Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
1,200
Countries
18
Sites
104
Non-alcoholic steatohepatitis (NASH)
Part 1 To demonstrate that treatment with semaglutide s.c. improves liver histology compared to placebo in subjects with NASH and fibrosis stage 2 or 3. Part 2 To demonstrate that treatment with semaglutide s.c. lowers the risk of liver-related clinical events compared to placebo in subjects with NASH and fibrosis stag…
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] - Digestive System Diseases [C06]
- Trial duration
- 29 Mar 2021 → ongoing
- Decision date (initial)
- 2024-06-24
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Novo Nordisk A/S
External identifiers
- EU CT number
- 2023-506962-30-00
- EudraCT number
- 2019-004594-44
- WHO UTN
- U1111-1244-3678
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Part 1 To demonstrate that treatment with semaglutide s.c. improves liver histology compared
to placebo in subjects with NASH and fibrosis stage 2 or 3.
Part 2 To demonstrate that treatment with semaglutide s.c. lowers the risk of liver-related
clinical events compared to placebo in subjects with NASH and fibrosis stage 2 or 3.
Secondary objectives 4
- To demonstrate that treatment with semaglutide s.c. lowers body weight compared to placebo in subjects with NASH and fibrosis stages 2 or 3.
- To demonstrate that treatment with semaglutide s.c. improves patient-reported outcomes compared to placebo in subjects with NASH and fibrosis stages 2 or 3.
- To compare the effects of semaglutide s.c. versus placebo on cardiovascular disease and cardio-metabolic factors in subjects with NASH and fibrosis stages 2 or 3.
- To compare the effect of semaglutide s.c. versus placebo on biomarkers related to fibrosis in subjects with NASH and fibrosis stages 2 or 3.
Conditions and MedDRA coding
Non-alcoholic steatohepatitis (NASH)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 24.1 | PT | 10053219 | Non-alcoholic steatohepatitis | 100000004871 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration, European Medicines Agency, Federal Institute For Drugs And Medical Devices, National Medical Products Administration, Pharmaceuticals And Medical Devices Agency
- EMA paediatric investigation plan (PIP)
- EMEA-001441-PIP05-20
- Plan to share IPD
- No
- IPD plan description
- NA
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Age above or equal to 18 years at the time of signing informed consent.
- Histological evidence of NASH based on a central pathologist evaluation of the baseline liver biopsy. The baseline liver biopsy can be a historical biopsy obtained within 180 days prior to the screening visit (V1).
- Histological evidence of fibrosis stage 2 or stage 3 according to the NASH CRN classification based on a central pathologist evaluation of the baseline liver biopsy.
- A histological NAS ≥ 4 with a score of 1 or more in steatosis, lobular inflammation and hepatocyte ballooning based on a central pathologist evaluation of the baseline liver biopsy.
Exclusion criteria 7
- Documented causes of chronic liver disease other than non-alcoholic fatty liver disease (NAFLD)
- Positive HBsAg, positive anti-HIV, positive HCV RNA at screening (V2A) or any known presence of HCV RNA or HBsAg within 2 years of screening (V2A).
- Presence or history of ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis or liver transplantation at randomisation.
- Known or suspected excessive consumption of alcohol (> 20 g/day for women or > 30 g/day for men) or alcohol dependence (assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)).
- Treatment with vitamin E (at doses ≥800 IU/day) or pioglitazone or medications approved for treatment of NASH which has not been at a stable dose in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose from time of biopsy until screening.
- Treatment with GLP-1 RAs in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, any treatment with GLP-1 RAs from time of biopsy until screening (V2A).
