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Taking peoplePhase 1

Long-term safety of LY4256984 in people with amyotrophic lateral sclerosis

Checks the long-term safety of LY4256984 in adults with amyotrophic lateral sclerosis.

Key facts

Who runs it
Eli Lilly and Company
Where
Leuven, BelgiumSee the siteAlso in 4 other countries, 10 sites
Registry title
A Master Protocol (OLMP): A Study of LY4256984 in Participants With Amyotrophic Lateral Sclerosis (ALS)
Status
Recruiting
Phase
Phase 1
People taking part
32 people, planned
Started
14 May 2026
Expected to end
Jun 2029
Type of study
Interventional
Treatments tested
  • LY4256984
Record updated
22 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with ALS who finished an earlier ALS treatment study. It checks long-term safety and tolerability of LY4256984 for at least 96 weeks.

Age
18 to 80 years
Sex
All sexes can join.
Disease stage
ALS (sporadic ALS in the OL01 sub study). People with extreme progression in the earlier study, such as permanent mechanical ventilation, may be excluded.
Earlier treatment
Must have finished the main treatment period and any off-treatment period of an earlier ALS study that the sponsor accepts.

Main reasons for not taking part

  • Stopped the study drug in the earlier study, so that restarting would be an unacceptable safety risk
  • Extreme ALS progression in the earlier study, such as permanent mechanical ventilation, that is an unacceptable safety risk
  • An unresolved serious adverse event in the earlier study
  • Another medical illness (not ALS) that rules out continued study drug or study procedures

The registry criteria, word for word

Show all 5 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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

Other criteria

  • Participants must meet eligibility criteria below. Additional criteria are specified in the substudy to which the participant will enroll

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in Belgium

Also in 4 other countries, 10 sites

  • UZ LeuvenLeuven, BelgiumNot yet recruiting

About the trial

What the trial wants to find out

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.

The group in the trial

  • LY4256984Treatment being tested

    OL01 Substudy: LY4256984 administered intrathecally (IT)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
Long-term safety of LY4256984 in people with amyotrophic lateral sclerosisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07571200, who can take part
Record updated
22 September 2026