Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
32
Countries
1
Sites
1
Type 2 Diabetes Mellitus
Key facts
- Sponsor
- Pfizer Inc.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- completed 10 Mar 2025
- Decision date (initial)
- 2024-07-23
- 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
Type 2 Diabetes Mellitus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.1 | PT | 10033307 | Overweight | 100000004861 |
| 20.0 | PT | 10012601 | Diabetes mellitus | 100000004861 |
| 20.0 | PT | 10029883 | Obesity | 100000004861 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pfizer Inc.
- Sponsor organisation
- Pfizer Inc.
- Address
- 66 Hudson Boulevard East
- City
- New York
- Postcode
- 10001-2189
- Country
- United States
Scientific contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Public contact point
- Organisation
- Pfizer Inc.
- Contact name
- Clinical Medical Lead
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 16 | 1 |
| Rest of world
United States
|
— | 16 | — |
Investigational sites
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-12 | Belgium | Acceptable 2024-07-23
|
2024-07-23 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-24 | Belgium | Acceptable 2024-07-23
|
2025-06-24 |