Long-Term Safety and Tolerability Assessment of LY4256984 Administered Intrathecally in Adults with Amyotrophic Lateral Sclerosis

What this Trial Is About

Researchers are conducting a master protocol study called OLMP to evaluate the safety and tolerability of different treatments for adults with Amyotrophic Lateral Sclerosis ALS. This study includes participants from an earlier study, OWAA, who will be assigned to specific treatment groups such as the Sporadic ALS OL01 substudy. The research aims to monitor treatment effects over at least 96 weeks. Participants in the OL01 substudy receive the investigational drug LY4256984 administered intrathecally directly into the spinal canal. This open-label extension study focuses on long-term safety and tolerability of LY4256984 in adults with ALS. The study is designed as a parallel interventional trial with no masking or placebo control. During the study, participants will be closely monitored for safety and treatment tolerance. The main outcome measured is the number of participants assigned to each intervention-specific appendix over the 96-week period. Participation involves ongoing assessments and follow-ups to track safety and tolerability, with the overall study lasting until June 2029.

A Master Protocol (OLMP): A Study of LY4256984 in Participants With Amyotrophic Lateral Sclerosis (ALS)