Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
42
Countries
1
Sites
1
Obesity and Diabetes mellitus Typ 2
Key facts
- Sponsor
- Novo Nordisk A/S
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 18 Jul 2024 → 24 Feb 2025
- Decision date (initial)
- 2024-06-25
- 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
Obesity and Diabetes mellitus Typ 2
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10067585 | Type 2 diabetes mellitus | 100000004861 |
| 20.0 | PT | 10029883 | Obesity | 100000004861 |
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 | 42 | 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 | 2024-07-18 | 2025-02-24 | 2024-07-18 | 2025-02-24 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-26 | Germany | Acceptable 2024-06-06
|
2024-06-25 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-07-12 | Germany | Acceptable 2024-06-06
|
2024-07-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-17 | Germany | Acceptable 2024-08-08
|
2024-08-09 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-16 | Germany | Acceptable 2025-06-06
|
2025-06-12 |