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A Study of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis

NCT ID: NCT07100119

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-05

Study Completion Date

2027-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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ALS (Amyotrophic Lateral Sclerosis)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY4256984 (Cohorts 1-4)

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

Group Type EXPERIMENTAL

LY4256984

Intervention Type DRUG

Administered IT

Placebo

Administered IT

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered IT

Interventions

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LY4256984

Administered IT

Intervention Type DRUG

Placebo

Administered IT

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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UZ Leuven

Leuven, , Belgium

Site Status NOT_YET_RECRUITING

Heritage Medical Research Clinic

Calgary, , Canada

Site Status NOT_YET_RECRUITING

Walter Mackenzie Health Sciences Centre

Edmonton, , Canada

Site Status NOT_YET_RECRUITING

London Health Sciences Centre

London, , Canada

Site Status NOT_YET_RECRUITING

Montreal Neurological Institute and Hospital

Montreal, , Canada

Site Status RECRUITING

Sunnybrook Research Institute

Toronto, , Canada

Site Status RECRUITING

Universitätsklinikum Schleswig-Holstein

Lübeck, , Germany

Site Status NOT_YET_RECRUITING

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

Rostock, , Germany

Site Status NOT_YET_RECRUITING

Universitätsklinikum Ulm

Ulm, , Germany

Site Status NOT_YET_RECRUITING

Universitair Medisch Centrum Utrecht

Utrecht, , Netherlands

Site Status NOT_YET_RECRUITING

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Site Status NOT_YET_RECRUITING

Countries

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Belgium Canada Germany Netherlands Spain

Central Contacts

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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Role: CONTACT

Phone: 1-317-615-4559

Email: [email protected]

Physicians interested in becoming principal investigators please contact

Role: CONTACT

Email: [email protected]

Facility Contacts

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Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Role: primary

Other Identifiers

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J6I-MC-OWAA

Identifier Type: OTHER

Identifier Source: secondary_id

2025-521295-6

Identifier Type: OTHER

Identifier Source: secondary_id

U1111-1321-6118

Identifier Type: OTHER

Identifier Source: secondary_id

27427

Identifier Type: -

Identifier Source: org_study_id