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

Overview

Official title

A Master Protocol for Open-Label Extension Studies to Evaluate the Long-Term Safety and Tolerability of Interventions in Various Stages of Clinical Development in Participants With Amyotrophic Lateral Sclerosis

Brief title

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

Registration type

ClinicalTrials.gov

NCT number

NCT07571200

Status

Recruiting

Study category

Interventional, Drug trial

Sponsor / center

Eli Lilly and Company

Research center

Not stated in the official study record.

Collaborators

Not stated in the official study record.

Study type

Interventional study

Phase

Phase 1

Enrollment

32

Start date

05-14-2026

Primary completion date

06-XX-2029

Estimated / actual completion date

06-XX-2029

Last source update

09-22-2026

What is being studied?

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.

Intervention(s)

Who may be eligible?

This is a simplified summary. The official study team or research center determines eligibility.

Population / disease status

Diagnosed ALS

Diagnosis / conditions

Amyotrophic Lateral Sclerosis

Age

18 Years to 80 Years

Disease duration

Not stated in the official study record.

Respiratory criteria

The official eligibility criteria include language relevant to this topic; review the full criteria below.

ALSFRS-R criteria

Not stated in the official study record.

Genetic criteria

Not stated in the official study record.

Medication requirements

Not stated in the official study record.

Major inclusion and exclusion criteria from the official record

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.

Genetics

Gene-specific study?

No

Gene or variant

Any / Not gene-specific

Genetic test required?

Not stated in the official study record.

Known carrier required?

Not stated

Confirmed pathogenic variant required?

Not stated in the official study record.

Presymptomatic carriers eligible?

Not stated in the official study record.

At-risk relative eligible?

Not stated

Genetic test provided?

Not stated in the official study record.

Genetic counseling provided?

Not stated in the official study record.

Results returned / offered?

Not stated

Family history required?

Not stated in the official study record.

Study design

Randomized?

Not stated in the official study record.

Allocation

Not stated in the official study record.

Intervention model

Not stated in the official study record.

Masking

Not stated in the official study record.

Placebo

Not stated in the official study record.

Primary purpose

Not stated in the official study record.

Endpoints

Primary outcome measures

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

Secondary outcome measures

Not stated in the official study record.

A biomarker outcome should not automatically be interpreted as a clinical outcome.

Locations

Contact

Central contact: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · LillyTrials@Lilly.com · 1-317-615-4559; Physicians interested in becoming principal investigators please contact · clinical_inquiry_hub@lilly.com

Study official: 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