Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
16
Countries
1
Sites
1
Not Applicable
Key facts
- Sponsor
- F. Hoffmann-La Roche AG
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Health Care [N] - Population Characteristics [N01]
- Trial duration
- 10 Nov 2025 → 14 Apr 2026
- Decision date (initial)
- 2025-11-07
- 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
Not Applicable
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10029883 | Obesity | 100000004861 |
| 24.1 | PT | 10033307 | Overweight | 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 | Ended | 16 | 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 | 2025-11-10 | 2026-04-14 | 2025-12-08 | 2026-01-22 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-08 | Netherlands | Acceptable 2025-11-07
|
2025-11-07 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-11-13 | Acceptable 2025-11-07
|
||
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-11-13 | Netherlands | 2025-11-13 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-12 | Netherlands | Acceptable 2026-03-20
|
2026-03-20 |