Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
3,415
Countries
10
Sites
80
Overweight and obesity
To confirm superiority on body weight reduction of CagriSema versus placebo as adjunct to reduced-calorie diet and increased physical activity in participants with overweight or obesity.
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] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 17 Oct 2022 → ongoing
- Decision date (initial)
- 2024-05-27
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Novo Nordisk A/S
External identifiers
- EU CT number
- 2023-506929-11-00
- EudraCT number
- 2020-005435-75
- WHO UTN
- U1111-1261-1912
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To confirm superiority on body weight reduction of CagriSema versus placebo as adjunct to reduced-calorie diet and increased physical activity in participants with overweight or obesity.
Secondary objectives 8
- To confirm superiority of CagriSema versus placebo on achievement of ≥ 20% weight reduction.
- To confirm superiority of CagriSema versus placebo on achievement of ≥ 25% weight reduction.
- To confirm superiority of CagriSema versus placebo on achievement of ≥ 30% weight reduction.
- To confirm superiority of CagriSema versus cagrilintide on body weight.
- To confirm superiority of CagriSema versus semaglutide on body weight.
- To confirm superiority of CagriSema versus placebo on body weight.
- To confirm superiority of CagriSema versus placebo on: Waist circumference Systolic blood pressure Physical functioning
- To compare the safety and tolerability of CagriSema versus placebo, semaglutide and cagrilintide.
Conditions and MedDRA coding
Overweight and obesity
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10029883 | Obesity | 100000004861 |
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
- IPD plan description
- Not Applicable
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Male or female
- Age above or equal to 18 years at the time of signing informed consent
- a) BMI ≥ 30.0 kg/m2 or b) BMI ≥ 27.0 kg/m2 with the presence of at least one obesity-related complication including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
Exclusion criteria 2
- HbA1c ≥ 6.5 % (48 mmol/mol) as measured by the central laboratory at screening
- History of type 1 or type 2 diabetes mellitus
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Relative change in body weight
- Achievement of ≥ 5% weight reduction
Secondary endpoints 10
- Achievement of ≥ 20% weight reduction
- Achievement of ≥ 25% weight reduction
- Achievement of ≥ 30% weight reduction
- Relative change in body weight
- Change in waist circumference
- Change in systolic blood pressure (SBP)
- Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score
- Change in SF-36 V2 Health Survey Acute (SF-36v2) Physical Functioning score
- Number of Treatment-emergent Adverse Events (TEAEs)
- Number of Treatment-emergent Serious adverse events (TESAEs)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
—
PRD8977530 · Product
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD8977528 · Product
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD8977531 · Product
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD8977529 · Product
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD8977527 · Product
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 10
—
PRD8977522 · Product
- Substance synonyms
- NNC0113-0217
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD8977525 · Product
- Substance synonyms
- NNC0113-0217
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD8977524 · Product
- Substance synonyms
- NNC0113-0217
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD8977526 · Product
- Substance synonyms
- NNC0113-0217
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD8977523 · Product
- Substance synonyms
- NNC0113-0217
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD8977518 · Product
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD8977521 · Product
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD8977520 · Product
