Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ended
Participants planned
72
Countries
2
Sites
2
Obesity with prediabetes or type 2 diabetes mellitus
Key facts
- Sponsor
- Betagenon AB
- Participant type
- Patients, Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 15 Sep 2023 → 7 May 2025
- Decision date (initial)
- 2024-03-19
- 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
Obesity with prediabetes or type 2 diabetes mellitus
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | LLT | 10082306 | Cardiometabolic syndrome | 10027433 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Betagenon AB
- Sponsor organisation
- Betagenon AB
- Address
- Vastra Strandgatan 9b, Umea Stadsfors Umea Stadsfors
- City
- Umea
- Postcode
- 903 26
- Country
- Sweden
Scientific contact point
- Organisation
- Betagenon AB
- Contact name
- Vice President Clinical Development
Public contact point
- Organisation
- Betagenon AB
- Contact name
- Vice President Clinical Development
Locations
2 EU/EEA countries · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Ended | 24 | 1 |
| Netherlands | Ended | 48 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
QPS Netherlands B.V.
Clinical Pharmacology, Hanzeplein 1, 9713 GZ, 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 |
|---|---|---|---|---|---|
| Germany | 2024-03-28 | 2025-05-07 | 2024-03-28 | 2025-05-07 | |
| Netherlands | 2023-09-15 | 2023-12-05 | 2023-09-20 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-07 | Netherlands | Acceptable 2023-09-15
|
2023-09-15 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2023-12-13 | Netherlands | Acceptable 2023-09-15
|
2023-12-13 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2023-12-19 | Acceptable 2023-09-15
|
2024-03-19 | |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-03-27 | Netherlands | Acceptable 2023-09-15
|
2024-03-27 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-17 | Netherlands | Acceptable 2024-08-15
|
2024-08-15 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-23 | Acceptable 2024-10-14
|
2024-10-16 |