Recruiting
Phase 1

LY4256984

Sponsor:

Eli Lilly and Company

Code:

NCT07571174

Conditions

Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

LY4256984

Study Details

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 (NCT07571200) master protocol that will last approximately 96 weeks.

Conditions

Amyotrophic Lateral Sclerosis

Study ID

NCT07571174

Start date

May 14, 2026

Status verified date

Aug, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Jun, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: LY4256984

LY4256984 administered intrathecally (IT)

Interventions

LY4256984

Administered IT

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

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

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

Physicians interested in becoming principal investigators please contact

3176154559clinical_inquiry_hub@lilly.com

Locations

McGill University Health Centre

Recruiting

Montreal, Canada, H4A 3J1

Principal Investigator:

Angela Genge

Sunnybrook Research Institute

Recruiting

Toronto, Canada, M4N 3M5

Principal Investigator:

Agessandro Abrahao

More Information

Sponsor

Eli Lilly and Company

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-08-24.