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD8977519 · Product
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
—
PRD8977517 · Product
- Substance synonyms
- NNC0174-0833, NN9838, N-alfa-[(S)-4-Carboxy-4-(19-carboxynonadecanoylamino)butyryl]-[Glu14,Arg17,Pro25,Pro28,Pro29,Pro37]-human amylin
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
—
N/A · Product
- Other product name
- 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 13
| Organisation | City, country | Duties |
|---|---|---|
| Q Squared Solutions Limited ORG-100042527
|
Reading, United Kingdom | Laboratory analysis |
| Icon (Lr) Limited ORG-100042612
|
Dublin 18, Ireland | Other |
| Somalogic Operating Co. Inc. ORG-100042788
|
Boulder, United States | Other |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Other |
| 4G Clinical B.V. ORG-100044721
|
Amsterdam, Netherlands | Other |
| Transperfect Translations International Inc. ORG-100043494
|
New York, United States | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| HCL Technologies Denmark Aps ORG-100051223
|
Copenhagen Oe, Denmark | Other |
| Marken Limited ORG-100050177
|
London, United Kingdom | Other |
| IQVIA Limited ORG-100008655
|
Livingston, United Kingdom | Other |
| Oracle America Inc. ORG-100039874
|
Redwood City, United States | Other |
| Celerion Switzerland AG ORG-100013062
|
Fehraltorf, Switzerland | Other |
| SYRINX Bioanalytics Oy ORG-100021026
|
Turku, Finland | Other |
Locations
10 EU/EEA countries · 80 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 75 | 6 |
| Bulgaria | Ongoing, recruitment ended | 177 | 15 |
| Denmark | Ongoing, recruitment ended | 90 | 5 |
| Finland | Ongoing, recruitment ended | 101 | 4 |
| France | Ongoing, recruitment ended | 62 | 5 |
| Germany | Ongoing, recruitment ended | 113 | 9 |
| Italy | Ongoing, recruitment ended | 126 | 9 |
| Netherlands | Ongoing, recruitment ended | 101 | 5 |
| Poland | Ongoing, recruitment ended | 187 | 15 |
| Spain | Ongoing, recruitment ended | 69 | 7 |
| Rest of world
Australia, Mexico, Korea, Democratic People's Republic of, United States, India, Japan, Taiwan, Argentina, Canada, South Africa, Turkey, United Kingdom
|
— | 2,314 | — |
Investigational sites
UZ Leuven
N/A, Herestraat 49, 3000, Leuven
CHU Helora
N/A, Rue Des Chaufours 27, 7300, Boussu
Antwerp University Hospital
N/A, Drie Eikenstraat 655, 2650, Edegem
Imelda
N/A, Imeldalaan 9, 2820, Bonheiden
Universitair Ziekenhuis Gent
N/A, Corneel Heymanslaan 10, 9000, Gent
Cliniques Universitaires Saint-Luc
N/A, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Diagnostic Consultation Center XX-Sofia EOOD
Endocrinology and Metabolic Diseases Consulting Room, Ulitsa Gen. Stefan Toshev 15, 1618, Sofia
Diagnostichno-Konsultativen Tsentar XVIII-Sofia OOD
Cabinet №40, Ulitsa Emanuil Vaskidovich 51, 1517, Sofia
Alexandrovska University Hospital
Department of Clinical Densitometry and Bone Metabolic Diseases, Georgy Sofiiski Str 1, 1431, Sofia
Outpatient Clinic For Individual Practice For Specialized Outpatient Medical Care Endocrinology Nt EOOD
NA, Tsar Boris III Str 11a Floor 4 Consulting Room 406, 3400, Montana
Diagnostic And Consulting Center East Ltd.
Cabinet №11, Hrabrec Street 15 Cabinet 11, 4006, Plovdiv
Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
Clinic of endocrinology and metabolic disease for metabolic disorders treatment, Oborishte Distr., Ul.Byalo More 8, Sofia
Asclepius Medical Center OOD
Endocrinology and Metabolic Diseases Consulting Room, Ploshtad Svoboda 1, 2600, Dupnitsa
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD
Department of Internal diseases, Ulitsa Slavyanska 62, 2700, Blagoevgrad
Outpatient Clinic for Specialized Outpatient Medical Care in Endocrinology and Metabolic Diseases
N/A, 37 Saedinenie Blvd., 7002, Ruse
Medical Center Berbatov Ltd.
N/A, Ulitsa Cherni Drin 15, 8600, Yambol
Outpatient Clinic For Specialized Outpatient Medical Care In Endocrinology Dr Albena Dinkova EOOD
Ground floor, Ulitsa Boris Shivachev 14, 5801, Pleven
Ambulatory For Individual Practice And Specialized Medical Aid Dr. Artin Magardichian Ltd.
Consulting room 402 A, Building A Consulting Room 402a, Bulevard Republika 15, Varna
University Specialized Hospital For Active Treatment In Endocrinology Akad. Iv. Penchev EAD
First Clinic of Endocrinology and Metabolic Diseases, Ulitsa Zdrave 2, 1431, Sofiya
University Specialized Hospital For Active Treatment In Endocrinology Akad. Iv. Penchev EAD
Second Clinic of Endocrinology and Metabolic Diseases, Ulitsa Zdrave 2, 1431, Sofiya
Nader Yabrudi - ambulatory for specialized medical care of internal diseases and endocrinology
Room 11, 1z "Bulgaria" blvd., Room 11, Smolyan
Esbjerg Og Grindsted Sygehus
N/A, Finsensgade 35, 6700, Esbjerg
Hvidovre Hospital
N/A, Kettegaard Alle 30, 2650, Hvidovre
Region Sjaelland
N/A, Lykkebaekvej 1, 4600, Koege
Gentofte Hospital
N/A, Gentofte Hospitalsvej 1, 2900, Hellerup
Aarhus Universitetshospital
N/A, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
HUS-Yhtymae
N/A, Haartmaninkatu 8, 00290, Helsinki
Turku University Hospital
N/A, Kiinamyllynkatu 4-8, 20520, Turku
Health Step Finland Oy
N/A, Medistudia 5th Floor, Yliopistonrinne 3, Kuopio
Oulu University Hospital
N/A, Kajaanintie 50, 90220, Oulu
Centre De Recherche Clinique Portes Du Sud
N/A, 2 Avenue Du 11 Novembre 1918, 69200, Venissieux
Les Hopitaux Universitaires De Strasbourg
N/A, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Assistance Publique Hopitaux De Paris
N/A, 43 Boulevard De L Hopital, 75013, Paris
Centre Hospitalier Universitaire De Nantes
N/A, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Hospices Civils De Lyon
N/A, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
MVZ DiaMedicum Bad Mergentheim GmbH
N/A, Theodor-Klotzbuecher-Strasse 12, 97980, Bad Mergentheim
Universitaet Leipzig
N/A, Liebigstrasse 20, Zentrum-Suedost, Leipzig
InnoDiab Forschung GmbH
N/A, Eleonorastrasse 42, Ruettenscheid, Essen
Institut fuer Diabetesforschung Muenster GmbH
N/A, Hohenzollernring 70, Herz-Jesu, Muenster
Wendisch/Dahl Hamburg
N/A, Beselerstr. 2a, Gemeinschaftspraxis für Innere Medizin, Hamburg
MZM Praxis Drs. Erlinger
N/A, Hechtstr. 66, 70378, Stuttgart
Zentrum für klinische Forschung Allgäu Oberschwaben
N/A, Herrenstrasse 22+24, 88239, Wangen
Ambenet GmbH Das Ambulante Behandlungsnetz
N/A, Wilhelm-Leuschner-Platz 12, Zentrum-Süd, Leipzig
Zentrum fuer klinische Studien Suedbrandenburg GmbH
N/A, Lange Strasse 13, 04910, Elsterwerda
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
N/A, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedale-Universita Padova
N/A, Via Nicolo' Giustiniani 2, 35128, Padova
Ospedale Garibaldi
N/A, Piazza Santa Maria Di Gesu, 95123, Catania
Azienda Ospedaliera Policlinico Universitario Tor Vergata
N/A, Viale Oxford 81, 00133, Rome
IRCCS Policlinico San Donato
N/A, Piazza Edmondo Malan 2, 20097, San Donato Milanese
Azienda Ospedaliera Universitaria Mater Domini
N/A, Viale Tommaso Campanella 115, 88100, Catanzaro
Azienda Ospedaliero-Universitaria Policlinico Umberto I
N/A, Viale Del Policlinico 155, 00161, Rome
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
N/A, Via Alvaro Del Portillo N 200, 00128, Rome
Azienda Ospedaliera Universitaria Senese
N/A, Viale Mario Bracci 1, 53100, Siena
Spaarne Gasthuis Stichting
N/A, Spaarnepoort 1, 2134 TM, Hoofddorp
Bravis Ziekenhuis
N/A, Boerhaavelaan 25, 4708 AE, Roosendaal
Academisch Medisch Centrum
N/A, Meibergdreef 9, 1105 AZ, Amsterdam
Albert Schweitzer Ziekenhuis
N/A, Langeweg 336, 3331 LZ, Zwijndrecht
Rijnstate Ziekenhuis Stichting
N/A, Wagnerlaan 55, 6815 AD, Arnhem
Gabinet Leczenia Otyłości i Chorób Dietozależnych
N/A, ul. Legionowa 9A, 15-281, Białystok
Uniwersyteckie Centrum Kliniczne
N/A, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Niepubliczny Zakład Opieki Zdrowotnej Vita-Diabetica Małgorzata Buraczyk
N/A, ul. św. Rocha 12A lok. 5 i 6, 15-879, Białystok
Centrum Ginekologii Poloznictwa I Leczenia Nieplodnosci Pastelova Sp z.o.o.
N/A, Ul. Pastelowa 8, 60-198, Poznan
Salvia Lekston I Madej Sp. J.
N/A, Ul. Panewnicka 201/1, 40-772, Katowice
Terpa Sp. z o.o. S.K.
N/A, Ul. Pogodna 34, 20-337, Lublin
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
N/A, U2 U3 U4 U5, Ul. Tadeusza Szafrana 5d, Cracow
Klinika Bellamed
N/A, ul. Studzienna 33/34 A, 82-300, Elbląg
50BIO.COM sp. z o.o., Przychodnia "Przy Szpitalu"
N/A, ul. Marii Curie Skłodowskiej 26, 85-107, Bydgoszcz
Centrum Kardiometaboliczne Gierach-Med Marcin Gierach
N/A, Ul. Bydgoskich Olimpijczykow 5/39-40, 85-796, Bydgoszcz
Beata Miklaszewicz & Dariusz Dabrowski Cardiamed Sp. j.
