Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
70
Countries
1
Sites
1
Type 1 Diabetes Mellitus
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 29 Apr 2024 → ongoing
- Decision date (initial)
- 2024-04-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-510365-10-00
- WHO UTN
- U1111-1301-8386
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Type 1 Diabetes Mellitus
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 | 70 | 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 | 2024-04-29 | 2024-05-15 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-26 | Germany | Acceptable 2024-04-19
|
2024-04-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-11-21 | Germany | Acceptable 2025-01-15
|
2025-01-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-03-06 | Germany | Acceptable 2025-03-31
|
2025-04-16 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-05-21 | Germany | Acceptable 2025-06-12
|
2025-06-16 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-23 | Germany | Acceptable 2025-11-13
|
2025-11-14 |