A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis

NCT07571174 | Not Yet Recruiting Phase 1

• 4 other identifiers: 27887L0U-MC-OL01L0U-MC-OLMP2026-525574-19-00
• Study Type: interventional
• Target: 32
• Locations: 2 countries
• Sites: 3

Brief Summary

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 master protocol that will last approximately 96 weeks.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

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

  Baseline Up to Week 96

Study Arms (1)

LY4256984

EXPERIMENTAL

LY4256984 administered intrathecally (IT)

Drug: LY4256984

Interventions

LY4256984 DRUG

Administered IT

LY4256984

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

UZ Leuven

Leuven, 3000, Belgium

Location

McGill University Health Centre

Montreal, H4A 3J1, Canada

Location

Sunnybrook Research Institute

Toronto, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

3176154559; clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 6, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1); CA (2)