Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
40
Countries
1
Sites
1
Healthy volunteers, Impaired renal function and suspected MASH
Key facts
- Sponsor
- ENYO Pharma
- Participant type
- Healthy volunteers
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 28 Oct 2025 → ongoing
- Decision date (initial)
- 2025-10-09
- 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
Healthy volunteers, Impaired renal function and suspected MASH
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
ENYO Pharma
- Sponsor organisation
- ENYO Pharma
- Address
- 60 Avenue Rockefeller
- City
- Lyon
- Postcode
- 69008
- Country
- France
Scientific contact point
- Organisation
- ENYO Pharma
- Contact name
- Head of Clinical Operations
Public contact point
- Organisation
- ENYO Pharma
- Contact name
- Head of Clinical Operations
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 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 |
|---|---|---|---|---|---|
| France | 2025-10-28 | 2025-10-28 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-07-17 | France | Acceptable 2025-10-09
|
2025-10-09 |