Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
1,000
Countries
7
Sites
66
Participants with overweight or obesity, and type 2 diabetes
To confirm superiority of 00 mg NNC0487-0111 versus 00 mg semaglutide on change in body weight in participants with overweight or obesity, and type 2 diabetes (T2D).
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
- 27 May 2026 → ongoing
- Decision date (initial)
- 2026-05-20
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Novo Nordisk A/S
External identifiers
- EU CT number
- 2024-520446-31-00
- WHO UTN
- U1111-1313-8017
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
To confirm superiority of 00 mg NNC0487-0111 versus 00 mg semaglutide on change in body weight in participants with overweight or obesity, and type 2 diabetes (T2D).
Secondary objectives 10
- CCI
- To confirm non-inferiority of 00 mg NNC0487-0111 versus 00 mg semaglutide on glucose metabolism in participants with overweight or obesity, and T2D
- To confirm superiority of 00 mg NNC0487-0111 versus 00 mg semaglutide in participants with overweight or obesity, and T2D on: Waist circumference Systolic blood pressure
- To compare the effect of 00 mg NNC0487-0111 versus 00 mg semaglutide in participants with overweight or obesity, and T2D on: Body weight Body mass index (BMI)
- CCI
- To compare the effect of 00 mg NNC0487-0111 versus 00 mg semaglutide in participants with overweight or obesity, and T2D on: Glucose metabolism Urinary albumin-to-creatinine ratio (UACR)
- To compare the effect of 00 mg NNC0487-0111 versus 00 mg semaglutide in participants with overweight or obesity, and T2D on: Diastolic blood pressure Lipids High-sensitivity C-reactive protein (hsCRP)
- To compare the safety and tolerability of 00 mg NNC0487-0111 versus 00 mg semaglutide in participants with overweight or obesity, and T2D
- Extension phase secondary objectives are as follows; To compare the effect of 00 mg NNC0487-0111 versus 00 mg semaglutide in participants with overweight or obesity, and T2D on: Body weight Body mass index (BMI)
- To compare the safety and tolerability of 00 mg NNC0487-0111 versus 00 mg semaglutide in participants with overweight or obesity, and T2D
Conditions and MedDRA coding
Participants with overweight or obesity, and type 2 diabetes
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-520440-42-00 | Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with obesity (AMAZE 1) | Novo Nordisk A/S |
| 2024-520442-36-00 | Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with overweight or obesity, and obstructive sleep apnoea not treated with positive airway pressure (AMAZE 3) | Novo Nordisk A/S |
| 2024-520444-42-00 | Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with overweight or obesity, and knee osteoarthritis (AMAZE 5) | Novo Nordisk A/S |
| 2024-520443-16-00 | Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with overweight or obesity, and obstructive sleep apnoea treated with positive airway pressure (AMAZE 4) | Novo Nordisk A/S |
| 2024-520445-23-00 | Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with overweight or obesity, and knee osteoarthritis (AMAZE 6) | Novo Nordisk A/S |
| 2024-520441-23-00 | Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with overweight or obesity, and type 2 diabetes (AMAZE 2) | Novo Nordisk A/S |
| 2025-523804-62-00 | Efficacy and safety of NNC0487-0111s.c once weekly in participants with obesity who have reached target dose during run-in period (AMAZE12). | Novo Nordisk A/S |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- 1. Male or female (sex at birth)
- 2. Age 18 years or above at the time of signing informed consent
- 3. BMI ≥ CCI kg/m2 at screening
- 4. CCI
- 5. Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
- 6. Haemoglobin A1c (HbA1c) 7-10% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening.
- 7. Treatment with lifestyle intervention, and/or 0-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) for at least CCI days before screening.
Exclusion criteria 5
- 1. Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m2 (2021 CKD-EPI formula), at screening.
- 2. Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- 3. Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire question 8.
