Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
80
Countries
1
Sites
1
Body weight management
Key facts
- Sponsor
- Camurus AB
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 18 Dec 2024 → 11 Sep 2025
- Decision date (initial)
- 2024-12-10
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Body weight management
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10029883 | Obesity | 100000004861 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Camurus AB
- Sponsor organisation
- Camurus AB
- Address
- Rydbergs Torg 4
- City
- Lund
- Postcode
- 224 84
- Country
- Sweden
Scientific contact point
- Organisation
- Camurus AB
- Contact name
- VP Clinical Development
Public contact point
- Organisation
- Camurus AB
- Contact name
- VP Clinical Development
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 80 | 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 | 2024-12-18 | 2025-09-11 | 2024-12-18 | 2025-05-22 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-16 | Germany | Acceptable 2024-12-06
|
2024-12-10 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-02-14 | Germany | Acceptable 2024-12-06
|
2025-02-14 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-03-07 | Germany | Acceptable 2024-12-06
|
2025-03-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-23 | Germany | Acceptable 2025-05-08
|
2025-05-09 |