Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
136
Countries
1
Sites
2
Adults Living with Overweight and Obesity
Key facts
- Sponsor
- Wave Life Sciences Ireland Limited
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 25 Jul 2025 → ongoing
- Decision date (initial)
- 2025-06-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-520203-41-00
- ClinicalTrials.gov
- NCT06842186
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Adults Living with Overweight and Obesity
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Wave Life Sciences Ireland Limited
- Sponsor organisation
- Wave Life Sciences Ireland Limited
- Address
- One Spencer Dock, Spencer Dock Spencer Dock
- City
- Dublin 1
- Postcode
- D01 X9R7
- Country
- Ireland
Scientific contact point
- Organisation
- Wave Life Sciences Ireland Limited
- Contact name
- Clinical Operations
Public contact point
- Organisation
- Wave Life Sciences Ireland Limited
- Contact name
- Clinical Operations
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Romania | Ongoing, recruiting | 34 | 2 |
| Rest of world
Moldova, Republic of, United Kingdom
|
— | 102 | — |
Investigational sites
Arensia Clinics S.R.L.
Ph. I Unit-ArensiaEM in collab. with Arensia Clinics, 3rd Floor, Wards 1,2,3,4,5,6 and 7, Intrarea Tudor Stefan 38-40, 011658, Bucharest
Spitalul Clinic Judetean De Urgenta Cluj
Ph.I Unit-AEM in collab. with County Emg. Hospital Cluj Ophthalm. build., 1st fl, wrds 33,34,35, Strada Clinicilor 3-5, 400006, Cluj-Napoca
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 |
|---|---|---|---|---|---|
| Romania | 2025-07-25 | 2025-07-25 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-03 | Romania | No conclusion 2025-06-17
|
2025-06-23 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-25 | Romania | No conclusion 2025-06-17
|
2025-06-25 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-04 | Romania | No conclusion 2025-06-17
|
2025-07-04 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-07-24 | Romania | No conclusion 2025-06-17
|
2025-07-24 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-08-29 | Romania | No conclusion 2025-06-17
|
2025-08-29 |