- 4. Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
- 5. Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), or amylin analogues within CCI before screening.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Relative change in body weight
Secondary endpoints 30
- CCI
- CCI
- CCI
- Change in haemoglobin A1c (HbA1c)
- Change in waist circumference
- Change in systolic blood pressure (SBP):
- Change in body weight
- Change in body mass index (BMI)
- CCI
- Achievement of HbA1c < 7.0% (Yes/No)
- Achievement of HbA1c ≤ 6.5% (Yes/No)
- Achievement of HbA1c < 5.7% (Yes/No)
- Change in fasting plasma glucose (FPG)
- Change in fasting insulin
- Change in urinary albumin-to-creatinine ratio (UACR)
- Change in diastolic blood pressure (DBP)
- Change in lipids: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol Triglycerides
- Change in high-sensitivity C-reactive protein (hsCRP)
- Number of Treatment Emergent Adverse Events (TEAEs)
- Number of Treatment Emergent Serious Adverse Events (TESAEs)
- Number of TEAEs leading to permanent treatment discontinuation
- Number of treatment-emergent clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L (54 mg/dL), confirmed by a blood glucose (BG) meter)
- Number of treatment-emergent severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold
- Extension phase secondary endpoints are as follows; Change in body weight
- Change in body mass index (BMI)
- Number of TEAEs
- Number of TESAEs
- Number of TEAEs leading to permanent treatment discontinuation
- Number of treatment-emergent clinically significant hypoglycaemic episodes (level 2) (< 3.0 mmol/L (54 mg/dL), confirmed by BG meter)
- Number of treatment-emergent severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
PRD12154765 · Product
- Active substance
- Zenagamtide
- Substance synonyms
- Polypeptide consisting of a glucagon-like peptide-1 receptor agonist and an amylin receptor agonist, connected by a linker with 4 glycine residues, and connected to a C18 fatty acid side chain, NNC0487-0111, Amycretin
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD12193544 · Product
- Active substance
- Zenagamtide
- Substance synonyms
- Polypeptide consisting of a glucagon-like peptide-1 receptor agonist and an amylin receptor agonist, connected by a linker with 4 glycine residues, and connected to a C18 fatty acid side chain, NNC0487-0111, Amycretin
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD12154764 · Product
- Active substance
- Zenagamtide
- Substance synonyms
- Polypeptide consisting of a glucagon-like peptide-1 receptor agonist and an amylin receptor agonist, connected by a linker with 4 glycine residues, and connected to a C18 fatty acid side chain, NNC0487-0111, Amycretin
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD12154763 · Product
- Active substance
- Zenagamtide
- Substance synonyms
- Polypeptide consisting of a glucagon-like peptide-1 receptor agonist and an amylin receptor agonist, connected by a linker with 4 glycine residues, and connected to a C18 fatty acid side chain, NNC0487-0111, Amycretin
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD12154758 · Product
- Active substance
- Zenagamtide
- Substance synonyms
- Polypeptide consisting of a glucagon-like peptide-1 receptor agonist and an amylin receptor agonist, connected by a linker with 4 glycine residues, and connected to a C18 fatty acid side chain, NNC0487-0111, Amycretin
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
PRD12154759 · Product
- Active substance
- Zenagamtide
- Substance synonyms
- Polypeptide consisting of a glucagon-like peptide-1 receptor agonist and an amylin receptor agonist, connected by a linker with 4 glycine residues, and connected to a C18 fatty acid side chain, NNC0487-0111, Amycretin
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- NOVO NORDISK A/S
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 5
Wegovy 1.7 mg FlexTouch solution for injection in pre-filled pen
