Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
88
Countries
1
Sites
1
Weight management
Key facts
- Sponsor
- Zealand Pharma A/S
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Decision date (initial)
- 2026-06-24
- 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
Weight management
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 | Authorised, recruitment pending | 88 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-04-23 | Germany | Acceptable 2026-06-17
|
2026-06-24 |