Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Authorised, recruitment pending
Participants planned
100
Countries
1
Sites
1
Healthy volunteers
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Phenomena and Processes [G] - Metabolism [G03]
- Decision date (initial)
- 2025-02-19
- 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
Healthy volunteers
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10029883 | Obesity | 100000004861 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
F. Hoffmann-La Roche AG
- Sponsor organisation
- F. Hoffmann-La Roche AG
- Address
- Grenzacherstrasse 124
- City
- Basel
- Postcode
- 4058
- Country
- Switzerland
Scientific contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Public contact point
- Organisation
- F. Hoffmann-La Roche AG
- Contact name
- Trial Information System - TISL
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharma Bio-Research Group
Program Management, Van Swietenlaan 6, 9728 NZ, Groningen
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-13 | Netherlands | Acceptable 2025-02-19
|
2025-02-19 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-06 | Netherlands | Acceptable 2025-02-19
|
2025-03-06 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-18 | Netherlands | Acceptable 2025-10-03
|
2025-10-03 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-01-13 | Netherlands | Acceptable 2026-02-12
|
2026-02-13 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-25 | Netherlands | Acceptable 2026-02-12
|
2026-02-25 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-03-02 | Netherlands | Acceptable 2026-02-12
|
2026-03-02 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-04-13 | Netherlands | Acceptable 2026-02-12
|
2026-04-13 |