Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
48
Countries
1
Sites
1
Weight management
Key facts
- Sponsor
- Zealand Pharma A/S
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 26 Mar 2025 → 25 Nov 2025
- Decision date (initial)
- 2025-03-14
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518124-77-00
- WHO UTN
- U1111-1314-8088
- ClinicalTrials.gov
- NCT07076030
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Weight management
| 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
Zealand Pharma A/S
- Sponsor organisation
- Zealand Pharma A/S
- Address
- Sydmarken 11
- City
- Soeborg
- Postcode
- 2860
- Country
- Denmark
Scientific contact point
- Organisation
- Zealand Pharma A/S
- Contact name
- Clinical Trial Information Desk
Public contact point
- Organisation
- Zealand Pharma A/S
- Contact name
- Clinical Trial Information Desk
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 48 | 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 | 2025-03-26 | 2025-11-25 | 2025-03-26 | 2025-10-14 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-01-10 | Germany | Acceptable 2025-03-07
|
2025-03-14 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-08 | Germany | Acceptable 2025-03-07
|
2025-07-08 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-10-23 | Germany | Acceptable 2025-03-07
|
2025-10-23 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-11-21 | Germany | Acceptable 2025-03-07
|
2025-11-21 |