N/A, Ul. Grunwaldzka 7, 59-220, Legnica
Centrum Zdrowia Metabolicznego
N/A, ul. Nowina 14 F, 60-589, Poznań
Samodzielny Publiczny Szpital Kliniczny Im. Prof. W. Orlowskiego CMKP
N/A, Ul. Ulica Czerniakowska 231, 00-416, Warsaw
Uniwersytecki Szpital Kliniczny W Bialymstoku
N/A, Ul. Marii Curie-Sklodowskiej 24a, 15-276, Bialystok
Instytut Diabetologii Sp. z o.o.
N/A, Ul. Raclawicka 129/2u, 02-117, Warsaw
Hospital Clinic De Barcelona
N/A, Calle Villarroel 170, 08036, Barcelona
Area De Salud De Leon Y El Bierzo
N/A, Calle Altos De Nava S/N, 24008, Leon
Hospital General Universitario Gregorio Maranon
N/A, Calle Del Doctor Esquerdo 46, 28007, Madrid
Clinica Universidad De Navarra
N/A, Avenue Pio XII 36, 31008, Pamplona
Hospital Nisa Sevilla Aljarafe
N/A, Avenida Placido Fernandez Viagas S/n, 41950, Castilleja De La Cuesta
Hospital Quironsalud Infanta Luisa
N/A, Calle De San Jacinto 87, 41010, Sevilla
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
N/A, Calle Alejo Fernandez 9, 41003, Sevilla
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 |
|---|---|---|---|---|---|
| Belgium | 2023-01-23 | 2023-01-30 | 2023-06-28 | ||
| Bulgaria | 2022-12-05 | 2022-12-08 | 2023-06-19 | ||
| Denmark | 2022-10-28 | 2022-11-01 | 2023-06-27 | ||
| Finland | 2022-10-17 | 2022-11-01 | 2023-06-06 | ||
| France | 2023-04-14 | 2023-04-17 | 2023-06-16 | ||
| Germany | 2023-01-03 | 2023-01-04 | 2023-06-15 | ||
| Italy | 2022-12-06 | 2022-12-12 | 2023-06-19 | ||
| Netherlands | 2022-11-17 | 2023-01-05 | 2023-06-26 | ||
| Poland | 2022-11-02 | 2022-11-03 | 2023-06-19 | ||
| Spain | 2023-01-27 | 2023-01-30 | 2023-06-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 65 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1_nn9838-4608-protocol-2023-506929-11-english_for-publication | 6 |
| 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 |
| Subject information and informed consent form (for publication) | L1_BE NN9838-4608 SI-IC Future Research DU_For publication | 4.0 |
| Subject information and informed consent form (for publication) | L1_BE NN9838-4608 SI-IC Future Research FR_For publication | 4.0 |
| Subject information and informed consent form (for publication) | L1_BE NN9838-4608 SI-IC Main DU_For publication | 8.0 |
| Subject information and informed consent form (for publication) | L1_BE NN9838-4608 SI-IC Main FR_For publication | 8.0 |
| Subject information and informed consent form (for publication) | L1_BE NN9838-4608 SI-IC Male Partner DU_For publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_BE NN9838-4608 SI-IC Male Partner FR_For publication | 3.0 |
| Subject information and informed consent form (for publication) | L1_BG NN9838-4608 SI-IC DTP_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_BG NN9838-4608 SI-IC Future Research_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_BG NN9838-4608 SI-IC Main_For publication | 4 |
| Subject information and informed consent form (for publication) | L1_BG NN9838-4608 SI-IC Male Partner_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_DE NN9838-4608 SI-IC Direct To Patient_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_DE NN9838-4608 SI-IC Future Research_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_DE NN9838-4608 SI-IC Main_For publication | 7 |
| Subject information and informed consent form (for publication) | L1_DE NN9838-4608 SI-IC Male Partner_For publication | 3.1 |
| Subject information and informed consent form (for publication) | L1_DK NN9838-4608 SI-IC Direct To Patient_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_DK NN9838-4608 SI-IC Main_For publication | 8 |
| Subject information and informed consent form (for publication) | L1_ES NN9838-4608 SI-IC Direct To Patient_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_ES NN9838-4608 SI-IC Future Research_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_ES NN9838-4608 SI-IC Main_For publication | 4 |
| Subject information and informed consent form (for publication) | L1_ES NN9838-4608 SI-IC Male Partner_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_FI NN9838-4608 SI-IC Direct To Patient_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_FI NN9838-4608 SI-IC Main Attachment 1_For publication | 4 |
| Subject information and informed consent form (for publication) | L1_FI NN9838-4608 SI-IC Main Attachment 2_For publication | 4 |