- Treatment with glucose-lowering agent(s) (other than GLP-1 RAs), lipid-lowering medication or weight loss medication not stable in the opinion of the investigator in the period from 90 days prior to the screening visit (V2A). In addition, for subjects with historical liver biopsies taken more than 90 days prior to screening, treatment should be at a stable dose in the opinion of the investigator from time of biopsy until screening.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Part 1 Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No) from randomisation (week 0) to week 72
- Part 1 Improvement in liver fibrosis and no worsening of steatohepatitis (Yes/No) from randomisation (week 0) to week 72
- Part 2 Cirrhosis-free survival (Yes/No) from randomisation (week 0) to week 240
Secondary endpoints 35
- Change in body weight from randomisation (week 0) to week 72
- Resolution of steatohepatitis and improvement in liver fibrosis (Yes/No) from randomisation (week 0) to week 72
- Change in SF-36 Bodily Pain from randomisation (week 0) to week 72
- Change in body weight from randomisation (week 0) to week 240
- Improvement in steatohepatitis with at least a 2-point reduction in NAS and no worsening of fibrosis (Yes/No) from randomisation (week 0) to week 72
- Change in histology-assessed liver collagen proportionate area from randomisation (week 0) to week 72
- Worsening in steatohepatitis (Yes/No) from randomisation (week 0) to week 72
- Improvement in histology-assessed ballooning (Yes/No) from randomisation (week 0) to week 72
- Improvement in histology-assessed inflammation (Yes/No) from randomisation (week 0) to week 72
- Improvement in histology-assessed steatosis (Yes/No) from randomisation (week 0) to week 72
- NASH resolution (ballooning of 0, inflammation of 0-1) and ≥2point NAS reduction with no worsening of fibrosis from randomisation (week 0) to week 72
- Progression of liver fibrosis in patients with F2 at baseline (Yes/No) from randomisation (week 0) to week 72
- Progression of liver fibrosis from randomisation (week 0) to week 72
- Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No) from randomisation (week 0) to week 240
- Improvement in liver fibrosis and no worsening of steatohepatitis (Yes/No) from randomisation (week 0) to week 240
- Changes in liver stiffness values assessed by transient elastography (FibroScan®) from randomisation (week 0) to week 72 and week 240
- Change in ELF score from randomisation (week 0) to week 72 and week 240
- Change in ALT from randomisation (week 0) to week 72 and week 240
- Change in AST from randomisation (week 0) to week 72 and week 240
- Change in CAP values assessed by transient elastography (FibroScan) from randomisation (week 0) to week 72 and week 240
- Change in FAST score from randomisation (week 0) to week 72 and week 240
- Change in Pro-C3 from randomisation (week 0) to week 72 and week 240
- Change in inflammation assessed by hsCRP from randomisation (week 0) to week 72 and week 240
- Change in HbA1c from randomisation (week 0) to week 72 and week 240
- Change in triglyceride from randomisation (week 0) to week 72 and week 240
- Change in free fatty acids from randomisation (week 0) to week 72 and week 240
- Change in LDL cholesterol from randomisation (week 0) to week 72 and week 240
- Change in HDL cholesterol from randomisation (week 0) to week 72 and week 240
- Time to first MACE (composite endpoint) from randomisation (week 0) to week 240
- Major cardio-hepatic event-free survival (Yes/No) from randomisation (week 0) to week 240
- Changes in SF-36 Physical Component Summary from randomisation (week 0) to week 72 and week 240
- Changes in SF-36 Mental Component Summary from randomisation (week 0) to week 72 and week 240
- Change in SF-36 Bodily Pain from randomisation (week 0) to week 240
- Changes in NASH-CHECK Abdominal Pain from randomisation (week 0) to week 72 and week 240
- Absence of histological evidence of NASH (Yes/No) from randomisation (week 0) to week 240
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 16
Semaglutide D 3.2 mg/mL DV3396
PRD7416615 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 241 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
Semaglutide D 1.0 mg/mL DV3396
PRD7416612 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 241 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
Semaglutide D 2.27 mg/mL DV3396
PRD7416614 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 241 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
Semaglutide D 2.0 mg/mL DV3396
PRD7416613 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 241 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
Semaglutide D 0.5 mg/mL DV3396
PRD7416611 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 241 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
Semaglutide B 2.27 mg/mL PDS290 3.0 mL
PRD9597543 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 241 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
Semaglutide B 1.34 mg/mL PDS290 1.5 mL
PRD9597546 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 241 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
Semaglutide B 1.34 mg/mL PDS290 3.0 mL
PRD9597544 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 241 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
Semaglutide B 3.2 mg/mL PDS290 3.0 mL
