A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis

ConditionAmyotrophic Lateral Sclerosis

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-80

SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

Qualifiers

Have completed the main treatment period/phase as well as any off-treatment period/phase of Study OWAA, the parent study for this ISA.

Disqualifiers

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