Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
21
Countries
1
Sites
2
Metabolism dysfunction
Key facts
- Sponsor
- Adiposs S.A.
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Trial duration
- 10 Mar 2026 → ongoing
- Decision date (initial)
- 2025-05-05
- 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
Metabolism dysfunction
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Adiposs S.A.
- Sponsor organisation
- Adiposs S.A.
- Address
- Route De La Galaise 34
- City
- Plan-Les-Ouates
- Postcode
- 1228
- Country
- Switzerland
Scientific contact point
- Organisation
- Adiposs S.A.
- Contact name
- Nathalie Stransky von Heilkron
Public contact point
- Organisation
- Adiposs S.A.
- Contact name
- Nathalie Stransky von Heilkron
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruiting | 21 | 2 |
| 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 |
|---|---|---|---|---|---|
| Finland | 2025-06-05 | 2025-06-05 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Temporary halts 1 · Art. 38 CTR
Temporary halt TH-96564
- Halt date
- 2025-08-18
- Member states concerned
- Finland
- Publication date
- 2025-09-04
- Reason
- Sponsor decision
- Follow-up measures
- Subjects' follow-up is pursued as per protocol. A protocol amendment will be filed.
- 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 | 2025-02-14 | Finland | Acceptable with conditions 2025-04-29
|
2025-05-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-11-18 | Finland | Acceptable 2026-02-13
|
2026-03-10 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-12 | Finland | Acceptable 2026-02-13
|
2026-03-12 |