PRD9597545 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 241 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
Semaglutide B 0.68 mg/mL PDS290 1.5 mL
PRD9597542 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 00 mg milligram(s)
- Max total dose
- 00 mg milligram(s)
- Max treatment duration
- 241 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
Wegovy 2.4 mg FlexTouch solution for injection in pre-filled pen
PRD9862213 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 241 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/21/1608/010
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Wegovy 1 mg solution for injection in pre-filled pen
PRD9446837 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 241 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/21/1608/003
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Wegovy 1.7 mg solution for injection in pre-filled pen
PRD9446838 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 241 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/21/1608/004
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Wegovy 0.5 mg solution for injection in pre-filled pen
PRD9446836 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 241 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/21/1608/002
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Wegovy 2.4 mg solution for injection in pre-filled pen
PRD9446839 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 241 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/21/1608/005
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Wegovy 0.25 mg solution for injection in pre-filled pen
PRD9446835 · Product
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 241 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/21/1608/001
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 2
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
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
Third parties 14
| Organisation | City, country | Duties |
|---|---|---|
| Hannover Medical School ORL-000005657
|
Hannover, Germany | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Perceptive Eclinical Limited ORG-100041144
|
Nottingham, United Kingdom | Other |
| Vivos Technology Limited ORG-100041363
|
London, United Kingdom | Code 10 |
| Celerion Switzerland AG ORG-100013062
|
Fehraltorf, Switzerland | Other |
| Signant Health Management Limited ORG-100040504
|
Reading, United Kingdom | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Laboratory analysis |
| Oracle Danmark ApS ORG-100044663
|
Hellerup, Denmark | Other |
| Bioiatriki Private Medical Polyclinic S.A. ORG-100047061
|
Athens, Greece | Other |
| Pathai Inc. ORG-100031209
|
Boston, United States | Other |
| Stoelting ORL-000005879
|
IL, United States | Other |
| MARKEN Germany GmbH ORG-100017196
|
Kelsterbach, Germany | Other |
| Abbott GmbH ORG-100000219
|
Wiesbaden, Germany | Other |
Locations
18 EU/EEA countries · 104 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 10 | 3 |
| Belgium | Ongoing, recruitment ended | 12 | 6 |
| Bulgaria | Ongoing, recruitment ended | 11 | 2 |
| Croatia | Ended | 2 | 3 |
| Czechia | Ongoing, recruitment ended | 8 | 3 |
| Denmark | Ongoing, recruitment ended | 15 | 4 |
| France | Ongoing, recruitment ended | 19 | 10 |
| Germany | Ongoing, recruitment ended | 17 | 9 |
| Greece | Ongoing, recruitment ended | 14 | 4 |
| Ireland | Ongoing, recruitment ended | 5 | 2 |
| Italy | Ongoing, recruitment ended | 24 | 10 |
| Netherlands | Ongoing, recruitment ended | 10 | 3 |
| Norway | Ongoing, recruitment ended | 9 | 2 |
| Poland | Ongoing, recruitment ended | 11 | 6 |
| Portugal | Ongoing, recruitment ended | 19 | 14 |
| Romania | Ongoing, recruitment ended | 4 | 10 |
| Slovakia | Ongoing, recruitment ended | 6 | 5 |
| Spain | Ongoing, recruitment ended | 23 | 8 |
| Rest of world
Singapore, Taiwan, Brazil, India, United Kingdom, Mexico, Japan, Canada, Malaysia, South Africa, Switzerland, Turkey, Korea, Democratic People's Republic of, China, Serbia, Israel, Argentina, Russian Federation, Australia, United States
|
— | 981 | — |
Investigational sites
Ordination Dr. Evelyn Fliesser-Görzer
N/A, Kastaniensiedlung 1, 8511, St. Stefan ob Stainz
University Hospital Graz
N/A, Auenbruggerplatz 52, 8036, Graz
Klinik Landstrabe
N/A, Juchgasse 25, Landstrasse, Vienna
Universitair Ziekenhuis Gent
N/A, Corneel Heymanslaan 10, 9000, Gent
Az Maria Middelares Gent
N/A, Buitenring-Sint-Denijs 30, 9000, Gent
Ziekenhuis Oost Limburg
N/A, Synaps Park 1, 3600, Genk
Antwerp University Hospital
N/A, Drie Eikenstraat 655, 2650, Edegem
Cliniques Universitaires Saint-Luc
N/A, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Hopital Erasme
N/A, Lennikse Baan 808, 1070, Anderlecht
Acibadem City Clinic Tokuda University Hospital EAD
Department of Gastroenterology, Bulevard Nikola Yonkov Vaptsarov 51b, 1407, Sofiya
Diagnostic Consultation Center XX-Sofia EOOD
Gastroenterology Consulting Room, Ulitsa Gen. Stefan Toshev 15, 1618, Sofia
KBC Split
N/A, Spinciceva 1, 21000, Split
Clinical Hospital Dubrava
N/A, Avenija Gojka Suska 6, Zagreb, Grad Zagreb
Klinicki Bolnicki Centar Osijek
N/A, Ulica Josipa Huttlera 4, 31000, Osijek
Research Site s.r.o.
N/A, Sumavska 163/2, Vychodni Predmesti, Plzen 3
Vseobecna Fakultni Nemocnice V Praze
N/A, U Nemocnice 499/2, Nove Mesto, Prague
Krajska nemocnice Liberec a.s.