PRD9862212 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/21/1608/009
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Wegovy 2.4 mg FlexTouch solution for injection in pre-filled pen
PRD9862213 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 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 0.25 mg FlexTouch solution for injection in pre-filled pen
PRD9862209 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/21/1608/006
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Wegovy 0.5 mg FlexTouch solution for injection in pre-filled pen
PRD9862210 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/21/1608/007
- MA holder
- NOVO NORDISK A/S
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Wegovy 1 mg FlexTouch solution for injection in pre-filled pen
PRD9862211 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/21/1608/008
- 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 8
| Organisation | City, country | Duties |
|---|---|---|
| 4G Clinical B.V. ORG-100044721
|
Amsterdam, Netherlands | Other |
| Celerion Switzerland AG ORG-100013062
|
Fehraltorf, Switzerland | Other |
| Marken Limited ORG-100050177
|
London, United Kingdom | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Iqvia Biotech Limited ORG-100008726
|
Reading, United Kingdom | Other |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | Other |
| Roche Diabetes Care Inc. ORG-100047645
|
Indianapolis, United States | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
Locations
7 EU/EEA countries · 66 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Bulgaria | Authorised, recruiting | 80 | 10 |
| Croatia | Authorised, recruiting | 50 | 8 |
| Germany | Ongoing, recruiting | 45 | 10 |
| Hungary | Authorised, recruiting | 45 | 5 |
| Poland | Ongoing, recruiting | 130 | 17 |
| Portugal | Authorised, recruiting | 40 | 8 |
| Romania | Ongoing, recruiting | 50 | 8 |
| Rest of world
Turkey, Mexico, Thailand, United States, India, Brazil, Argentina
|
— | 560 | — |
Investigational sites
Dr. Tatyana Metalova Ambulatoria Za Individualna Praktika Za Spetsializirana Meditsinska EOOD
room 233, Ulitsa Stara Planina 54, Floor 2 Room 23, Gotse Delchev
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD
Department of Endocrinology and Metabolic Diseases, Bulevard Gen. Stoletov No 67a, 1233, Sofia
University Multiprofile Hospital For Active Treatment Pulmed Ltd.
Department of Internal Diseases, Ulitsa Konstantin Velichkov 50, 4400, Pazardzhik
Multispecialty hospital for active treatment Sveta Sofia EOOD
Department of Endocrinology and metabolic diseases, Bulevard Bilgariya 104, 1404, Sofiya
University Specialized Hospital For Active Treatment In Endocrinology Akad. Iv. Penchev EAD
Second clinic of endocrinology and metabolic diseases, Ulitsa Zdrave 2, 1431, Sofia
Medcenter Nova Clinic Ltd.
ground floor, Ulitsa Vyara 7, 9020, Varna
Medical Center Zdrave-1 OOD
NA, Slaveykov Str 4, 3320, Kozloduy
Medical Institute Ministry Of Interior
Clinic of Endocrinology and Metabolic Diseases, Bulevard Gen. Skobelev 79, 1606, Sofia
Acibadem City Clinic Tokuda University Hospital EAD
Clinic of Internal Diseases, Department of Endocrinology and Metabolic Diseases, Bulevard Nikola Yonkov Vaptsarov 51b, 1407, Sofiya
Diagnostic-Consultative Center I Pleven EOOD
Endocrinology and Metabolic Diseases consulting room, Ulitsa Panega 28, 5801, Pleven
Poliklinika MEDIKOL
NA, Vocarska Cesta 106, Zagreb, Grad Zagreb
Poliklinika SLAVONIJA OSIJEK za opcu kirurgiju radiologiju baromedicinu ginekologiju i porodiljstvo i internu medicinu
NA, Josipa Jurja Strossmayera 163, 31000, Osijek
Opca Bolnica Karlovac
NA, Dr. Andrije Stampara 3, 47000, Karlovac
General Hospital Dr. Josip Bencevic
NA, Ulica Dr. Andrije Stampara 42, 35000, Slavonski Brod
Clinical Hospital Centre Rijeka
NA, Kresimirova 42, 51000, Rijeka
Opca Bolnica Varazdin
NA, Ulica Ivana Mestrovica 1, 42000, Varazdin
Poliklinika Solmed d.o.o.
