Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
30
Countries
1
Sites
1
Overweight
Key facts
- Sponsor
- Boehringer Ingelheim International GmbH
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 5 Sep 2024 → 5 Jan 2026
- Decision date (initial)
- 2024-08-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-512332-29-00
- WHO UTN
- U1111-1307-0132
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Overweight
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Boehringer Ingelheim International GmbH
- Sponsor organisation
- Boehringer Ingelheim International GmbH
- Address
- Binger Strasse 173
- City
- Ingelheim Am Rhein
- Postcode
- 55216
- Country
- Germany
Scientific contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Public contact point
- Organisation
- Boehringer Ingelheim International GmbH
- Contact name
- CT Disclosure & Data Transparency
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 30 | 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 |
|---|---|---|---|---|---|
| Belgium | 2024-09-05 | 2026-01-05 | 2024-10-03 | 2025-04-25 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-26 | Belgium | Acceptable 2024-08-05
|
2024-08-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-02-13 | Belgium | Acceptable 2025-02-27
|
2025-03-04 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-03 | Belgium | Acceptable 2025-04-15
|
2025-04-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-07 | Belgium | Acceptable | 2025-10-23 |