Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
42
Countries
4
Sites
7
Sporadic Amyotrophic Lateral Sclerosis
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nervous System Diseases [C10]
- Trial duration
- 29 Jan 2026 → ongoing
- Decision date (initial)
- 2025-09-04
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2025-521295-60-00
- WHO UTN
- U1111-1321-6118
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Sporadic Amyotrophic Lateral Sclerosis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.1 | PT | 10002026 | Amyotrophic lateral sclerosis | 100000004852 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Eli Lilly & Co.
- Sponsor organisation
- Eli Lilly & Co.
- Address
- 1 Lilly Corporate Center
- City
- Indianapolis
- Postcode
- 46285-0001
- Country
- United States
Scientific contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Eli Lilly & Co.
- Contact name
- Lilly Clinical Trials information desk
Locations
4 EU/EEA countries · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruiting | 5 | 1 |
| Germany | Ongoing, recruiting | 10 | 3 |
| Netherlands | Ongoing, recruiting | 5 | 1 |
| Spain | Ongoing, recruiting | 10 | 2 |
| Rest of world
Canada
|
— | 12 | — |
Investigational sites
Rostock University Medical Center
Klinik und Poliklinik für Neurologie /Sektion für Translationale Neurodegeneration Albrecht Kossel, Gehlsheimer Strasse 20, Gehlsdorf, Rostock
Universitaetsklinikum Ulm AöR
Studienzentrum Neurologie, Oberer Eselsberg 45, Eselsberg, Ulm
Universitaetsklinikum Schleswig-Holstein AöR
Campus Luebeck / Präzisionsneurologie Haus D1, Ratzeburger Allee 160, 23538, Luebeck
Universitair Medisch Centrum Utrecht
Neurology, Heidelberglaan 100, 3584 CX, Utrecht
Hospital Universitario Y Politecnico La Fe
Neurologist, Avenida Fernando Abril Martorell 106, 46026, Valencia
Bellvitge University Hospital
Neurologist, Carrer De La Feixa Llarga S/N, 08907, L'Hospitalet De Llobregat
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Belgium | 2026-02-06 | 2026-02-12 | |||
| Germany | 2026-02-10 | 2026-02-19 | |||
| Netherlands | 2026-01-29 | 2026-02-03 | |||
| Spain | 2026-01-30 | 2026-02-16 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-22 | Germany | Acceptable with conditions 2025-09-02
|
2025-09-02 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-09 | Acceptable with conditions 2025-09-02
|
2025-09-09 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-07 | Germany | Acceptable 2025-11-27
|
2025-11-28 |