Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's Disease) Clinical Trials
Find Amyotrophic Lateral Sclerosis (ALS or Lou Gehrig's Disease) Clinical Trials Near You
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
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
Belgium
UZ Leuven
RECRUITING
Leuven
Canada
Heritage Medical Research Clinic
NOT_YET_RECRUITING
Calgary
Walter Mackenzie Health Sciences Centre
NOT_YET_RECRUITING
Edmonton
London Health Sciences Centre
NOT_YET_RECRUITING
London
Montreal Neurological Institute and Hospital
RECRUITING
Montreal
Sunnybrook Research Institute
RECRUITING
Toronto
Germany
Universitätsklinikum Schleswig-Holstein
RECRUITING
Lübeck
Universitätsmedizin Rostock Sektion für Translationale Neurodegeneration Albrecht Kossel Klinik und Poliklinik für Neurologie
NOT_YET_RECRUITING
Rostock
Universitätsklinikum Ulm
NOT_YET_RECRUITING
Ulm
Netherlands
Universitair Medisch Centrum Utrecht
RECRUITING
Utrecht
Spain
Hospital Universitario de Bellvitge
RECRUITING
L'hospitalet De Llobregat
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date:2025-08-05
Estimated Completion Date:2027-09
Participants
Target number of participants:32
Treatments
Experimental: LY4256984 (Cohorts 1-4)
Multiple ascending doses (MAD) of LY4256984 administered intrathecally (IT)