N/A, Husova 357/10, Liberec I-Stare Mesto, Liberec (neclenene Mesto)
Odense University Hospital
N/A, J B Winsloews Vej 4, 5000, Odense C
Region Hovedstaden
N/A, Bispebjerg Bakke 23, 2400, Copenhagen Nv
Aarhus Universitetshospital
N/A, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Hvidovre Hospital
N/A, Kettegaard Alle 30, 2650, Hvidovre
Assistance Publique Hopitaux De Paris
N/A, 100 Boulevard Du General Leclerc, 92110, Clichy
Hospices Civils De Lyon
N/A, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Centre Hospitalier Universitaire De Nice
N/A, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire De Bordeaux
N/A, Avenue De Magellan, 33600, Pessac
Assistance Publique Hopitaux De Paris
N/A, 43 Boulevard De L Hopital, 75013, Paris
Assistance Publique Hopitaux De Paris
N/A, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
Centre Hospitalier Universitaire De Lille
N/A, Rue Michel Polonowski, 59000, Lille
Centre Hospitalier Universitaire D'Angers
N/A, 4 Rue Larrey, 49100, Angers
Les Hopitaux Universitaires De Strasbourg
N/A, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
Hospices Civils De Lyon
N/A, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH
N/A, In Der Schornau 23-25, Langendreer, Bochum
Universitat Heidelberg
N/A, Theodor-Kutzer-Ufer 1-3, Wohlgelegen, Mannheim
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
N/A, Langenbeckstrasse 1, Oberstadt, Mainz
Goethe University Frankfurt
N/A, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Eugastro GmbH
N/A, Johannisplatz 1, Zentrum Sudost, Leipzig
Medizinische Hochschule Hannover
N/A, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Charite Universitaetsmedizin Berlin KöR
N/A, Augustenburger Platz 1, Wedding, Berlin
University Of Luebeck
N/A, Ratzeburger Allee 160, Strecknitz, Luebeck
Universitaetsklinikum Leipzig AöR
N/A, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Ippokratio General Hospital Of Thessaloniki
D’ Clinic of Internal Medicine – Gastroenterology department, Konstadinoupoleos 49, 546 42, Thessaloniki
Laiko General Hospital Of Athens
Gastroenterology Clinic, Agiou Thoma (goudi) 17, 115 27, Athens
University General Hospital Of Thessaloniki Ahepa
1st Department of Internal Medicine, 1st St Kiriakidis Str, 546 36, Thessaloniki
Laiko General Hospital Of Athens
1st Propapeudic Department of Internal Medicine - Clinic of Endocrinology, Diabetes, Metabolism, Agiou Thoma (goudi) 17, 115 27, Athens
St James's Hospital
N/A, James's Street, D08 NHY1, Dublin 8
Beaumont Hospital
N/A, Beaumont Road, Beaumont, Dublin 9
Azienda Ospedaliero Universitaria Ospedali Riuniti
N/A, Viale Luigi Pinto 1, 71122, Foggia
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
N/A, Corso Bramante 88, 10126, Turin
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
N/A, Via Pietro Albertoni 15, 40138, Bologna
Casa Sollievo Della Sofferenza
N/A, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
Universita' Campus Bio-medico Di Roma
N/A, Via Alvaro Del Portillo 200, 00128, Rome
Careggi University Hospital
N/A, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliero Universitaria Renato Dulbecco
N/A, Viale Europa, 88100, Catanzaro
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
N/A, Via Del Vespro 129, 90127, Palermo
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
N/A, Largo Francesco Vito 1, 00168, Rome
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
N/A, Via Francesco Sforza 35, 20122, Milan
Sint Franciscus Vlietland Groep Stichting
N/A, Kleiweg 500, 3045 PM, Rotterdam
Academisch Medisch Centrum
N/A, Meibergdreef 9, 1105 AZ, Amsterdam
Noordwest Ziekenhuisgroep Stichting
N/A, Wilhelminalaan 12, 1815 JD, Alkmaar
Baerum Sykehus
N/A, Sogneprest Munthe-Kaas Vei 100, 1346, Gjettum
Oslo University Hospital HF
N/A, Taarnbygget, Kirkeveien 166, Oslo
ID Clinic Arkadiusz Pisula
N/A, Ul. Janowska 19, 41-400, Myslowice
Centrum Medyczne Gizinscy Sp. z o.o.
N/A, Ul. Lesna 9a, 85-676, Bydgoszcz
Futuremeds Sp. z o.o.
N/A, Ul. Legnicka 16, 53-673, Wroclaw
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
N/A, Ul. Ul. Jana Dlugosza 4, 51-162, Wroclaw
Bodyclinic Sp. z o.o. sp.k.
N/A, Ul. Ulica Jozefa Sierakowskiego 4/u3, 03-712, Warsaw
Velocity Nova Sp. z o.o.
N/A, Ul. 11 Listopada 78, 28-200, Staszow
Centro Hospitalar De Vila Nova De Gaia/Espinho E.P.E.
N/A, Rua Conceicao Fernandes S/n, 4434-502, Vila Nova De Gaia
Unidade Local De Saude De Santa Maria E.P.E.
N/A, Avenida Professor Egas Moniz, 1649-035, Lisbon
Unidade Local De Saude Da Guarda E.P.E.
N/A, Avenida Rainha Dona Amelia 19, 6300-749, Guarda
Centro Hospitalar Do Baixo Vouga E.P.E. (CHBV E.P.E.)
N/A, Avenida De Artur Ravara, 3814-501, Aveiro
Hospital Da Luz Arrabida S.A.
N/A, Praceta Henrique Moreira 150, 4400-346, Vila Nova De Gaia
Unidade Local De Saude De Tras-Os-Montes E Alto Douro
N/A, Ulstmad, Avenida Da Noruega, Vila Real
CCAB Centro Clinico Academico Braga Associacao
N/A, Lugar De Sete Fontes S Victor, 4710-243, Braga
Unidade Local De Saude Do Alto Minho E.P.E.
N/A, Estrada De Santa Luzia, 4904-858, Viana Do Castelo
Unidade Local De Saude De Santo Antonio E.P.E.
N/A, Largo Professor Abel Salazar, 4050-011, Porto
Unidade Local De Saude Do Alto Ave E.P.E.
