Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
37
Countries
1
Sites
1
Healthy postmenopausal females (Type 2 Diabetes)
Key facts
- Sponsor
- Novo Nordisk A/S
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 4 Jul 2024 → 30 Sep 2025
- Decision date (initial)
- 2024-06-27
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-507973-16-00
- WHO UTN
- U1111-1294-3433
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Healthy postmenopausal females (Type 2 Diabetes)
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novo Nordisk A/S
- Sponsor organisation
- Novo Nordisk A/S
- Address
- Novo Alle 1
- City
- Bagsvaerd
- Postcode
- 2880
- Country
- Denmark
Scientific contact point
- Organisation
- Novo Nordisk A/S
- Contact name
- EU Submission Hub
Public contact point
- Organisation
- Novo Nordisk A/S
- Contact name
- EU Submission Hub
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 37 | 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 | 2024-07-04 | 2025-09-30 | 2024-07-18 | 2025-03-06 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-11 | Germany | Acceptable 2024-06-24
|
2024-06-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-02 | Germany | Acceptable 2024-06-24
|
2024-07-02 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-08 | Germany | Acceptable | 2024-08-23 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-09-03 | Germany | Acceptable | 2024-09-03 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2024-10-23 | Germany | Acceptable | 2024-10-23 |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-02-03 | Germany | Acceptable 2025-02-10
|
2025-02-11 |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-25 | Germany | Acceptable 2025-05-16
|
2025-05-19 |
| 8 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-19 | Germany | Acceptable 2025-10-09
|
2025-10-10 |