • Universitätsklinikum Ulm

    NOT_YET_RECRUITING

    Ulm, 89081, Germany

  • Universitätsmedizin Rostock Sektion für Translationale Neurodegeneration "Albrecht Kossel" Klinik und Poliklinik für Neurologie

    NOT_YET_RECRUITING

    Rostock, 18147, Germany

  • Walter Mackenzie Health Sciences Centre

    NOT_YET_RECRUITING

    Edmonton, T6G 2X8, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.