A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis
Recruiting now Phase 1 NCT07571174
Run by Eli Lilly and Company · for 18 to 80 · All sexes
What this study is about
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.
Who can join (things the study team will check)
✅ You may be able to join if…
- Have completed the main treatment period/phase as well as any off-treatment period/phase of Study OWAA, the parent study for this ISA.
🚫 You may not be able to join if…
- 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.
Where this trial is running
- UZ Leuven, Leuven, Belgium
- McGill University Health Centre, Montreal, Canada
- Sunnybrook Research Institute, Toronto, Canada
- Universitätsklinikum Schleswig-Holstein, Lübeck, Germany
- Universitätsmedizin Rostock, Rostock, Germany
- Universitaetsklinikum Ulm, Ulm, Germany
- Universitair Medisch Centrum Utrecht, Utrecht, Netherlands
- Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Spain
- Hospital Universitari i Politecnic La Fe, Valencia, Spain
Who to contact
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · 1-317-615-4559 · LillyTrials@Lilly.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07571174.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.
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