| Subject information and informed consent form (for publication) | L1_FI NN9838-4608 SI-IC Main_For publication | 5 |
| Subject information and informed consent form (for publication) | L1_FI NN9838-4608 SI-IC Male Partner_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_FR NN9838-4608 SI-IC Direct To Patient_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_FR NN9838-4608 SI-IC Main Adult_For publication | 5 |
| Subject information and informed consent form (for publication) | L1_FR NN9838-4608 SI-IC Male Partner_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_IT NN9838-4608 SI-IC Direct to Patient-For Publication | 2 |
| Subject information and informed consent form (for publication) | L1_IT NN9838-4608 SI-IC Future Research-For Publication | 3 |
| Subject information and informed consent form (for publication) | L1_IT NN9838-4608 SI-IC Main-For Publication | 5 |
| Subject information and informed consent form (for publication) | L1_IT NN9838-4608 SI-IC Male Partner-For Publication | 2 |
| Subject information and informed consent form (for publication) | L1_NL NN9838-4608 SI-IC Direct Shipment of IMP_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_NL NN9838-4608 SI-IC Future_For publication | 4 |
| Subject information and informed consent form (for publication) | L1_NL NN9838-4608 SI-IC Main_For publication | 6 |
| Subject information and informed consent form (for publication) | L1_NL NN9838-4608 SI-IC Male Partner_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_NL NN9838-4608 SI-IC Revoke Consent Biobank_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_PL NN9838-4608 SI-IC Data Processing Option 1_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_PL NN9838-4608 SI-IC Data Processing Option 2_For publication | 3 |
| Subject information and informed consent form (for publication) | L1_PL NN9838-4608 SI-IC DTP_For publication | 1 |
| Subject information and informed consent form (for publication) | L1_PL NN9838-4608 SI-IC Future Research_For publication | 2 |
| Subject information and informed consent form (for publication) | L1_PL NN9838-4608 SI-IC Main_For publication | 4 |
| Subject information and informed consent form (for publication) | L1_PL NN9838-4608 SI-IC Male Partner_For publication | 1 |
| Synopsis of the protocol (for publication) | d1_be_nn9838-4608-protocol-synopsis-2023-506929-11-dutch-_for-publication | 1 |
| Synopsis of the protocol (for publication) | d1_be_nn9838-4608-protocol-synopsis-2023-506929-11-french-_for-publication | 1 |
| Synopsis of the protocol (for publication) | d1_be_nn9838-4608-protocol-synopsis-2023-506929-11-german-_for-publication | 1 |
| Synopsis of the protocol (for publication) | d1_bg_nn9838-4608-protocol-synopsis-2023-506929-11-bulgarian-_for-publication | 1 |
| Synopsis of the protocol (for publication) | d1_es_nn9838-4608-protocol-synopsis-2023-506929-11-spanish-_for-publication | 1 |
| Synopsis of the protocol (for publication) | d1_fr_nn9838-4608-protocol-synopsis-2023-506929-11-french-_for-publication | 1 |
| Synopsis of the protocol (for publication) | d1_it_nn9838-4608-protocol-synopsis-2023-506929-11-italian-_for-publication | 1 |
| Synopsis of the protocol (for publication) | d1_nl_nn9838-4608-protocol-synopsis-2023-506929-11-dutch-_for-publication | 1 |
| Synopsis of the protocol (for publication) | d1_nn9838-4608-protocol-synopsis-2023-506929-11-english_for-publication | 1 |
| Synopsis of the protocol (for publication) | d1_pl_nn9838-4608-protocol-synopsis-2023-506929-11-polish-_for-publication | 1 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-15 | Denmark | Acceptable 2024-05-21
|
2024-05-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-20 | Denmark | Acceptable 2024-10-16
|
2024-10-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-13 | Denmark | Acceptable 2025-03-14
|
2025-03-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-06-03 | Acceptable | 2025-06-24 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-03 | Denmark | Acceptable | 2025-06-23 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-09-12 | Denmark | Acceptable 2025-11-21
|
2025-11-21 |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-03-16 | Denmark | Acceptable 2026-05-01
|
2026-05-01 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-29 | Acceptable 2026-05-01
|
2026-05-29 |