Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
132
Countries
1
Sites
1
Healthy, Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 14 May 2025 → ongoing
- Decision date (initial)
- 2025-04-24
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519151-28-00
- WHO UTN
- U1111-1315-8487
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy, Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2
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 |
|---|---|---|---|
| Germany | Ongoing, recruiting | 132 | 1 |
| Rest of world | — | 0 | — |
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 |
|---|---|---|---|---|---|
| Germany | 2025-05-14 | 2025-05-16 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-10 | Germany | Acceptable 2025-04-23
|
2025-04-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-05 | Germany | Acceptable | 2025-07-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-07-16 | Germany | Acceptable 2025-08-07
|
2025-08-12 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-02 | Germany | Acceptable 2026-03-18
|
2026-03-20 |