Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Authorised, recruitment pending
Participants planned
102
Countries
1
Sites
2
Refractory hyperlipidemia
Key facts
- Sponsor
- Verve Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Decision date (initial)
- 2026-03-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-522617-39-00
- ClinicalTrials.gov
- NCT06451770
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Refractory hyperlipidemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | LLT | 10020667 | Hyperlipidemia | 10027433 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Verve Therapeutics Inc.
- Sponsor organisation
- Verve Therapeutics Inc.
- Address
- 201 Brookline Avenue Suite 601
- City
- Boston
- Postcode
- 02215-4153
- Country
- United States
Scientific contact point
- Organisation
- Verve Therapeutics Inc.
- Contact name
- Clinical Development
Public contact point
- Organisation
- Verve Therapeutics Inc.
- Contact name
- Clinical Development
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 10 | 2 |
| Rest of world
United States, United Kingdom, South Africa, Canada, Australia
|
— | 92 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-11-25 | Netherlands | Acceptable 2026-03-30
|
2026-03-30 |