N/A, Rua Dos Cuteleiros De Guimaraes, 4835-044, Guimaraes
Unidade Local De Saude De Matosinhos E.P.E.
N/A, Rua Doutor Eduardo Torres, 4464-513, Senhora Da Hora
Centro Hospitalar Universitario Sao Joao E.P.E.
N/A, Alameda Professor Hernani Monteiro, 4200-319, Porto
APDP Associacao Protectora Dos Diabeticos De Portugal
N/A, Rua Rodrigo Da Fonseca 1, 1250-189, Lisbon
Unidade Local De Saude De Almada-Seixal E.P.E.
N/A, Avenida Torrado Da Silva, 2805-267, Almada
Spital Judetean De Urgenta Satu Mare
Gastroenterologie, Piata Eroilor Revolutiei 1-2, 440055, Satu Mare
Institutul Clinic Fundeni
Gastroenterologie 3, Soseaua Fundeni 258, 022328, Bucharest
Sana Monitoring S.R.L.
Gastroenterologie, Strada Dr. Dumitru Sergiu Nr. 3, 011025, Bucharest
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj
Gastroenterologie 3, Strada Croitorilor 19-21, 400162, Cluj-Napoca
Hightech Medical Services S.R.L.
Diabet, Sector 1 Alexandra Ioan Cuza Blvd 76, 011053, Bucharest
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
Gastroenterologie, Bulevardul Tomis Nr 145, 900591, Constanta
Gastromedica S.R.L.
Gastroenterologie, Strada Ibraileanu Garabet 4b, 700506, Jassi
CF Clinical Hospital
Gastroenterologie, Strada Republicii 18, 400015, Cluj-Napoca
Institutul Clinic Fundeni
Gastroenterologie 2, Soseaua Fundeni 258, 022328, Bucharest
Diamed Obesity S.R.L.
Diabet, Gheorghe Doja Nr 73, 800291, Galati
Univerzitna nemocnica L. Pasteura Kosice
II. Interna klinika, Trieda Snp 1, Zapad, Kosice - Zapad
Medispektrum s.r.o.
Ambulancia diabetologie a poruch latkovej premeny a vyzivy, Gercenova 4/a, 851 01, Petrzalka
JAL s.r.o.
Ambulancia diabetologie a poruch latkovej premeny a vyzivy, Trhova 4, 917 01, Trnava
University Hospital Bratislava
Ambulancia diabetologie a poruch latkovej premeny a vyzivy, Limbova 5, Nove Mesto, Bratislava
Nemocnica s poliklinikou Stefana Kukuru Michalovce a.s.
Hepatobiliarne centrum, Spitalska 2, 071 01, Michalovce
University Hospital Virgen Del Rocio S.L.
N/A, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Clinico Universitario De Valladolid
N/A, Avenida Ramon Y Cajal 3, 47003, Valladolid
Hospital Universitario Marques De Valdecilla
N/A, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario Y Politecnico La Fe
N/A, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Complexo Hospitalario Universitario De Pontevedra
N/A, Calle Mourente S/n, 36164, Pontevedra
Hospital Universitario Puerta De Hierro De Majadahonda
N/A, Calle De Manuel De Falla 1, 28222, Majadahonda
Vall D'hebron Institut De Recerca
N/A, Passeig De La Vall D'hebron 119-129, 08035, Barcelona
Hospital General Universitario De Valencia
N/A, Avenida Del Tres Cruces 2, 46014, Valencia
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 |
|---|---|---|---|---|---|
| Austria | 2021-03-31 | 2021-04-01 | 2024-05-17 | ||
| Belgium | 2021-04-02 | 2021-04-26 | 2024-06-25 | ||
| Bulgaria | 2021-04-29 | 2021-05-10 | 2024-04-26 | ||
| Croatia | 2021-09-21 | 2026-03-12 | 2021-09-30 | 2023-05-25 | |
| Czechia | 2021-03-31 | 2021-04-01 | 2024-07-29 | ||
| Denmark | 2021-04-15 | 2021-05-06 | 2024-07-31 | ||
| France | 2021-07-22 | 2021-07-27 | 2024-07-09 | ||
| Germany | 2021-05-26 | 2021-06-07 | 2024-06-20 | ||
| Greece | 2021-03-31 | 2021-04-07 | 2024-03-21 | ||
| Ireland | 2021-09-21 | 2021-09-22 | 2025-11-06 | ||
| Italy | 2021-03-31 | 2021-04-01 | 2024-07-04 | ||
| Netherlands | 2021-03-29 | 2021-04-01 | 2022-02-16 | ||
| Norway | 2021-07-20 | 2021-09-22 | 2024-01-31 | ||
| Poland | 2021-03-29 | 2021-04-01 | 2024-06-19 | ||
| Portugal | 2021-05-06 | 2021-06-14 | 2024-07-24 | ||
| Romania | 2022-03-16 | 2022-03-28 | 2024-07-31 | ||
| Slovakia | 2021-06-02 | 2021-07-23 | 2024-03-19 | ||
| Spain | 2021-04-19 | 2021-04-22 | 2024-06-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 146 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_NN9931-4553_Protocol EU CT 2023-506962-30_ ENG-For publication | 17 |
| Protocol (for publication) | D1_NN9931-4553_Protocol EU CT 2023-506962-30_GR-For publication | 17 |
| Protocol (for publication) | Patient facing material with copyright_blank document-For Publication | 1 |
| Recruitment arrangements (for publication) | Transition statement - for publication | 1 |
| Recruitment arrangements (for publication) | Transition statement - for publication | 1 |
| Recruitment arrangements (for publication) | Transition statement - for publication | 1 |
| Recruitment arrangements (for publication) | Transition statement - for publication | 1 |
| Recruitment arrangements (for publication) | Transition statement - for publication | 1 |
| Recruitment arrangements (for publication) | Transition statement - For publication | 1 |
| Recruitment arrangements (for publication) | Transition statement - for publication | 1 |
| Recruitment arrangements (for publication) | Transition statement - for publication | 1 |
| Recruitment arrangements (for publication) | Transition statement - for publication | 1 |
| Recruitment arrangements (for publication) | Transition statement - for publication | 1 |
