Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
56
Countries
1
Sites
1
Cardiometabolic diseases
Key facts
- Sponsor
- Novo Nordisk A/S
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Male Urogenital Diseases [C12], Diseases [C] - Cardiovascular Diseases [C14], Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 26 Mar 2024 → 17 Feb 2025
- Decision date (initial)
- 2024-03-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-505026-34-00
- WHO UTN
- U1111-1290-1002
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Cardiometabolic diseases
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | LLT | 10082306 | Cardiometabolic syndrome | 10027433 |
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 |
|---|---|---|---|
| Netherlands | Ended | 56 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-03-26 | 2025-02-17 | 2024-03-28 | 2025-02-17 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-01-22 | Netherlands | Acceptable 2024-03-11
|
2024-03-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-03-13 | Netherlands | Acceptable 2024-03-11
|
2024-03-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-07-05 | Netherlands | Acceptable 2024-07-11
|
2024-07-11 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-26 | Netherlands | Acceptable 2024-10-14
|
2024-10-14 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-12-03 | Netherlands | Acceptable 2024-10-14
|
2024-12-03 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-07-03 | Netherlands | Acceptable 2025-07-04
|
2025-07-09 |