NA, Preradoviceva Ulica 20, Zagreb, Grad Zagreb
Specijalna Bolnica Za Medicinsku Rehabilitaciju Krapinske Toplice
NA, Ulica Ljudevita Gaja 2, 49217, Krapinske Toplice
Diabetes-Zentrum-Wilhelmsburg GbR
NA, Krieterstrasse 30, Wilhelmsburg, Hamburg
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
NA, Georgstrasse 11, Innenstadt, Bad Oeynhausen
Zentrum fuer klinische Studien Suedbrandenburg GmbH
NA, Bahnhofstrasse 22, 04910, Elsterwerda
Praxis am Markt Dr. Becker
NA, Weidkamp 1, 45355, Essen
KliFoCenter GmbH
Forschungszentrum Ruhr, Diakonissenstrasse 8, Mitte, Witten
Centrum Fuer Diabetologie Und Allgemeinmedizin
CEDA, Haus 4, Neue Mitte 10, Pohlheim
Smo Md GmbH
Zentrum für klinische Studien, Bierer Weg 9, Leipziger Str., Magdeburg
Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz
NA, Praxis Dr. med. Staudenmeyer, Am Wall Süd 20, Lingen
MVZ im Altstadt-Carree Fulda GmbH
NA, Dalbergstrasse 22, Innenstadt, Fulda
Institut für Diabetesforschung Osnabrück
NA, Blumenhaller Weg 11, 49080, Osnabrück
Borbanya Praxis Egeszsegugyi Kft.
NA, Bazsalikom Utca 1/1, Borbanya, Nyiregyhaza
Komaromi Selye Janos Korhaz
Belgyógyászati szakrendelés, Beothy Zsolt Utca 4, 2900, Komarom
Obudai Egeszseguegyi Centrum Kft.
NA, Lajos Utca 74-76, 1036, Budapest III
Bekes Varmegyei Koezponti Korhaz
Pándy Kálmán Tagkórház, Semmelweis Utca 1, 5700, Gyula
University Of Debrecen
Gyógyszer- és Élelmiszerfejlesztési Koordinációs Központ, Nagyerdei Korut 98, 4032, Debrecen
Ekamed Sp. z o.o.
NA, Aleja Krasnicka 2j/u1, 20-718, Lublin
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
NA, Ul. 3 Maja 13/15, 41-800, Zabrze
Gabinety Medyczne MATUSZEK Beata Matyjaszek-Matuszek Prywatna Praktyka Specjalistyczna
N/A, ul. Północna 24/U3, 20-064, Lublin
Niepublicznego Zakladu Opieki Zdrowotnej Specjalistyczny Osrodek Internistyczno Diabetologiczny
NA, Ul. Ludwika Zamenhofa 10/20, 15-435, Bialystok
Diamond Clinic Sp. z o.o.
NA, Ul. Stefana Rogozinskiego 6/U3, 31-559, Cracow
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
NA, Ul. Przedzalniana 66, 90-338, Lodz
Gabinet Lekarski Malgorzata Saryusz-Wolska
NA, ul. Tramwajowa 19, 90-132, Lodz
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.
NA, Ul. Piotra Niedurnego 50 D, 41-709, Ruda Slaska
Serce Sp. z o.o.
NA, Ul. Fabryczna 15, 64-100, Leszno
Lukmed 2 Sp. z o.o.
NA, Ul. Mlynarska 16 B, 08-110, Siedlce
Linden Sp. z o.o. sp.k.
N/A, Ul. Tadeusza Kosciuszki 39/Lu4, 30-105, Cracow
Niepubliczny Zakład Opieki Zdrowotnej Vita-Diabetica Małgorzata Buraczyk
NA, ul. św. Rocha 12A lok. 5 i 6, 15-879, Białystok
Legeartis Poradnie Specjalistyczne Sp. z o.o.
NA, Ul. Mlynowa 17, 15-404, Bialystok
Beata Miklaszewicz & Dariusz Dabrowski Cardiamed Sp. j.
N/A, Ul. Grunwaldzka 7, 59-220, Legnica
Prywatna Praktyka Lekarska Anna Chudoba
NA, ul. M. Kopernika 31, 96-300, Żyrardów
Przychodnie Grudziadz Sp. z o.o.
NA, Ul. Legionow 21/23, 86-300, Grudziadz
Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
NA, Szarych Szeregow 38/III/1, 66-400, Gorzow Wielkopolski
CCAB Centro Clinico Academico Braga Associacao
NA, Lugar De Sete Fontes S Victor, 4710-243, Braga
Galo Saude Parcerias Cascais S.A.
