Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
33
Countries
1
Sites
1
Normal Hepatic Function and Mild, Moderate, or Severe Hepatic Impairment
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
- 22 Jul 2025 → ongoing
- Decision date (initial)
- 2025-06-16
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-520315-40-00
- WHO UTN
- U1111-1316-8745
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Normal Hepatic Function and Mild, Moderate, or Severe Hepatic Impairment
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.1 | LLT | 10052254 | Hepatic impairment | 10019805 |
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
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ongoing, recruitment ended | 6 | 1 |
| Rest of world
Singapore, United States
|
— | 27 | — |
Investigational sites
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 | 2025-07-22 | 2025-08-11 | 2026-05-13 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-07 | Hungary | Acceptable 2025-06-03
|
2025-06-16 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-13 | Hungary | Acceptable 2025-06-03
|
2026-03-13 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-16 | Hungary | Acceptable 2025-06-03
|
2026-03-16 |