NCT07571174RecruitingPhase 1
A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis
A Study of Long-Term Safety, Tolerability, and Clinical Outcomes of Intrathecally Administered LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis: A Multicenter, Open-Label, Long-Term Extension of Study J6I-MC-OWAA
Source: ClinicalTrials.gov · Last updated 22 Sept 2026
Brief summary (registry, in English)
The main purpose of this study is to assess the long-term safety and tolerability of LY4256984 in participants with Amyotrophic Lateral Sclerosis (ALS). This study is a long-term extension of study J6I-MC-OWAA (NCT07100119) and is part of the OLMP (NCT07571200) master protocol that will last approximately 96 weeks.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- First submitted
- 30 Apr 2026
- Start date
- 14 May 2026
- Primary completion date
- Jun 2029
- Lead sponsor
- Eli Lilly and Company
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT07571174
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 32
- From 14 May 2026 to the primary completion date, Jun 2029
- 11 sites in 5 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- The participant has conditions that preclude a lumbar puncture (LP), such as:
- A history of clinically significant back pain, back pathology, and/or back injury (for example, degenerative disease, spinal deformity, or spinal surgery) that may predispose to complications or technical difficulty with LP.
- Allergy to local anesthetics, such as lidocaine or its derivatives.
- A local infection at the intended site of the LP.
- Less than 100 giga per liter \[(\<100 GI/L) is equivalent to 100,000 per cubic millimeter (100,000/mm³)\] platelets or clinically significant coagulation abnormality or significant active bleeding, or
- Currently receiving treatment with an anticoagulant, antiplatelet agent, or other drug that affects coagulation or platelet function. Low dose (according to local medical guidelines) aspirin is permitted.
Who the study is looking for
- Have completed the main treatment period/phase as well as any off-treatment period/phase of Study OWAA, the parent study for this ISA.
Criteria the registry did not label
- Participants must meet eligibility criteria in the \[L0U-MC-OLMP\] screening protocol before entry into the treatment study.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Not yet recruiting |
| Heritage Medical Research Clinic Coordinator of this site? Confirm its status | Calgary | Canada | Not yet recruiting |
| University Hospital - London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Not yet recruiting |
| McGill University Health Centre Coordinator of this site? Confirm its status | Montreal | Canada | Recruiting |
| Sunnybrook Research Institute Coordinator of this site? Confirm its status | Toronto | Canada | Recruiting |
| Universitätsklinikum Schleswig-Holstein Coordinator of this site? Confirm its status | Lübeck | Germany | Not yet recruiting |
| Universitätsmedizin Rostock Coordinator of this site? Confirm its status | Rostock | Germany | Not yet recruiting |
| Universitaetsklinikum Ulm Coordinator of this site? Confirm its status | Ulm | Germany | Not yet recruiting |
| Hospital Universitari de Bellvitge Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Not yet recruiting |
| Hospital Universitari i Politécnic La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Not yet recruiting |
| Universitair Medisch Centrum Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.