NA, Avenida Brigadeiro Victor Novais Goncalves, Cobre, Cascais
APDP Associacao Protectora Dos Diabeticos De Portugal
NA, Rua Rodrigo Da Fonseca 1, 1250-189, Lisbon
Unidade Local De Saude De Almada-Seixal E.P.E.
NA, Avenida Torrado Da Silva, 2805-267, Almada
Hospital Da Luz Arrabida S.A.
NA, Praceta Henrique Moreira 150, 4400-346, Vila Nova De Gaia
Unidade Local de Saude de Sao Joao E.P.E.
NA, Alameda Professor Hernani Monteiro, 4200-319, Porto
Unidade Local De Saude De Matosinhos E.P.E.
NA, Rua Doutor Eduardo Torres, 4464-513, Senhora Da Hora
Hospital Das Forcas Armadas
NA, Azinhaga Dos Ulmeiros, 1649-020, Lisbon
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti
Clinica Diabet I, Strada Movila Ion 5-7, 020475, Bucharest
Diabet Med S.R.L.
NA, Calea Rahovei No 322d, 050913, Bucharest
Cabinet Medical Dr Geru S.R.L.
NA, Aleea Lirei Nr 1, Ap. 2, Timisoara
Sc Cmi Dr. Pletea Noemi S.R.L.
NA, Strada Stadionului Nr 3a Parter, 600154, Bacau
Medical Practice S.R.L.
NA, Ground Floor, Strada Ingusta 2, Oradea
Nutrilife S.R.L.
NA, Strada Dobrogeanu-Gherea Constantin 10-12, 013764, Bucharest
Spital Judetean De Urgenta Satu Mare
Cardiologie, Piata Eroilor Revolutiei 1-2, 440055, Satu Mare
Poli Cardinal Med S.R.L.
NA, Strada Cardinal Alexandru Todea Nr. 22, 545300, Reghin
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 |
|---|---|---|---|---|---|
| Bulgaria | 2026-05-27 | ||||
| Croatia | 2026-06-01 | ||||
| Germany | 2026-06-01 | 2026-06-02 | |||
| Hungary | 2026-05-27 | ||||
| Poland | 2026-05-28 | 2026-06-03 | |||
| Portugal | 2026-05-29 | ||||
| Romania | 2026-05-29 | 2026-06-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 72 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | d1_nn9490-8028-protocol-2024-520446-31-english_for-publication | 3 |
| Protocol (for publication) | d4_nn9490-8028-patient-facing-material-with-copyright_for-publication | 1 |
| Recruitment arrangements (for publication) | k1_bg_nn9490-8028-recruitment-arrangements_for-publication | 2 |
| Recruitment arrangements (for publication) | k1_de_nn9490-8028-recruitment-arrangements-english_for-publication | 1 |
| Recruitment arrangements (for publication) | k1_hr_nn9490-8028-recruitment-arrangements-english_for-publication | 1.0 |
| Recruitment arrangements (for publication) | k1_hu_nn9490-8028-recruitment-arrangements-english_for-publication | 1.0 |
| Recruitment arrangements (for publication) | k1_pl_nn9490-8028-recruitment-arrangements-polish_for-publication | 1 |
| Recruitment arrangements (for publication) | k1_pt_nn9490-8028-recruitment-arrangements-english_for-publication | 1 |
| Recruitment arrangements (for publication) | k1_ro_nn9490-8028-recruitment-arrangements-Romanian_for-publication | 1 |
| Recruitment arrangements (for publication) | k2_de_nn9490-8028-recruitment-material-data-protection-declaration-vendor-german-_for-publication | 3 |
| Recruitment arrangements (for publication) | k2_de_nn9490-8028-recruitment-material-ec-dossier-frame-german-_for-publication | 2 |
| Recruitment arrangements (for publication) | k2_de_nn9490-8028-recruitment-material-flyer-content-german-_for-publication | 3 |
| Recruitment arrangements (for publication) | k2_de_nn9490-8028-recruitment-material-flyer-layout-german-_for-publication | 3 |
| Recruitment arrangements (for publication) | k2_de_nn9490-8028-recruitment-material-google-ads-campaign-german-_for-publication | 1 |
| Recruitment arrangements (for publication) | k2_de_nn9490-8028-recruitment-material-meta-ads-campaign-german-_for-publication | 1 |
| Recruitment arrangements (for publication) | k2_de_nn9490-8028-recruitment-material-online-questionnaire-german-_for-publication | 1 |
