A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis

Recruiting now · Phase 1

Conditions studied: Amyotrophic Lateral Sclerosis

In brief

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.

Key facts

Study ID

NCT07571174

Run by

Eli Lilly and Company

People needed

32

Starts

2026-05-14

Expected to finish

2029-06-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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 it is running

• McGill University Health Centre — Montreal, Canada (enrolling)
• University Hospital - London Health Sciences Centre — London, 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
• UZ Leuven — Leuven, Belgium
• Hospital Universitari i Politecnic La Fe — Valencia, Spain

Full record on ClinicalTrials.gov

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