Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
50
Countries
2
Sites
2
Healthy, Hepatic Insufficiency
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 19 Nov 2025 → ongoing
- Decision date (initial)
- 2025-10-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy, Hepatic Insufficiency
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
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ongoing, recruiting | 14 | 1 |
| Slovakia | Ongoing, recruiting | 12 | 1 |
| Rest of world
New Zealand
|
— | 24 | — |
Investigational sites
Summit Clinical Research s.r.o.
Department of Internal Medicine and Clinical Pharmacology, Nove Mesto, Bardosova 2a, Bratislava
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 |
|---|---|---|---|---|---|
| Hungary | 2025-11-19 | 2025-11-20 | |||
| Slovakia | 2025-11-19 | 2025-11-20 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-06-30 | Slovakia | Acceptable 2025-10-17
|
2025-10-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-14 | Slovakia | Acceptable 2026-01-28
|
2026-01-30 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-24 | Acceptable 2026-01-28
|
2026-03-24 |