| Recruitment arrangements (for publication) | k2_de_nn9490-8028-recruitment-material-patient-information-service-german-_for-publication | 1 |
| Recruitment arrangements (for publication) | k2_de_nn9490-8028-recruitment-material-pi-to-patient-patient-letter-content-german-_for-publication | 1 |
| Recruitment arrangements (for publication) | k2_de_nn9490-8028-recruitment-material-pi-to-patient-patient-letter-layout-german-_for-publication | 1 |
| Recruitment arrangements (for publication) | k2_de_nn9490-8028-recruitment-material-pi-to-physician-doctors-letter-content-german-_for-public | 1 |
| Recruitment arrangements (for publication) | k2_de_nn9490-8028-recruitment-material-pi-to-physician-doctors-letter-layout-german-_for-public | 1 |
| Recruitment arrangements (for publication) | k2_de_nn9490-8028-recruitment-material-recruitment-poster-german-_for-publication | 2 |
| Recruitment arrangements (for publication) | k2_de_nn9490-8028-recruitment-material-video-script-german-_for-publication | 1 |
| Recruitment arrangements (for publication) | k2_de_nn9490-8028-recruitment-material-website-german-_for-publication | 1 |
| Recruitment arrangements (for publication) | k2-bg-nn9490-8028-recruitment-advertisement-recruitment-poster_for-publication | 1.0 |
| Recruitment arrangements (for publication) | k2-hr-nn9490-8028-recruitment-advertisement-recruitment-poster-croatian-for-publication | 1.0 |
| Recruitment arrangements (for publication) | k2-hu-nn9490-8028-recruitment-advertisement-recruitment-poster-hungarian-for-publication | 3 |
| Recruitment arrangements (for publication) | k2-pl-nn9490-8028-recruitment-advertisement-poster-polish-for-publication | 1 |
| Recruitment arrangements (for publication) | k2-pt-nn9490-8028-recruitment-advertisement-poster-portuguese-for-publication | 1 |
| Recruitment arrangements (for publication) | k2-ro-nn9490-8028-recruitment-advertisement-Poster-Romanian-for-publication | 1 |
| Subject information and informed consent form (for publication) | l1_bg-nn9490-8028-piic-future-research_for-publication | 1.0 |
| Subject information and informed consent form (for publication) | l1_bg-nn9490-8028-piic-future-research-english_for-publication | 1.0 |
| Subject information and informed consent form (for publication) | l1_bg-nn9490-8028-piic-home-delivery_for-publication | 2 |
| Subject information and informed consent form (for publication) | l1_bg-nn9490-8028-piic-home-delivery-english_for-publication | 1.0 |
| Subject information and informed consent form (for publication) | l1_bg-nn9490-8028-piic-main-_for-publication | 3 |
| Subject information and informed consent form (for publication) | l1_bg-nn9490-8028-piic-main-english_for-publication | 1.0 |
| Subject information and informed consent form (for publication) | l1_bg-nn9490-8028-piic-partner_for-publication | 1.0 |
| Subject information and informed consent form (for publication) | l1_bg-nn9490-8028-piic-partner-english-_for-publication | 1.0 |
| Subject information and informed consent form (for publication) | l1_de-nn9490-8028-piic-future-research-german-_for-publication | 2 |
| Subject information and informed consent form (for publication) | l1_de-nn9490-8028-piic-main-adult-german-_for-publication | 3 |
| Subject information and informed consent form (for publication) | l1_de-nn9490-8028-piic-partner-german-_for-publication | 2 |
| Subject information and informed consent form (for publication) | l1_hr-nn9490-8028-piic-dtp-_for-publication | 2 |
| Subject information and informed consent form (for publication) | l1_hr-nn9490-8028-piic-future-research-_for-publication | 2 |
| Subject information and informed consent form (for publication) | l1_hr-nn9490-8028-piic-main-adult_for-publication | 2 |
