A Master Protocol (OLMP): A Study of LY4256984 in Participants With Amyotrophic Lateral Sclerosis (ALS)

Sponsor
Eli Lilly and Company
Study ID
NCT07571200
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • LY4256984 — DRUG
    Administered IT

Study Details

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.

Key Dates

First listed
May 6, 2026
Start date
May 14, 2026
Status verified
Jul 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: LY4256984
    OL01 Substudy: LY4256984 administered intrathecally (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

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

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