NCT07571200

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. 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1

Timeline
38mo left

Started May 2026

Typical duration for phase_1

Geographic Reach
2 countries

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
May 2026Jun 2029

First Submitted

Initial submission to the registry

April 30, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 6, 2026

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

3.1 years

First QC Date

April 30, 2026

Last Update Submit

April 30, 2026

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

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

    Baseline Up to Week 96

Study Arms (1)

LY4256984

EXPERIMENTAL

OL01 Substudy: LY4256984 administered intrathecally (IT)

Drug: LY4256984

Interventions

LY4256984DRUG

Administered IT

LY4256984

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UZ Leuven

Leuven, 3000, Belgium

Location

McGill University Health Centre

Montreal, H4A 3J1, Canada

Location

Sunnybrook Research Institute

Toronto, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Central Study Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2026

First Posted

May 6, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)BE(1)