Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Temporarily halted
Participants planned
40
Countries
1
Sites
1
Obesity/overweight (healthy subjects)
Key facts
- Sponsor
- Betagenon AB
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 16 Sep 2024 → ongoing
- Decision date (initial)
- 2024-09-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Obesity/overweight (healthy subjects)
| 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
- Thulegatan 1a
- 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
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Germany | Temporarily halted | 40 | 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 | 2024-09-16 | 2024-09-16 | 2025-07-11 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-108014
- Halt date
- 2025-07-11
- Member states concerned
- Germany
- Publication date
- 2025-11-25
- Reason
- Sponsor decision
- Explanation
- A substantial modification might be implemented to continue the trial with another cohort. The decision is pending.
The end of recruitment date has already been notified – however, we missed to also notify as well the temporary halt until the decision if and how to proceed the trial has been taken. Please excuse the oversight. - Follow-up measures
- None; No participants are still under treatment. Only new participants shall be included in a subsequent cohort after authorisation of a substantial modification for the changes to be implemented and to restart the trial.
- Benefit-risk balance changed
- No
- Treatment stopped
- Yes
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-12 | Germany | Acceptable 2024-08-30
|
2024-09-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-01-10 | Germany | Acceptable 2025-02-17
|
2025-02-17 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-03-14 | Germany | Acceptable 2025-02-17
|
2025-03-14 |