Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
80
Countries
1
Sites
1
Obesity
Key facts
- Sponsor
- Resalis Therapeutics S.r.l.
- Participant type
- Healthy volunteers, Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 29 Oct 2024 → 21 Apr 2026
- Decision date (initial)
- 2024-10-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-514871-17-00
- WHO UTN
- U1111-1308-5689
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Obesity
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10029883 | Obesity | 100000004861 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Resalis Therapeutics S.r.l.
- Sponsor organisation
- Resalis Therapeutics S.r.l.
- Address
- Via Ettore De Sonnaz 19
- City
- Turin
- Postcode
- 10121
- Country
- Italy
Scientific contact point
- Organisation
- Resalis Therapeutics S.r.l.
- Contact name
- Almut Nitsche
Public contact point
- Organisation
- Resalis Therapeutics S.r.l.
- Contact name
- Alessandro Toniolo
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 80 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Pharmaceutical Research Associates Group B.V.
Program Management, Van Swietenlaan 6, 9728 NZ, 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 |
|---|---|---|---|---|---|
| Netherlands | 2024-10-29 | 2024-10-29 | 2025-10-01 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-20 | Netherlands | Acceptable with conditions 2024-10-07
|
2024-10-08 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-17 | Netherlands | Acceptable with conditions 2024-10-07
|
2024-10-17 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2024-11-22 | Netherlands | Acceptable with conditions 2024-10-07
|
2024-11-22 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-01-23 | Netherlands | Acceptable with conditions 2024-10-07
|
2025-01-23 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-03-11 | Netherlands | Acceptable with conditions 2024-10-07
|
2025-03-11 |
| 6 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-27 | Netherlands | Acceptable with conditions | 2025-04-09 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2025-04-09 | Netherlands | 2025-04-09 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-04-29 | Netherlands | Acceptable 2025-07-14
|
2025-07-14 |
| 9 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-13 | Netherlands | Acceptable 2025-09-05
|
2025-09-05 |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-6 | 2025-11-14 | Netherlands | Acceptable 2025-09-05
|
2025-11-14 |
| 11 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-05 | Netherlands | Acceptable 2026-02-25
|
2026-02-25 |