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Clinical Trials in Canada / NCT07571200
Recruiting Phase 1

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

NCT07571200 · tracked via the Priya Life Science Canada tracker
Phase
Phase 1
Started
2026-05-14
Last updated
2026-09-22

Condition(s) studied

Amyotrophic Lateral Sclerosis

Investigational drug(s) / intervention(s)

LY4256984 →

LY4256984: Administered IT

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
UZ Leuven Leuven Belgium Not Yet Recruiting
Heritage Medical Research Clinic Calgary Canada Not Yet Recruiting
University Hospital - London Health Sciences Centre London Canada Not Yet Recruiting
McGill University Health Centre Montreal Canada Recruiting
Sunnybrook Research Institute Toronto Canada Recruiting
Universitätsklinikum Schleswig-Holstein Lübeck Germany Not Yet Recruiting
Universitätsmedizin Rostock Rostock Germany Not Yet Recruiting
Universitaetsklinikum Ulm Ulm Germany Not Yet Recruiting
Universitair Medisch Centrum Utrecht Utrecht Netherlands Not Yet Recruiting
Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Spain Not Yet Recruiting
Hospital Universitari i Politecnic La Fe Valencia Spain Not Yet Recruiting

More Eli Lilly and Company trials in Canada

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07571200 on ClinicalTrials.gov ↗ ← All trials in Canada