Overview
Sponsor-declared trial summary
Female (aged between 50-70 years (both included)) with obesity (BMI ≥ 30.0 kg/m2) of post-menopausal state at screening (defined as minimum 12 months of amenorrhea and high levels of follicular stimulating hormone (FSH) ≥16 UI/L. In cases of uncertainty, confirmation of postmenopausal status requires low levels of anti-Müllerian hormone (AMH) and inhibin B).
Key facts
- Sponsor
- Novo Nordisk A/S, Steno Diabetes Center Copenhagen
- Participant type
- Healthy volunteers
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 28 May 2025 → ongoing
- Decision date (initial)
- 2025-03-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517883-49-00
- WHO UTN
- U1111-1313-0864
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Female (aged between 50-70 years (both included)) with obesity (BMI ≥ 30.0 kg/m2) of post-menopausal state at screening (defined as minimum 12 months of amenorrhea and high levels of follicular stimulating hormone (FSH) ≥16 UI/L. In cases of uncertainty, confirmation of postmenopausal status requires low levels of anti-Müllerian hormone (AMH) and inhibin B).
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
- EU Submission Hub
Public contact point
- Organisation
- Novo Nordisk A/S
- Contact name
- EU Submission Hub
Steno Diabetes Center Copenhagen
- Sponsor organisation
- Steno Diabetes Center Copenhagen
- Address
- Borgmester Ib Juuls Vej 83
- City
- Herlev
- Postcode
- 2730
- Country
- Denmark
Scientific contact point
- Organisation
- Steno Diabetes Center Copenhagen
- Contact name
- Jonatan Ising Bagger
Public contact point
- Organisation
- Steno Diabetes Center Copenhagen
- Contact name
- Jonatan Ising Bagger
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 144 | 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 |
|---|---|---|---|---|---|
| Denmark | 2025-05-28 | 2025-06-12 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-13 | Denmark | Acceptable 2025-03-18
|
2025-03-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-11 | Denmark | Acceptable 2025-10-17
|
2025-10-17 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-12-17 | Denmark | Acceptable 2025-10-17
|
2025-12-17 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-23 | Denmark | Acceptable 2026-03-23
|
2026-03-27 |