Recruiting
Phase 1

Sporadic Amyotrophic Lateral Sclerosis

Sponsor:

Eli Lilly and Company

Code:

NCT07571200

Conditions

Amyotrophic Lateral Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

LY4256984

Study Details

Brief summary:

Study OLMP is a master protocol that will support a collection of individual sub studies that share key design components. Participants from the originator study OWAA (NCT07100119) will be assigned to the appropriate study treatment group: Sporadic Amyotrophic Lateral Sclerosis OL01 (NCT07571174). The studies aim to evaluate the safety and tolerability of different treatments in participants with Amyotrophic Lateral Sclerosis (ALS) that will last at least 96 weeks.

Conditions

Amyotrophic Lateral Sclerosis

Study ID

NCT07571200

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 below. Additional criteria are specified in the substudy to which the participant will enroll.

Inclusion Criteria:

  • Have completed an eligible parent study, as determined by the investigator. Eligible parent studies will be defined by the sponsor but will be clinical studies designed to evaluate a study intervention for the treatment of ALS.

  • Note 1: To be considered a "completer" of a parent study, the participant must finish the main treatment period/phase of the parent study as well as any off-treatment period/phase as described in the parent study's protocol.
  • Note 2: Visits missed in a parent study will have no impact on the completer status of a potential participant.

Exclusion Criteria:

  • During the parent study, the participant permanently or temporarily discontinued the investigational medicinal product (IMP), such that restarting the IMP would pose an unacceptable risk to the participant's safety, in the opinion of the investigator.
  • During the parent study, the participant experienced extreme ALS disease progression (for example, permanent mechanical ventilation) that poses an unacceptable risk to the participant's safety in the opinion of the investigator.
  • During the parent study, the participant developed an unresolved SAE or a medical illness (other than ALS) that, in the opinion of the investigator, precludes either continued exposure to an IMP or participation in study procedures due to an unacceptable risk to the participant's safety.

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: LY4256984

OL01 Substudy: LY4256984 administered intrathecally (IT)

Interventions

LY4256984

Administered IT

Primary outcome measure

  • Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA) [ 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

clinical_inquiry_hub@lilly.com

Locations

McGill University Health Centre

Recruiting

Montreal, Canada, H4A 3J1

Contacts

(514) 398-8588

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.