| Recruitment arrangements (for publication) | Transition statement - for publication | 1 |
| Recruitment arrangements (for publication) | Transition statement - For publication | 1 |
| Recruitment arrangements (for publication) | Transition statement -For publication | 1 |
| Recruitment arrangements (for publication) | Transition statement -For publication | 1 |
| Recruitment arrangements (for publication) | Transition statement -For publication | 1 |
| Recruitment arrangements (for publication) | Transition statement -For publication | 1 |
| Recruitment arrangements (for publication) | Transition statement -For publication | 1 |
| Recruitment arrangements (for publication) | Transition statement -For publication | 1 |
| Subject information and informed consent form (for publication) | L1_AT NN9931-4553 SI-IC Future Research Genotyping_For publication | 4 |
| Subject information and informed consent form (for publication) | L1_AT NN9931-4553 SI-IC Main_For publication | 9 |
| Subject information and informed consent form (for publication) | L1_AT NN9931-4553 SI-IC Male Partner_For publication | 4 |
| Subject information and informed consent form (for publication) | L1_AT NN9931-4553 SI-IC Prescreen_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_BE NN9931-4553 SI-IC Future Research DU_For publication | 6 |
| Subject information and informed consent form (for publication) | L1_BE NN9931-4553 SI-IC Future Research FR_For publication | 6 |
| Subject information and informed consent form (for publication) | L1_BE NN9931-4553 SI-IC Main DU_For publication | 11.0 |
| Subject information and informed consent form (for publication) | L1_BE NN9931-4553 SI-IC Main FR_For publication | 11.0 |
| Subject information and informed consent form (for publication) | L1_BE NN9931-4553 SI-IC Male Partner DU_For publication | 5 |
| Subject information and informed consent form (for publication) | L1_BE NN9931-4553 SI-IC Male Partner FR_For publication | 5 |
| Subject information and informed consent form (for publication) | L1_BE NN9931-4553 SI-IC Pre-Screening DU_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_BE NN9931-4553 SI-IC Pre-Screening FR_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_BG NN9931-4553 SI-IC Direct to patient_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_BG NN9931-4553 SI-IC Future Research_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_BG NN9931-4553 SI-IC Main Adult_Master_ENG-For Publication | 8 |
| Subject information and informed consent form (for publication) | L1_BG NN9931-4553 SI-IC Main_For publication | 6 |
| Subject information and informed consent form (for publication) | L1_BG NN9931-4553 SI-IC Male Partner_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_BG NN9931-4553 SI-IC Pre-Screening_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_CZ NN9931-4553 SI-IC Direct To Patient_For publication | 5 |
| Subject information and informed consent form (for publication) | L1_CZ NN9931-4553 SI-IC Future Research_For publication | 5 |
| Subject information and informed consent form (for publication) | L1_CZ NN9931-4553 SI-IC GDPR enrolled subjects_For publication | 4 |
| Subject information and informed consent form (for publication) | L1_CZ NN9931-4553 SI-IC GDPR Subjects Consent_For publication | 4 |
| Subject information and informed consent form (for publication) | L1_CZ NN9931-4553 SI-IC Main For Enrolled Subjects_For publication | 9 |
| Subject information and informed consent form (for publication) | L1_CZ NN9931-4553 SI-IC Main_For publication | 9 |
| Subject information and informed consent form (for publication) | L1_CZ NN9931-4553 SI-IC Male Partner_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_CZ NN9931-4553 SI-IC Oznameni o zmene sidla spolecnosti Novo Nordisk_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_CZ NN9931-4553 SI-IC Pre-screen_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_DE NN9931-4553 SI-IC Direct To Patient_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_DE NN9931-4553 SI-IC Future Research and Genotyping_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_DE NN9931-4553 SI-IC Main_For publication | 11 |
| Subject information and informed consent form (for publication) | L1_DE NN9931-4553 SI-IC Male Partner_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_DE NN9931-4553 SI-IC Pre-screening_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_DK NN9931-4553 SI-IC Main_For publication | 7 |
| Subject information and informed consent form (for publication) | L1_DK NN9931-4553 SI-IC Pre-screening_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_DK_NN9931-4553 Other_Dine rettigheder som forsgsperson i forsg medicin_For Publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_ES_NN9931-4553 SI-IC Direct to patient_For publication | 4 |
| Subject information and informed consent form (for publication) | L1_ES_NN9931-4553 SI-IC Future Research Genotype-For publication | 3 |
| Subject information and informed consent form (for publication) | L1_ES_NN9931-4553 SI-IC Main_For publication | 8.0 |
