Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruiting
Participants planned
14
Countries
1
Sites
1
transthyretin amyloid amyloidosis cardiomyopathy (ATTR-CM)
Key facts
- Sponsor
- Novo Nordisk A/S
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 12 Feb 2026 → ongoing
- Decision date (initial)
- 2025-07-01
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519372-22-00
- WHO UTN
- U1111-1316-9198
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
transthyretin amyloid amyloidosis cardiomyopathy (ATTR-CM)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 25.1 | LLT | 10087837 | Transthyretin amyloid cardiomyopathy | 100000004848 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novo Nordisk A/S
- Sponsor organisation
- Novo Nordisk A/S
- Address
- Novo Alle 1
- City
- Bagsvaerd
- Postcode
- 2880
- Country
- Denmark
Scientific contact point
- Organisation
- Novo Nordisk A/S
- Contact name
- Michael Soliman, MD
Public contact point
- Organisation
- Novo Nordisk A/S
- Contact name
- Michael Soliman, MD
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 14 | 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 | 2026-02-12 | 2026-03-02 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-05 | Netherlands | Acceptable 2025-06-25
|
2025-07-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-10-02 | Netherlands | Acceptable 2025-10-21
|
2025-10-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-10 | Netherlands | Acceptable | 2026-02-20 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-06 | Netherlands | Acceptable | 2026-03-06 |