Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| J6I-MC-OWAA | Other Identifier | Eli Lilly and Company | |
| 2025-521295-6 | Other Identifier | EU CTR # | |
| U1111-1321-6118 | Other Identifier | World Health Organization (WHO) |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LY4256984 (Cohorts 1-4) | Experimental | Multiple ascending doses (MAD) of LY4256984 administered intrathecally (IT) |
|
| Placebo | Placebo Comparator | Administered IT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LY4256984 | Drug | Administered IT |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | A summary of TEAEs, SAEs, and AEs regardless of causality, will be reported in the Reported Adverse Events module | Baseline up to Approximately Day 253 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK): Plasma Area Under the Concentration Versus Time Curve (AUC) of LY4256984 | PK: Plasma AUC of LY4256984 | Baseline up to Approximately Day 253 |
| PK: Plasma Maximum Concentration (Cmax) of LY4256984 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or | Contact | 1-317-615-4559 | LillyTrials@Lilly.com | |
| Physicians interested in becoming principal investigators please contact | Contact | clinical_inquiry_hub@lilly.com |
| Name | Affiliation | Role |
|---|---|---|
| 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) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Recruiting | Leuven | 3000 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Administered IT |
|
PK: Plasma Cmax of LY4256984
| Baseline up to Approximately Day 253 |
| PK: Cerebrospinal Fluid Concentrations (CSF) of LY4256984 | PK: CSF Concentrations of LY4256984 | Baseline up to Approximately Day 253 |
| Heritage Medical Research Clinic | Not yet recruiting | Calgary | T2N4Z6 | Canada |
|
| Walter Mackenzie Health Sciences Centre | Not yet recruiting | Edmonton | T6G 2X8 | Canada |
|
| 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 |
|
| Universitätsklinikum Schleswig-Holstein | Recruiting | Lübeck | 23538 | Germany |
|
| Universitätsmedizin Rostock Sektion für Translationale Neurodegeneration "Albrecht Kossel" Klinik und Poliklinik für Neurologie | Not yet recruiting | Rostock | 18147 | Germany |
|
| Universitätsklinikum Ulm | Not yet recruiting | Ulm | 89081 | Germany |
|
| Universitair Medisch Centrum Utrecht | Recruiting | Utrecht | 3584 | Netherlands |
|
| Hospital Universitario de Bellvitge | Recruiting | L'Hospitalet de Llobregat | 8907 | Spain |
|
| Hospital Universitari i Politecnic La Fe | Recruiting | Valencia | 46026 | Spain |
|
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |