NCT07571174 A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis
| NCT ID | NCT07571174 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Eli Lilly and Company |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2026-05-14 |
| Primary Completion | 2029-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 32 participants in total. It began in 2026-05-14 with a primary completion date of 2029-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
✉ LillyTrials@Lilly.com📞 1-317-615-4559
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)
STUDY DIRECTOR
Eli Lilly and Company
Frequently Asked Questions
Who can join the NCT07571174 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Amyotrophic Lateral Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07571174 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07571174 currently recruiting?
Yes, NCT07571174 is actively recruiting participants. Contact the research team at LillyTrials@Lilly.com for enrollment information.
Where is the NCT07571174 trial being conducted?
This trial is being conducted at Leuven, Belgium, London, Canada, Montreal, Canada, Toronto, Canada and 6 additional locations.
Who is sponsoring the NCT07571174 clinical trial?
NCT07571174 is sponsored by Eli Lilly and Company. The principal investigator is 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) at Eli Lilly and Company. The trial plans to enroll 32 participants.
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