A Study of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis

Last updated: March 5, 2026
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

1

Condition

Scar Tissue

Amyotrophic Lateral Sclerosis (Als)

Myasthenia Gravis (Chronic Weakness)

Treatment

LY4256984

Placebo

Clinical Study ID

NCT07100119
27427
EU trial number: 2025-521295-6
U1111-1321-6118
J6I-MC-OWAA
2025-521295-6
  • Ages 18-75
  • All Genders

Study Summary

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 sclerosis (ALS). The study drug will be administered intrathecally (IT) into the spine. Blood tests will be performed to check how much LY4256984 gets into the bloodstream and how long it takes the body to eliminate it.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a definite, possible, or probable diagnosis of sporadic amyotrophic lateralsclerosis (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 andless than or equal to 35.0 kilogram per square meter (kg/m²) (inclusive)

Exclusion

Exclusion Criteria:

  • Have a history or presence of medical illness including, but not limited to, anycardiovascular, renal, hepatic, gastrointestinal, respiratory, hematological,endocrine, psychiatric, or neurological disease, convulsions, or any clinicallysignificant laboratory abnormality

  • Have a history of another neurodegenerative disease or significant dementia/severecognitive problems

  • Have serum alanine aminotransferase (ALT), aspartate transferase (AST), or totalbilirubin levels greater than 2 x upper limit of normal.

  • Have a significant renal impairment (estimated glomerular filtration rate <60milliliters per minute [mL/min]/1.73 m²).

  • Have a 12-lead electrocardiogram (ECG) abnormality at screening, in the opinion ofthe investigator, that increases the risks associated with participating in thestudy

  • Show clinically significant abnormalities in lumbar spine previously known ordetermined by screening lumbar X-ray or fluoroscopy (if performed)

Study Design

Total Participants: 32
Treatment Group(s): 2
Primary Treatment: LY4256984
Phase: 1
Study Start date:
August 05, 2025
Estimated Completion Date:
September 30, 2027

Connect with a study center

  • UZ Leuven

    Leuven, 3000
    Belgium

    Active - Recruiting

  • UZ Leuven

    Leuven 2792482, 3000
    Belgium

    Site Not Available

  • Heritage Medical Research Clinic

    Calgary, T2N4Z6
    Canada

    Site Not Available

  • Heritage Medical Research Clinic

    Calgary 5913490, T2N4Z6
    Canada

    Site Not Available

  • Walter Mackenzie Health Sciences Centre

    Edmonton, T6G 2X8
    Canada

    Site Not Available

  • Walter Mackenzie Health Sciences Centre

    Edmonton 5946768, T6G 2X8
    Canada

    Site Not Available

  • London Health Sciences Centre

    London, N6A 5A5
    Canada

    Site Not Available

  • London Health Sciences Centre

    London 6058560, N6A 5A5
    Canada

    Site Not Available

  • Montreal Neurological Institute and Hospital

    Montreal, H3A 2B4
    Canada

    Active - Recruiting

  • Montreal Neurological Institute and Hospital

    Montreal 6077243, H3A 2B4
    Canada

    Site Not Available

  • Sunnybrook Research Institute

    Toronto, M4N 3M5
    Canada

    Active - Recruiting

  • Sunnybrook Research Institute

    Toronto 6167865, M4N 3M5
    Canada

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, 23538
    Germany

    Active - Recruiting

  • Universitätsklinikum Schleswig-Holstein

    Lübeck 2875601, 23538
    Germany

    Site Not Available

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

    Rostock, 18147
    Germany

    Site Not Available

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

    Rostock 2844588, 18147
    Germany

    Site Not Available

  • Universitätsklinikum Ulm

    Ulm, 89081
    Germany

    Site Not Available

  • Universitätsklinikum Ulm

    Ulm 2820256, 89081
    Germany

    Site Not Available

  • Universitair Medisch Centrum Utrecht

    Utrecht, 3584
    Netherlands

    Active - Recruiting

  • Universitair Medisch Centrum Utrecht

    Utrecht 2745912, 3584
    Netherlands

    Site Not Available

  • Hospital Universitario de Bellvitge

    Hospitalet del Llobregat, Barcelona 8907
    Spain

    Site Not Available

  • Hospital Universitario de Bellvitge

    L'Hospitalet De Llobregat, Barcelona 08907
    Spain

    Site Not Available

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, 8907
    Spain

    Active - Recruiting

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat 3120619, 8907
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia 2509954, 46026
    Spain

    Site Not Available

  • Hospital Universitari i Politecnic La Fe

    València, 46026
    Spain

    Site Not Available

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