| Subject information and informed consent form (for publication) | L1_ES_NN9931-4553 SI-IC Male partner_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_ES_NN9931-4553 SI-IC pre-screening_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_FR NN9931-4553 SI-IC Direct To Patient_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_FR NN9931-4553 SI-IC Future Research_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_FR NN9931-4553 SI-IC Main_For publication | 5.0 |
| Subject information and informed consent form (for publication) | L1_FR NN9931-4553 SI-IC Male Partner_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_FR NN9931-4553 SI-IC Pre-screening_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_GR NN9931-4553 SI-IC DTP_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_GR NN9931-4553 SI-IC Future Research_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_GR NN9931-4553 SI-IC Main_For publication | 8.0 |
| Subject information and informed consent form (for publication) | L1_GR NN9931-4553 SI-IC Male_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_GR NN9931-4553 SI-IC Pre-screening_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_HR NN9931-4553 SI-IC DTP_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_HR NN9931-4553 SI-IC Main_For publication | 8.0 |
| Subject information and informed consent form (for publication) | L1_HR NN9931-4553 SI-IC Male Partner_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_HR NN9931-4553 SI-IC Pre-screening_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_HR NN9931-4553 SI-IC Pregnant Participant_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_IE NN9931-4553 SI-IC Direct To Patient_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_IE NN9931-4553 SI-IC Future and Genetic_For publication | 4 |
| Subject information and informed consent form (for publication) | L1_IE NN9931-4553 SI-IC Main_For publication | 12 |
| Subject information and informed consent form (for publication) | L1_IE NN9931-4553 SI-IC Male Partner_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_IE NN9931-4553 SI-IC Pre-screening_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_IT NN9931-4553 SI-IC Data Privacy Main Adult_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_IT NN9931-4553 SI-IC Data Privacy Male partner_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_IT NN9931-4553 SI-IC Direct To Patient_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_IT NN9931-4553 SI-IC Future Research_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_IT NN9931-4553 SI-IC Main Adult_For publication | 6 |
| Subject information and informed consent form (for publication) | L1_IT NN9931-4553 SI-IC Male Partner_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_IT NN9931-4553 SI-IC Pre-Screening_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_NL NN9931-4553 SI-IC DTP_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_NL NN9931-4553 SI-IC Future Research GB_For publication | 4.1 |
| Subject information and informed consent form (for publication) | L1_NL NN9931-4553 SI-IC Future Research_For publication | 4.1 |
| Subject information and informed consent form (for publication) | L1_NL NN9931-4553 SI-IC Main GB_For publication | 8.1 |
| Subject information and informed consent form (for publication) | L1_NL NN9931-4553 SI-IC Main_For publication | 10.0 |
| Subject information and informed consent form (for publication) | L1_NL NN9931-4553 SI-IC Male Partner GB_For publication | 4.1 |
| Subject information and informed consent form (for publication) | L1_NL NN9931-4553 SI-IC Male Partner_For publication | 4.1 |
| Subject information and informed consent form (for publication) | L1_NL NN9931-4553 SI-IC Optional Pre-screening_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_NO_NN9931-4553 SI-IC Direct to patient_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_NO_NN9931-4553 SI-IC Main_For publication | 8 |
| Subject information and informed consent form (for publication) | L1_NO_NN9931-4553 SI-IC Male partner_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_NO_NN9931-4553 SI-IC pre-screening_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_PL_NN9931-4553 SI-IC Data processing form_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_PL_NN9931-4553 SI-IC Data processing form-Site specific only_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_PL_NN9931-4553 SI-IC Direct to patient_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_PL_NN9931-4553 SI-IC Future research_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_PL_NN9931-4553 SI-IC Main_For publication | 6 |
| Subject information and informed consent form (for publication) | L1_PL_NN9931-4553 SI-IC Main-Site specific only_For publication | 6 |
| Subject information and informed consent form (for publication) | L1_PL_NN9931-4553 SI-IC Male partner_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_PL_NN9931-4553 SI-IC Pre-screening_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_PT_NN9931-4553 SI-IC Direct to patient_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_PT_NN9931-4553 SI-IC Future Analysis_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_PT_NN9931-4553 SI-IC Main_For publication | 10.0 |
