A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis

Lilly

Status and phase: Enrolling; Phase 1

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Drug: LY4256984

Study type: Interventional

Funder types: Industry

Identifiers

NCT07571174

L0U-MC-OLMP (Other Identifier)

2026-525574-19-00 (Other Identifier)

27887

L0U-MC-OL01 (Other Identifier)

Details and patient eligibility

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Participants must meet eligibility criteria in the [L0U-MC-OLMP] screening protocol before entry into the treatment study.

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 1 patient group

LY4256984

Experimental group

Description:

LY4256984 administered intrathecally (IT)

Treatment:

Drug: LY4256984