🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Germany / NCT07571174
Recruiting Phase 1

A Substudy of LY4256984 in Participants With Sporadic Amyotrophic Lateral Sclerosis

NCT07571174 · tracked via the Priya Life Science Germany 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

The main purpose of this study is to assess the long-term safety and tolerability of LY4256984 in participants with Amyotrophic Lateral Sclerosis (ALS). This study is a long-term extension of study J6I-MC-OWAA (NCT07100119) and is part of the OLMP (NCT07571200) master protocol that will last approximately 96 weeks.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Participants must meet eligibility criteria in the \[L0U-MC-OLMP\] screening protocol before entry into the treatment study. Inclusion Criteria: * Have completed the main treatment period/phase as well as any off-treatment period/phase of Study OWAA, the parent study for this ISA. Exclusion Criteria: * The participant has conditions that preclude a lumbar puncture (LP), such as: * A history of clinically significant back pain, back pathology, and/or back injury (for example, degenerative disease, spinal deformity, or spinal surgery) that may predispose to complications or technical difficulty with LP. * Allergy to local anesthetics, such as lidocaine or its derivatives. * A local infection at the intended site of the LP. * Less than 100 giga per liter \[(\<100 GI/L) is equivalent to 100,000 per cubic millimeter (100,000/mm³)\] platelets or clinically significant coagulation abnormality or significant active bleeding, or * Currently receiving treatment with an anticoagulant, antiplatelet agent, or other drug that affects coagulation or platelet function. Low dose (according to local medical guidelines) aspirin is permitted.

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 Germany

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 NCT07571174 on ClinicalTrials.gov ↗ ← All trials in Germany