A Master Protocol (OLMP): A Study of LY4256984 in Participants With Amyotrophic Lateral Sclerosis… (NCT07571200) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Master Protocol (OLMP): A Study of LY4256984 in Participants With Amyotrophic Lateral Sclerosis (ALS)
Belgium, Canada32 participantsStarted 2026-05
Plain-language 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. 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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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…
What they're measuring
1
Number of Participants Allocated to Each of the Intervention-Specific Appendices (ISA)
Timeframe: Baseline Up to Week 96
Trial details
NCT IDNCT07571200
SponsorEli Lilly and Company
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2029-06
Contact for this trial
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or