RecruitingRecruiting
A Study of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis
NCT07100119 · Eli Lilly and Company
In plain English
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Official title
A 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
About this study
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 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)
Study design
Enrollment target: 32 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-08-05
Estimated completion: 2027-09
Last updated: 2026-03-06
Interventions
Drug: LY4256984Drug: Placebo
Primary outcomes
- • Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs), Serious Adverse Event(s) (SAEs), and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration (Baseline up to Approximately Day 253)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 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) · study_director, Eli Lilly and Company
All locations (12)
UZ LeuvenRecruiting
Leuven, Belgium
Heritage Medical Research ClinicNot Yet Recruiting
Calgary, Canada
Walter Mackenzie Health Sciences CentreNot Yet Recruiting
Edmonton, Canada
London Health Sciences CentreNot Yet Recruiting
London, Canada
Montreal Neurological Institute and HospitalRecruiting
Montreal, Canada
Sunnybrook Research InstituteRecruiting
Toronto, Canada
Universitätsklinikum Schleswig-HolsteinRecruiting
Lübeck, Germany
Universitätsmedizin Rostock Sektion für Translationale Neurodegeneration "Albrecht Kossel" Klinik und Poliklinik für NeurologieNot Yet Recruiting
Rostock, Germany
Universitätsklinikum UlmNot Yet Recruiting
Ulm, Germany
Universitair Medisch Centrum UtrechtRecruiting
Utrecht, Netherlands
Hospital Universitario de BellvitgeRecruiting
L'Hospitalet de Llobregat, Spain
Hospital Universitari i Politecnic La FeRecruiting
Valencia, Spain