| Subject information and informed consent form (for publication) | L1_PT_NN9931-4553 SI-IC Male partner_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_PT_NN9931-4553 SI-IC Pre-screening_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_PT_NN9931-4553 SI-IC Pregnancy_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_RO_NN9931-4553 SI-IC Direct to patient_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_RO_NN9931-4553 SI-IC future research_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_RO_NN9931-4553 SI-IC Main_For publication | 8 |
| Subject information and informed consent form (for publication) | L1_RO_NN9931-4553 SI-IC Male partner _For publication | 2 |
| Subject information and informed consent form (for publication) | L1_RO_NN9931-4553 SI-IC pre-screening_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_SK_NN9931-4553 SI-IC Data Protection_For publication | 4 |
| Subject information and informed consent form (for publication) | L1_SK_NN9931-4553 SI-IC Direct to patient_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_SK_NN9931-4553 SI-IC Future Research Data Protection_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_SK_NN9931-4553 SI-IC Future Research_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_SK_NN9931-4553 SI-IC local ICF COVID-19_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_SK_NN9931-4553 SI-IC Main_For publication | 8 |
| Subject information and informed consent form (for publication) | L1_SK_NN9931-4553 SI-IC Male Partner_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_SK_NN9931-4553 SI-IC Pre-screening_For publication | 1 |
| Synopsis of the protocol (for publication) | D1_AT_NN9931-4553_Scientific Protocol Synopsis EU CT 2023-506962-30_German-For publication | 1 |
| Synopsis of the protocol (for publication) | D1_CZ_NN9931-4553_Protocol Synopsis Experts EU CT 2023-506962-30_Czech-For publication | 1 |
| Synopsis of the protocol (for publication) | D1_NN9931-4553_Protocol Synopsis EU CT 2023-506962-30_AT-German-For publication | 1 |
| Synopsis of the protocol (for publication) | D1_NN9931-4553_Protocol Synopsis EU CT 2023-506962-30_BE-Dutch-For publication | 1 |
| Synopsis of the protocol (for publication) | D1_NN9931-4553_Protocol Synopsis EU CT 2023-506962-30_BE-French-For publication | 1 |
| Synopsis of the protocol (for publication) | D1_NN9931-4553_Protocol Synopsis EU CT 2023-506962-30_BE-German-For publication | 1 |
| Synopsis of the protocol (for publication) | D1_NN9931-4553_Protocol Synopsis EU CT 2023-506962-30_BG-For publication | 1 |
| Synopsis of the protocol (for publication) | D1_NN9931-4553_Protocol Synopsis EU CT 2023-506962-30_CZ-For publication | 1 |
| Synopsis of the protocol (for publication) | D1_NN9931-4553_Protocol Synopsis EU CT 2023-506962-30_ENG-For publication | 1 |
| Synopsis of the protocol (for publication) | D1_NN9931-4553_Protocol Synopsis EU CT 2023-506962-30_ES-For publication | 1 |
| Synopsis of the protocol (for publication) | D1_NN9931-4553_Protocol Synopsis EU CT 2023-506962-30_FR-French-For publication | 1 |
| Synopsis of the protocol (for publication) | D1_NN9931-4553_Protocol Synopsis EU CT 2023-506962-30_GR-For publication | 1 |
| Synopsis of the protocol (for publication) | D1_NN9931-4553_Protocol Synopsis EU CT 2023-506962-30_IT-For publication | 1 |
| Synopsis of the protocol (for publication) | D1_NN9931-4553_Protocol Synopsis EU CT 2023-506962-30_NL-Dutch-For publication | 1 |
| Synopsis of the protocol (for publication) | D1_NN9931-4553_Protocol Synopsis EU CT 2023-506962-30_NO-For publication | 1 |
| Synopsis of the protocol (for publication) | D1_NN9931-4553_Protocol Synopsis EU CT 2023-506962-30_PL-For publication | 1 |
| Synopsis of the protocol (for publication) | D1_NN9931-4553_Protocol Synopsis EU CT 2023-506962-30_PT-For publication | 1 |
| Synopsis of the protocol (for publication) | D1_NN9931-4553_Protocol Synopsis EU CT 2023-506962-30_RO-For publication | 1 |
| Synopsis of the protocol (for publication) | D1_NN9931-4553_Protocol Synopsis EU CT 2023-506962-30_SK-For publication | 1 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-10 | Denmark | Acceptable 2024-05-13
|
2024-05-13 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-19 | Denmark | Acceptable 2024-11-15
|
2024-11-15 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-12-06 | Acceptable | 2025-01-24 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-12-09 | Acceptable | 2025-01-21 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-03-20 | Denmark | Acceptable 2025-06-04
|
2025-06-04 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-30 | Denmark | Acceptable 2025-06-04
|
2025-06-30 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-07-07 | Denmark | Acceptable 2025-09-08
|
2025-09-08 |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-10-29 | Acceptable | 2025-11-11 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-01-21 | Denmark | Acceptable | 2026-02-06 |