| Subject information and informed consent form (for publication) | l1_hr-nn9490-8028-piic-male-partner-_for-publication | 2 |
| Subject information and informed consent form (for publication) | l1_hr-nn9490-8028-piic-pregnant-participant-_for-publication | 2 |
| Subject information and informed consent form (for publication) | l1_hu-nn9490-8028-piic-future-and-genetic-consent-_for-publication | 1.0 |
| Subject information and informed consent form (for publication) | l1_hu-nn9490-8028-piic-future-and-genetic-information-_for-publication | 1.0 |
| Subject information and informed consent form (for publication) | l1_hu-nn9490-8028-piic-home-delivery-_for-publication | 1.0 |
| Subject information and informed consent form (for publication) | l1_hu-nn9490-8028-piic-main-adult-_for-publication | 2 |
| Subject information and informed consent form (for publication) | l1_hu-nn9490-8028-piic-partner-_for-publication | 1.0 |
| Subject information and informed consent form (for publication) | l1_pl-nn9490-8028-piic-dtp_for-publication | 1 |
| Subject information and informed consent form (for publication) | l1_pl-nn9490-8028-piic-future-research-_for-publication | 2 |
| Subject information and informed consent form (for publication) | l1_pl-nn9490-8028-piic-main_for-publication | 2 |
| Subject information and informed consent form (for publication) | l1_pl-nn9490-8028-piic-male partner-_for-publication | 2 |
| Subject information and informed consent form (for publication) | l1_ro-nn9490-8028-piic-future-research-_for-publication | 1 |
| Subject information and informed consent form (for publication) | l1_ro-nn9490-8028-piic-home-delivery-_for-publication | 1 |
| Subject information and informed consent form (for publication) | l1_ro-nn9490-8028-piic-main-adult-_for-publication | 1 |
| Subject information and informed consent form (for publication) | l1_ro-nn9490-8028-piic-male-partner-_for-publication | 1 |
| Subject information and informed consent form (for publication) | l1-pt-nn9490-8028-piic-dtp-for-publication | 1 |
| Subject information and informed consent form (for publication) | l1-pt-nn9490-8028-piic-future-research-for-publication | 1 |
| Subject information and informed consent form (for publication) | l1-pt-nn9490-8028-piic-main -for-publication | 1 |
| Subject information and informed consent form (for publication) | l1-pt-nn9490-8028-piic-partner-for-publication | 1 |
| Subject information and informed consent form (for publication) | l1-pt-nn9490-8028-piic-pregnancy-and-newborn-for-publication | 1 |
| Subject information and informed consent form (for publication) | l2_hu-nn9490-8028-other-subject-information-material_patient-card-_for-publication | 2.0 |
| Synopsis of the protocol (for publication) | d1_bg_nn9490-8028-protocol-synopsis-2024-520446-31-bulgarian-_for-publication | 1 |
| Synopsis of the protocol (for publication) | d1_hr_nn9490-8028-protocol-synopsis-2024-520446-31-croatian-_for-publication | 1 |
| Synopsis of the protocol (for publication) | d1_hu_nn9490-8028-protocol-synopsis-2024-520446-31-hungarian-_for-publication | 1 |
| Synopsis of the protocol (for publication) | d1_nn9490-8028-protocol-synopsis-2024-520446-31-english_for-publication | 1 |
| Synopsis of the protocol (for publication) | d1_pl_nn9490-8028-protocol-synopsis-2024-520446-31-polish-_for-publication | 1 |
| Synopsis of the protocol (for publication) | d1_pt_nn9490-8028-protocol-synopsis-2024-520446-31-portuguese-_for-publication | 1 |
| Synopsis of the protocol (for publication) | d1_ro_nn9490-8028-protocol-synopsis-2024-520446-31-romanian-_for-publication | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-02 | Germany | Acceptable 2026-05-13
|
2026-05-15 |