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NCT Number: NCT07571174

A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UZ Leuven, Leuven, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LY4256984

Drug

Administered IT

Primary outcomes

  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: Baseline Up to Week 96

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

3176154559

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Study of Long-Term Safety, Tolerability, and Clinical Outcomes of Intrathecally Administered LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis: A Multicenter, Open-Label, Long-Term Extension of Study J6I-MC-OWAA

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
May 6, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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