Phase 1 Study of LY4256984 Delivered into the Spine to Test Safety and Effects in Adults with Sporadic Amyotrophic Lateral Sclerosis

What this Trial Is About

Researchers are evaluating the safety and tolerance of LY4256984 in people with sporadic amyotrophic lateral sclerosis ALS. This Phase 1 study aims to understand what side effects may occur when LY4256984 is given intrathecally into the spine and how the drug behaves in the body. The study includes adults aged 18 to 75 with a recent ALS diagnosis and a certain body mass index range. Participants will receive multiple ascending doses of LY4256984 or a placebo administered directly into the spine. The study is randomized and double-blinded, meaning participants receive either the drug or placebo without knowing which one. The treatment period lasts up to approximately 253 days, during which dosing and monitoring occur. Throughout the study, researchers will perform blood tests to measure how much LY4256984 reaches the bloodstream and how long it stays there. They will track side effects and serious adverse events related to the treatment from the start until about day 253. Safety assessments include checking cerebrospinal fluid drug levels, monitoring vital signs, and reviewing lumbar spine health. Participants can expect regular evaluations and laboratory tests during their involvement in the trial, which runs from screening through treatment and follow-up.

A Study of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis