Assessing the Impact of Muvalaplin on Major Cardiovascular Events in Adults With Elevated Lipoprotein(a) ( MOVE-Lp(a) )

2025-521067-13-00 Protocol J2O-MC-EKBG Therapeutic confirmatory (Phase III) Ongoing, recruitment ended

Start 24 Apr 2026 · Status Ongoing, recruitment ended · 14 EU/EEA countries · 279 sites · Protocol J2O-MC-EKBG

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruitment ended
Participants planned 10,450
Countries 14
Sites 279

Atherosclerotic Cardiovascular Disease (ASCVD)

To evaluate whether muvalaplin is superior to placebo in reducing the risk of the composite endpoint of MACE-4.

Key facts

Sponsor
Eli Lilly & Co.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14]
Trial duration
24 Apr 2026 → ongoing
Decision date (initial)
2025-10-20
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2025-521067-13-00
WHO UTN
U1111-1322-3786

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacogenomic, Pharmacodynamic, Therapy, Efficacy, Pharmacoeconomic, Pharmacokinetic

To evaluate whether muvalaplin is superior to placebo in reducing the risk of the composite endpoint of MACE-4.

Conditions and MedDRA coding

Atherosclerotic Cardiovascular Disease (ASCVD)

Regulatory references

Scientific advice from competent authorities
European Medicines Agency
Plan to share IPD
Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

  1. Have Lp(a) levels of 175 nmol/L or higher
  2. Meet one of the following criteria: • Have had a previous heart-related event, such as a heart attack, stroke, or a procedure to restore blood flow to the heart or other parts of the body • Be at risk for a first heart-related event, defined by one or more of the following: • Coronary artery disease (CAD), carotid stenosis, or peripheral artery disease (PAD) without a previous heart-related event • A high coronary artery calcium (CAC) score • Reduced kidney function with diabetes • Combination(s) of high risk factors

Exclusion criteria 6

  1. Have had a major heart or blood vessel event within 90 days before screening
  2. Be planning any heart or artery surgery
  3. Have very high blood pressure or have serious heart failure
  4. Have had or planning to have a procedure to remove cholesterol from the blood within 90 days of screening
  5. Have severe kidney failure
  6. Have a history of cancer within 5 years before screening

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Time to First Occurrence of Any Component of the Major Adverse Cardiac Event (MACE)-4 Composite Endpoint

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Muvalaplin

PRD12097099 · Product

Active substance
Muvalaplin
Substance synonyms
LY3473329, (2S,2'S,2''S)-3,3',3''-((nitrilotris(methylene))tris(benzene-3,1-diyl))tris(2-((R)-pyrrolidin-3-yl)propanoic acid)
Pharmaceutical form
TABLET
Route of administration
ORAL USE
Max daily dose
0 Other
Max total dose
0 Other
Max treatment duration
63 Month(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Placebo 1

Placebo to match LY

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

Eli Lilly & Co.

137 Total trials 45 Recruiting 84 Ended
Commercial
Sponsor organisation
Eli Lilly & Co.
Address
1 Lilly Corporate Center
City
Indianapolis
Postcode
46285-0001
Country
United States

Scientific contact point

Organisation
Eli Lilly & Co.
Contact name
Lilly Clinical Trials information desk

Public contact point

Organisation
Eli Lilly & Co.
Contact name
Lilly Clinical Trials information desk

Third parties 17

OrganisationCity, countryDuties
LabCorp Drug Development, Inc.
ORL-000014850
 Meyrin/Geneva, Switzerland Laboratory analysis
Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.
ORG-100043119
 Shanghai, China Laboratory analysis
Icon (Lr) Limited
ORG-100042612
 Dublin 18, Ireland Other
Bioagilytix Labs LLC
ORG-100013030
 Durham, United States Laboratory analysis
Trialbee AB
ORG-100051369
 Malmo, Sweden Other
Greenphire LLC
ORG-100041621
 King Of Prussia, United States Other
Labcorp Development (Asia) Pte Ltd
ORG-100050418
 Singapore, Singapore Laboratory analysis
Iqvia Biotech LLC
ORG-100008704
 Durham, United States On site monitoring
Labcorp Early Development Laboratories Inc.
ORG-100012865
 Madison, United States Laboratory analysis
Veeva Systems Inc.
ORG-100006053
 Pleasanton, United States Data management
Pharmaserve Lilly S.A.C.I.
ORG-100005347
 Kifisia, Greece On site monitoring, Code 12, Other, Code 2, Code 5
RWS Life Sciences Inc.
ORG-100042348
 East Hartford, United States Other
Cleveland Clinic Foundation
ORG-100028017
 Cleveland, United States Code 11
Icon Clinical Research Limited
ORG-100008322
 Dublin 18, Ireland Other
Labcorp Central Laboratory Services LP
ORG-100032236
 Indianapolis, United States Laboratory analysis
Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd.
ORG-100043119
 Shanghai, China Laboratory analysis
Clariness GmbH
ORG-100045306
 Hamburg, Germany Other

Locations

14 EU/EEA countries · 279 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ongoing, recruitment ended 220 18
Belgium Ongoing, recruitment ended 205 21
Czechia Ongoing, recruitment ended 130 17
Denmark Ongoing, recruitment ended 50 3
France Ongoing, recruitment ended 105 16
Germany Ongoing, recruitment ended 550 40
Greece Ongoing, recruitment ended 145 11
Hungary Ongoing, recruitment ended 125 15
Italy Ongoing, recruitment ended 130 17
Netherlands Ongoing, recruitment ended 215 19
Poland Ongoing, recruitment ended 205 21
Romania Ongoing, recruitment ended 175 25
Slovakia Ongoing, recruitment ended 115 13
Spain Ongoing, recruitment ended 790 43
Rest of world
Argentina, India, Australia, United Kingdom, Canada, Taiwan, Brazil, United States, China, Korea, Republic of, Mexico, Japan
 — 7,290 —

Investigational sites

Austria

18 sites · Ongoing, recruitment ended
Medical University Of Vienna
Department of Internal Medicine II, Division of Cardiology, Waehringer Guertel 18-20, Alsergrund, Vienna
Konvent Der Barmherzigen Brueder
Internal Medicine, Seilerstaette 2, 4020, Linz
NOE Landesgesundheitsagentur
Internal Medicine I, Liechtensteinstrasse 67, 2130, Mistelbach
Klinik Landstrasse
1st Medical Department, Juchgasse 25, Landstrasse, Vienna
A.O. Krankenhaus St. Josef Braunau GmbH
Internal Medicine I, Ringstrasse 60, 5280, Braunau Am Inn
imed St. Poelten Gruppenpraxis fuer Innere Medizin Dr. Angermayr Dr. Bobacz Dr. Kastl und Dr. Speidl OG
imed St. Pölten, Kremser Landstrasse 20, 3100, St. Poelten
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Department of Internal Medicine II, Muellner Hauptstrasse 48, 5020, Salzburg
Stadt Wien Wiener Gesundheitsverbund
Karl Landsteiner Institute for Cardiovascular and Critical Care Research, Bruenner Strasse 68, Floridsdorf, Vienna
Klinik Hietzing
Karl Landsteiner Institute for Metabolic Disease and Nephrology, Wolkersbergenstrasse 1, Hietzing, Vienna
Zentrum Fur Klinische Studien Dr. Hanusch GmbH
Zentrum für klinische Studien Dr. Hanusch GmbH, Gumpendorfer Strasse 95/9, Mariahilf, Vienna
Medizinische Universität Graz
Department of Internal Medicine, Division of Endocrinology and Diabetology, Auenbruggerplatz 15, Graz, Graz
Imed19-Privat
Imed19 privat, Chimanistrasse 1, Doebling, Vienna
Ordensklinikum Linz GmbH
Department of Internal Medicine 2 - Cardiology, Angiology and Intensive Care, Fadingerstrasse 1, 4020, Linz
Medical University Of Vienna
Department of Internal Medicine III, Division of Endocrinology and Metabolism, Waehringer Guertel 18-20, Alsergrund, Vienna
Noe LGA Gesundheit Region Mitte GmbH
Internal Medicine 1, Dunant-Platz 1, 3100, St. Poelten
Cardio Metabolic Centre
Cardio Metabolic Centre, Hauptplatz 3/1/1.10, Mattersburg, Mattersburg
Dr. Distelmaier & Dr. Goliasch Gruppenpraxis Fuer Innere Medizin Und Kardiologie OG
Internal Medicine and Cardiology, Theresiengasse 43/7, 1180, Vienna
Vivit
VIVIT - Vorarlberg Institute for Vascular Investigation and Treatment, Carinagasse 47, 6800, Feldkirch

Belgium

21 sites · Ongoing, recruitment ended
Pneumocare
Private Research, Chaussee De Marche 571, 5101, Namur
Az St-Jan Brugge-Oostende A.V.
Cardiology, Ruddershove 10, 8000, Brugge
Algemeen Ziekenhuis Groeninge
Cardiology, President Kennedylaan 4, 8500, Kortrijk
Cliniques Universitaires Saint-Luc
Nephrology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Anima
Anima, Alkerstraat 28, 3570, Alken
Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann
Cardiology, Arthur Van Gehuchtenplein 4, 1020, Brussels
Universitair Ziekenhuis Antwerpen
Cardiology, Drie Eikenstraat 655, 2650, Edegem
Ziekenhuis Aan De Stroom
HartCentrum, Lindendreef 1, 2020, Antwerp
Imelda
Associatie Dialyse Endocrinologie, Wolzakken 22, Imelda GI Clinical Research Center, Antwerpen
Meclinas
Meclinas, Stationsstraat 102-108, 2800, Mechelen
Kormont
Kormont, Kwaremontplein 45, 9690, Kluisbergen
Emmaues
Cardiology, Liersesteenweg 435, 2800, Mechelen
Algemeen Ziekenhuis Klina
Cardiology, Augustijnslei 100, 2930, Brasschaat
Azorg
Endocrinology, Moorselbaan 164, 9300, Aalst
UZ Leuven
Endocrinology, Herestraat 49, 3000, Leuven
CHC MontLegia
Cardiology, Boulev. De Patience Et Beajonc 2, 4000, Liege
Jan Yperman Ziekenhuis
Endocrinologie-Diabetologie, Briekestraat 12, 8900, Ieper
Inokura
Private Research, Avenue De L'Hopital 1, 4000, Liege
Algemeen Ziekenhuis Delta
Cardiology, Deltalaan 1, 8800, Roeselare
Ziekenhuis Oost Limburg
Cardiology, Synaps Park 1, 3600, Genk
Algemeen Ziekenhuis Oostende
Cardiology, Gouwelozestraat 100, 8400, Ostend

Czechia

17 sites · Ongoing, recruitment ended
INTENDIA klinika s.r.o.
NA, Palackeho Trida 198, 537 01, Chrudim
Corintez s.r.o.
NA, Seydlerova 2451/8, Stodulky, Prague 13
Pratia Pardubice a.s.
NA, Trida Miru 2800, Zelene Predmesti, Pardubice I
Cardio Research s.r.o.
NA, J. A. Bati 5645, 760 01, Zlin
DIKa centrum s.r.o.
NA, Karvinska 1518/5, Mesto, Havirov
Kardiologie Stribrny s.r.o.
NA, Koliste 141/47, Zabrdovice, Brno
MUDr. Buchta s.r.o.
NA, Hviezdoslavova 452/18, Radvanice, Ostrava
Diabet2 s.r.o.
NA, Revolucni 765/19, Stare Mesto, Prague 1
MUDr. Karel Kamenik s.r.o.
Kardiologická ambulance, Kridlovicka 55, Stare Brno, Brno-Stred
Clinoxus s.r.o.
NA, Antala Staska 1670/80, Krc, Prague 4
MUDr. Simon Jirat s.r.o.
NA, Lukesova 1514/65, Krc, Prague
Cevni lekarstvi s.r.o.
NA, 21. Dubna 60/21, 747 20, Vresina
Fakultni Nemocnice Hradec Kralove
NA, Sokolska 581, Novy Hradec Kralove, Hradec Kralove
Kardiologicka ambulance Brno s.r.o.
NA, Dobrovskeho 2199/23, Kralovo Pole, Brno-Kralovo Pole
Dr. Haus. s.r.o.
NA, T. G. Masaryka 205, 381 01, Latran
CTC Hodonin s.r.o.
NA, Kollarova 4338/9, 695 01, Hodonin
Kardio Chlumec s.r.o.
NA, Nadrazni 328, Chlumec Nad Cidlinou IV, Chlumec Nad Cidlinou

Denmark

3 sites · Ongoing, recruitment ended
Sanos A/S
Department of Cardiology and Endocrinology, Herlev Hovedgade 82, 2730, Herlev
Sanos A/S
N/A, Borgergade 39, 9362, Gandrup
Sanos A/S
N/A, Boulevarden 19g, 7100, Vejle

France

16 sites · Ongoing, recruitment ended
Centre Hospitalier Saint Joseph Saint Luc
Endocrinologie, 20 Quai Claude Bernard, 69007, Lyon
Centre Hospitalier Regional Universitaire De Tours
Néphrologie, 2 Boulevard Tonnelle, 37000, Tours
CHU Strasbourg-Hautepierre
Medecine Interne, Endocrinologie et Nutrition, 1 Avenue Moliere, Elevator B /Floor 11, Alsace
Hopital Saint Antoine
Service de cardiologie, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
CHU Rangueil
Diabétologie, maladies métaboliques et nutrition, 1, Avenue du Professeur Jean Poulhès,, Toulouse
Centre Hospitalier Universitaire de Poitiers
Centre Cardio Vasculaire, 2 Rue de la Milétrie, Centre Cardio Vasculaire, Vienne
Centre Hospitalier Universitaire De Nice
Service cardiologie, 30 Voie Romaine, 06000, Nice
Pitié Salpêtrière University Hospital
Cardiovascular Prevention Unit, 83, Boulevard de l'Hôpital, Paris
Centre Hospitalier Universitaire De Dijon
Endocrinologie-Diabétologie, 2 Boulevard Mal De Lattre De Tassigny, 21000, Dijon
Centre Hospitalier Universitaire De Lille
Médecine interne, Rue Michel Polonovski, 59037, Lille Cedex
Assistance Publique Hopitaux De Paris
Service de Nutrition, 20 Rue Leblanc, 75015, Paris
Chu Grenoble Alpes
DUNE - Néphrologie, Boulevard de la Chantourne, Isère, Isère
Centre Hospitalier Annecy Genevois
Endocrinologie, 1 Avenue De L Hopital, Bp 90074, Epagny Metz Tessy
Centre Hospitalier Universitaire De Saint Etienne
Medecine Vasculaire et Thérapeutique, Avenue Albert Raimond, 42270, Saint Priest En Jarez
Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes
CIC Endocrinology-Diabetology-Nutrition, Boulevard Professeur Jacques Monod, Hôpital Nord-Laennec, Nantes Cedex 1
Hôpital Bichat - Claude-Bernard
Cardiology Department, 46 Rue Henri Huchard,, 75018, Paris

Germany

40 sites · Ongoing, recruitment ended
Uhz Klinische Forschung
N/A, Unterstrasse 75, Frintrop, Essen
Klinische Forschung Hannover-Mitte GmbH
N/A, Schillerstrasse 30, Mitte, Hanover
Medical Center - University Of Freiburg
Klinik für Kardiologie & Angiologie Studienzentrum Kardiologie, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Hausaerztlich-Kardiologisches MVZ Am Felsenkeller GmbH
N/A, Haus A, Enderstrasse 59, Dresden
Evangelisches Krankenhaus Witten gGmbH
N/A, Pferdebachstrasse 27-43, Mitte, Witten
Universitaetsklinikum Aachen AöR
Klinik für Kardiologie, Angiologie und Internistische Intensivmedizin (Med. Klinik I), Pauwelsstrasse 30, 52074, Aachen
Nephrologisches Zentrum Göttingen GbR
N/A, An Der Lutter 24, 37075, Göttingen
Zentrum für klinische Studien Bad Homburg
N/A, Louisenstrasse 63, 61348, Bad Homburg
MVZ CCB Frankfurt Und Main-Taunus GbR
N/A, Im Pruefling 23, Bornheim, Frankfurt Am Main
FutureMeds GmbH
N/A, Platz Der Deutschen Einheit 4, 63065, Offenbach Am Main
FutureMeds GmbH
N/A, Wilmersdorfer Strasse 79, Charlottenburg, Berlin
Klinische Forschung Schwerin GmbH
N/A, Friedrichstrasse 1, Altstadt, Schwerin
Kardiologische Praxis Dr. med. univ. Wolfgang Jungmair
N/A, Louisenstrasse 63, Bad Homburg, Bad Homburg
Deutsches Herzzentrum Muenchen Klinikum Der Technischen Universitaet Muenchen
Cardiology, Lazarettstrasse 36, Neuhausen-Nymphenburg, Munich
Universitaetsklinikum Heidelberg AöR
Cardiology, Angiology and Pneumology, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
University Of Luebeck
Institut für Endokrinologie und Diabetes, Ratzeburger Allee 160, Strecknitz, Luebeck
Universitaetsklinikum Regensburg AöR
Institut Für Klinische Chemie und Laboratoriumsmedizin, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Herzzentrum Leipzig GmbH
N/A, Struempellstrasse 39, Probstheida, Leipzig
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
N/A, Markt 15, 23758, Oldenburg In Holstein
Klinische Forschung Karlsruhe GmbH
N/A, Rueppurrer Strasse 52, Suedstadt, Karlsruhe
Kardiologische Praxen im Spreebogen
N/A, Alt-Moabit 101 B, 10559, Berlin
Universitaet Leipzig
Cardiology, Liebigstrasse 20, Zentrum-Suedost, Leipzig
Facharztzentrum Dresden-Neustadt Betriebsgesellschaft mbH
N/A, Forststrasse 3, Radeberger Vorstadt, Dresden
Universitätsmedizin Greifswald
Innere Medizin B, Ferdinand-Sauerbruch-Straße 10, 17475, Greifswald
Ze:ro Praxen MVZ für Herz-und Lungenkrankheiten
N/A, Georg-Lechleiter Platz 3, 68165, Mannheim
Klinische Forschung Dresden GmbH
N/A, Prager Strasse 10, Seevorstadt-Ost/Grosser Garten, Dresden
Klinische Forschung Hamburg GmbH
N/A, Hoheluftchaussee 18, Hoheluft-Ost, Hamburg
Otto-von-Guericke-Universität Magdeburg
Lipidambulanz Uniklinikum Magdeburg, Leipziger Strasse 44, Haus39, Magdeburg
Charité Campus Virchow-Klinikum Lipidambulanz
N/A, Augustenburger Platz 1 ,, 2. OG, Berlin
Praxis Oedeme
N/A, Auf der Höhe 69, Lüneburg, Lüneburg
Herzzentrum Dresden GmbH Universitaetsklinik
N/A, Fetscherstrasse 76, Johannstadt-Nord, Dresden
Velocity Clinical Research Germany GmbH
N/A, Spitalerstrasse 4, 20095, Hamburg
St. Josefskrankenhaus Heidelberg GmbH
Klinisches Studienzentrum, Landhausstrasse 25, Weststadt, Heidelberg
Institut fuer Diabetesforschung Muenster GmbH
N/A, Hohenzollernring 70, Herz-Jesu, Muenster
ClinPhenomics CVC GmbH
N/A, Schaumainkai 101-103, Sachsenhausen, Frankfurt Am Main
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH
MVZ Rheumatologie und Autoimmunmedizin, Moenckebergstrasse 27, Hamburg-Altstadt, Hamburg
Cardiologicum Hamburg GbR
N/A, Schlossstrasse 12, Marienthal, Hamburg
Cardiologicum Herzklinik Ulm MVZ GmbH
N/A, Magirusstrasse 49, Weststadt, Ulm
Klinische Forschung Berlin-Mitte GmbH
N/A, Georgenstrasse 24, Mitte, Berlin
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Universitätsstudienzentrum für Stoffwechselerkrankungen, 43 Blasewitzer Straße, EG,, Dresden

Greece

11 sites · Ongoing, recruitment ended
Athens Medical Center S.A.
Department of Internal Medicine, Pylea, Asklipiou 10, Thessaloniki
Geniko Nosokomeio Nikaias Peiraia Ag. Panteleimon Geniko Nosokomeio Dytikis Attikis I
3rd Internal Medicine Department & Diabetes Center, Dimitrios Mantouvalos Str. 3, 184 54, Νikaia
Euromedica General Clinic Of Thessaloniki
Endocrinology Diabetes & Metabolism Department, Kallas Marias 11, Gravias 2, Thessaloniki
Ippokratio General Hospital Of Thessaloniki
Endocrinology Department, Konstadinoupoleos 49, 546 42, Thessaloniki
General University Hospital Of Patras
Department of Endocrinology, Rio, 265 04, Patras
University General Hospital Of Thessaloniki Ahepa
1st Cardiology Clinic, 1st St Kiriakidis Str, 546 36, Thessaloniki
General Hospital Of Thessloniki G Gennimatas
Internal Medicine Clinic, Ethnikis Aminis 41, 546 35, Thessaloniki
University General Hospital Of Ioannina
2nd Department of Internal Medicine, Niarchou Stavrou Avenue, 455 00, Ioannina
Evangelismos S.A.
Department of Endocrinology, Ipsiladou 45-47, 106 76, Athens
University General Hospital Of Heraklion
Department of Internal Medicine, Stavrakia And Voutes, 715 00, Heraklion
Athens Medical Center S.A.
Internal Medicine Clinic, Adersen 1, 115 25, Athens

Hungary

15 sites · Ongoing, recruitment ended
Arina Trial Research Kft.
N/A, Kigyo Utca 24, 5900, Oroshaza
University Of Szeged
Belgyogyaszati Klinika Deli Telephely, Semmelweis Utca 8, 6725, Szeged
Medifarma-98 Kft.
N/A, Praga Utca 9, 4400, Nyiregyhaza
Eszak-Pesti Centrumkorhaz-Honvedkorhaz
II. Belgyogyaszat, Podmaniczky utca 111, 1062, Budapest
Semmelweis University
N/A, Varosmajor Utca 68, Kerulet, Budapest XII
Obudai Egeszseguegyi Centrum Kft.
N/A, Lajos Utca 74-76, 1036, Budapest III
University Of Szeged
Csaladorvosi Intezet es Rendelo, Tisza Lajos Korut 109, 6725, Szeged
Semmelweis University
Kardiologiai rehab. reszleg, Gyulai Pal Utca 2, Kerulet, Budapest VIII
Central Hospital Of Northern Pest Military Hospital
Kardiologiai Osztaly, Robert Karoly Korut 44, 1134, Budapest XIII
University Of Szeged
Belgyogyaszati Klinika Nyugati Telephely, Kalvaria Sugarut 57, 6725, Szeged
Cardiogeneral Kft.
N/A, Bonyhadi Ut 127, 1141, Budapest XIV
Coromed-Smo Kft.
N/A, Jaszai Mari Utca 3, 7623, Pecs
Vita Verum Medical Bt.
N/A, Fiskalis Ut 43, 8000, Szekesfehervar
Gottsegen National Cardiovascular Center
N/A, Kerulet, Haller Utca 29/IX., Budapest
KomplexLabor Kft.
N/A, Kenyergyari Ut 8, 6724, Szeged

Italy

17 sites · Ongoing, recruitment ended
IRCCS Ospedale Policlinico San Martino
Internal Medicine, Largo Rosanna Benzi 10, 16132, Genoa
Azienda Ospedaliero Universitaria S.Anna
Centro dello Scompenso, Via Aldo Moro 8, 44100, Ferrara
Azienda Ospedaliero Universitaria Di Modena
Reparto di Medicina Metabolica, Via Pietro Giardini 1355, 41126, Modena
Ospedale San Raffaele S.r.l.
Unità Cardio-Metabolica, Via Olgettina 60, 20132, Milan
Hospital Santa Maria Della Misericordia
Department of Medicine and Surgery,Section of Internal Medicine,Angiology and Atherosclerosis Diseas, Piazzale Giorgio Menghini 1, 06129, Perugia
ASST Grande Ospedale Metropolitano Niguarda
Unità Ricerche Cliniche della Cardiologia 4, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Fondazione Toscana Gabriele Monasterio
Lipoaphereis Unit, Via Giuseppe Moruzzi 1, 56124, Pisa
Azienda Ospedaliera Sant'Anna E San Sebastiano Di Caserta
UOC Cardiologia a Direzione Universitaria, Via Ferdinando Palasciano Snc, 81100, Caserta
University Hospital Of Ferrara
Dipartimento di Medicina Interna, Via Aldo Moro 8, 44124, Ferrara
Azienda Unita Locale Socio Sanitaria N 8 Berica
U.O.C. Cardiologia, Via Del Parco 1, 36071, Arzignano
Azienda Ospedaliero Universitaria Careggi
SOD MALATTIE ATEROTROMBOTICHE, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Internal Medicine, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Dipartimento ProMISE (Department of Health Promotion, Mother and Child Care, Internal Medicine and M, Via Del Vespro 129, 90127, Palermo
Azienda Ospedaliero-Universitaria Sant Andre
Hypertension Unit, Division of Cardiology, Via Di Grottarossa 1035-1039, 00189, Rome
Centro Cardiologico Monzino S.p.A.
diabetology, Via Carlo Parea 4, 20138, Milan
Azienda Ospedaliera di Padova
Department of Medicine-DIMED, Via Nicolo' Giustiniani 2, 35128, Padova
Fondazione IRCCS Policlinico San Matteo
Cardiology, Viale Camillo Golgi 19, 27100, Pavia

Netherlands

19 sites · Ongoing, recruitment ended
Stichting OLVG
Klinische Research Cardiologie, Oosterpark 9, 1091 AC, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Internal Medicine, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Noordwest Ziekenhuisgroep Stichting
Internal Medicine, Wilhelminalaan 12, 1815 JD, Alkmaar
Bravis Ziekenhuis
Internal Medicine, Boerhaaveplein 1, 4624 VT, Bergen Op Zoom
Albert Schweitzer Ziekenhuis
Internal Medicine, Langeweg 336, 3331 LZ, Zwijndrecht
Amsterdam UMC Stichting
Vascular Medicine Clinical Trial Unit, Meibergdreef 9, 1105 AZ, Amsterdam
Wilhelmina Ziekenhuis Assen
Researchbureau, Europaweg-Zuid 1, 9401 RK, Assen
EB FlevoResearch B.V.
General Practice, Louis Armstrongweg 88, 1311 RL, Almere
Bethesda Diabetes Research Center B.V.
Interne geneeskunde, Dr. G.H. Amshoffweg 1, 7909 AA, Hoogeveen
Radboud universitair medisch centrum Stichting
Cardiology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Universitair Medisch Centrum Utrecht
Vascular Medicine Research, Heidelberglaan 100, 3584 CX, Utrecht
Ziekenhuis Gelderse Vallei Stichting
Internal Medicine, Willy Brandtlaan 10, 6716 RP, Ede Gld
PreCare Trial & Recruitment B.V.
Reseach Physician, Elsstraat 47, 6191 JW, Beek Lb
Meander Medisch Centrum
Researchbureau sectie Interne, MDL, Geriatrie, Maatweg 3, 3813 TZ, Amersfoort
Leids Universitair Medisch Centrum (LUMC)
Hartlong Centrum, Albinusdreef 2, 2333 ZA, Leiden
Rijnstate Ziekenhuis Stichting
Vascular Centre, Wagnerlaan 55, 6815 AD, Arnhem
Tergooiziekenhuizen
Interne geneeskunde, Laan Van Tergooi 2, 1212 VG, Hilversum
Canisius Wilhelmina Ziekenhuis
Internal Medicine, Weg Door Jonkerbos 100, 6532 SZ, Nijmegen
Maxima Medisch Centrum
Internal Medicine, De Run 4600, 5504 DB, Veldhoven

Poland

21 sites · Ongoing, recruitment ended
Instytut Centrum Zdrowia Matki Polki
N/A, Ul. Rzgowska 281/289, 93-338, Lodz
Centra Medyczne Medyceusz Sp. z o.o.
N/A, Ul. Bazarowa 9, 91-053, Lodz
Clinical Best Solutions Sp. z o.o. S.K.
N/A, Aleja Jozefa Pilsudskiego 11, 20-011, Lublin
Przychodnie Grudziądz Sp. z o.o.
N/A, ul. Legionów 21/23,, 86-300, Grudziadz
Imedica Centrum Medyczne, Private Practice - Dr. Michał Tomaszewski
N/A, ul. Stanisława Leszczyńskiego 25 lok.U0.09,, 20-068, Lublin
Centrum Medyczne Komorniki Sp. z o.o.
N/A, Ul. Stawna 7, 62-052, Komorniki
Serce Sp. z o.o.
N/A, Ul. Fabryczna 15, 64-100, Leszno
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie
N/A, ul. Jaczewskiego 8,, 20-954, Lubin
Centrum Medyczne "Hipokrates" S.C. Elżbieta i Grzegorz Grześk
N/A, ul. Fryderyka Chopina 11A/2, 85-092, Bydgoszcz
Futuremeds Sp. z o.o.
N/A, Ul. Gruszowa 2, 91-363, Lodz
Gyncentrum Sp. z o.o.
N/A, Ul. Tadeusza Kosciuszki 229, 40-600, Katowice
Salvia Lekston I Madej Sp. j.
N/A, Ul. Panewnicka 201/1, 40-772, Katowice
Futuremeds Sp. z o.o.
N/A, Ul. Legnicka 16, 53-673, Wroclaw
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.
N/A, Ul. Rusznikarska 17, 31-261, Cracow
Niepubliczny Zaklad Opieki Zdrowotnej Twoje Zdrowie El Sp. z o.o.
N/A, Ul. Elizy Orzeszkowej 13, 82-300, Elblag
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.
N/A, Ul. Polskiej Organizacji Wojskowej 12 C, 97-300, Piotrkow Trybunalski
4 Wojskowy Szpital Kliniczny z Polikliniką SPZOZ
N/A, ul. Rudolfa Weigla 5, 50-981, Wroclaw
Pro&Diagnostic
N/A, Ulica Komorowicka 23,, 42-346, Bielsko-Biala
Centrum Szybkiej Diagnostyki Kardiologicznej "Kardiomed" M.Żabówka, E.Żabówka
N/A, Ul. Lwowska 197, 33-100, Tarnów
Linden Sp. z o.o. sp.k.
NA, Ul. Tadeusza Kosciuszki 39/Lu4, 30-105, Cracow
Futuremeds Sp. z o.o.
NA, Ul. Sw. Wincentego 93 Lok. 5/6/7, 03-291, Warsaw

Romania

25 sites · Ongoing, recruitment ended
Nutrilife S.R.L.
Diabetes, Nutrition and Metabolic Diseases, Strada Dobrogeanu-Gherea Constantin 10-12, 013764, Bucharest
Spitalul Clinic Judetean De Urgenta Targu Mures
Cardiology, Strada Marinescu Gheorghe 50, 540136, Targu Mures
Gensan S.R.L.
Diabetes, Nutrition and Metabolic Diseases, Strada Alexandrescu Grigore Nr 1, 550371, Sibiu
Dentosim-Queen S.R.L.
Diabetes, Nutrition and Metabolic Diseases, Strada Mihai Viteazul 27a, 540098, Targu Mures
Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu
Cardiology, 149th Ic Bratianu Street, 077015, Balotesti
Centrul Medical Unirea S.R.L.
Cardiology, Strada Maniu Iuliu Nr 49, 500091, Brasov
Institutul De Boli Cardiovasculare Timisoara
Cardiology, Strada Adam Gheorghe Nr 13a, 300310, Timisoara
Spitalul Universitar De Urgenta Bucuresti
Cardiology, Splaiul Independentei 169, 050098, Bucharest
Mediab S.R.L.
Diabetes, Nutrition and Metabolic Diseases, Apartament I-II, Strada Marinescu Gheorghe Nr 8a, Targu Mures
Nicodiab S.R.L.
Diabetes, Nutrition and Metabolic Diseases, Strada Polona Nr 92, 010507, Bucharest
Mat Cord Biomedica S.R.L.
Cardiology, Strada Titulescu Nicolae 11, 120133, Buzau
Delta Health Care S.R.L.
Cardiology, Strada Caramfil G. Nicolae Nr 85a, 014142, Bucharest
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti
Diabetes, Nutrition and Metabolic Diseases, Strada Caragiale Ion Luca 12-14, 020045, Bucharest
Spitalul Clinic Prof.Dr.Theodor Burghele
Cardiology, Panduri Road 20, District 5, Bucharest
Sanamed Hospital S.R.L.
Diabetes, Nutrition and Metabolic Diseases, Calea Plevnei 159, 060013, Bucharest
Medical Practice S.R.L.
Diabetes, Nutrition and Metabolic Diseases, Ground Floor, Strada Ingusta 2, Oradea
Clinica Korall S.R.L.
Diabetes, Nutrition and Metabolic Diseases, Piata Eroilor Revolutiei, Corp A Apartament M 2 Nr 22, Satu Mare
Milena Sante S.R.L.
Diabetes, Nutrition and Metabolic Diseases, Strada Balcescu Nicolae Nr 31, 800001, Galati
Hightech Medical Services S.R.L.
Diabetes, Nutrition and Metabolic Diseases, Sector 1 Alexandra Ioan Cuza Blvd 76, 011053, Bucharest
CMI Dr. Podoleanu Cristian
Cardiology, Aleea Cornisa, Nr. 5
Cabinet Medical Dr Geru S.R.L.
Diabetes, Nutrition and Metabolic Diseases, Aleea Lirei Nr 1, Ap. 2, Timisoara
Diamed Obesity S.R.L.
Diabetes, Nutrition and Metabolic Diseases, Gheorghe Doja Nr 73, 800291, Galati
Cardioplus Center S.R.L.
Diabetes, Nutrition and Metabolic Diseases, Strada Dulfu Petre 12a, 430124, Baia Mare
Diabet Med S.R.L.
Diabetes, Nutrition and Metabolic Diseases, Calea Rahovei No 322d, 050913, Bucharest
Mediab S.R.L.
Diabetes, Nutrition and Metabolic Diseases, Apartament I-II, Strada Marinescu Gheorghe Nr 8a, Targu Mures

Slovakia

13 sites · Ongoing, recruitment ended
Penta Hospitals SK a.s.
NA, Srobarova 1, 979 01, Rimavska Sobota
Národny ustav srdcovych a cievnych chorob a.s.
NA, Pod Krasnou Horkou 1, Nove Mesto, Bratislava
Diabeda s.r.o.
NA, Tbiliska 6, Raca, Bratislava
Cardio D&R s.r.o. Kosice
NA, Marsala Koneva 1, Dargovskych Hrdinov, Kosice
Premedix
NA, Jelsova 3086/1, 831 01, Bratislava
Nemocnica S Poliklinikou Sv Lukasa Galanta a.s.
NA, Hodska 373/38, 924 01, Galanta
Nemocnica s poliklinikou Stefana Kukuru Michalovce a.s.
NA, Spitalska 2, 071 01, Michalovce
MediVet s.r.o.
NA, Nadrazna 23, 901 01, Malacky
Nemocnica s poliklinikou Spisska Nova Ves a.s.
NA, Jana Janskeho 1, 052 01, Spisska Nova Ves
Vranovska nemocnica a.s.
NA, B 177, M. R. Stefanika 187, Vranov Nad Toplou
Nemocnicna a.s.
NA, Duklianskych Hrdinov 34, 901 01, Malacky
Benimed s.r.o.
NA, Javorova 2882/25, 921 01, Piestany
Nemocnica S Poliklinikou Dunajska Streda a.s.
NA, Velkoblahovska Cesta 23, 929 01, Dunajska Streda

Spain

43 sites · Ongoing, recruitment ended
Hospital Clinic De Barcelona
Clinical Institute of Digestive and Metabolic Diseases, Calle Villarroel 170, 08036, Barcelona
Hospital Quironsalud Malaga
Endocrinologia Y Nutricion, Avenida Imperio Argentina 1, 29004, Malaga
Hospital Infanta Elena
MEDICINA INTERNA, Calle Doctor Pedro Naranjo Sn, 21007, Huelva
Hospital Universitario Miguel Servet
Lipid Unit, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
Salut Sant Joan De Reus
Vascular and Metabolism Unit, Avinguda Del Doctor Josep Laporte 2, 43204, Reus
Bellvitge University Hospital
Unitat de Lipids i Risc Vascular, Carrer De La Feixa Llarga S/N, 08907, L'Hospitalet De Llobregat
Eap Osona Sud Alt Congost S.L.P.
Department, Placa Del Pla Del Mestre 7, 08540, Centelles
Hospital Universitari Vall D Hebron
Endocrinology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Hospital Universitario Ramon Y Cajal
Internal Medicine, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Consorcio Hospital General Universitario De Valencia
Internal Medicine, Avenida Tres Cruces 2, 46014, Valencia
Hospital Universitario De La Princesa
Endocrinología y metabolismo, Calle De Diego De Leon 62, 28006, Madrid
Hospital Civil de Málaga
Internal Medicine, Plaza Del Hospital S/n 29009 Málaga, 29009, Malaga
Hospital Quironsalud Infanta Luisa
Endocrinology, Calle De San Jacinto 87, 41010, Sevilla
Futuremeds Spain S.L.
Departmet, Glorieta De Mejico 1, 41012, Sevilla
Complexo Hospitalario Universitario De Pontevedra
Unidad lípidos/endocrinología, Calle Mourente S/n, 36164, Pontevedra
Hospital Universitario Rio Hortega
Internal Medicine, Calle Dulzaina 2, 47012, Valladolid
Hospital Universitario De Jaen
Internal Medicine, Avenida Del Ejercito Espanol 10, 23007, Jaen
Hospital Universitario Infanta Leonor
Internal Medicine, Avenida Gran Via Del Este 80, 28031, Madrid
Complexo Hospitalario Universitario De Santiago
Cardiology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Futuremeds Spain S.L.
Department, Calle De La Granja 8, 28003, Madrid
Hospital Virgen Del Camino
Internal Medicine, Carretera De Chipiona Sn, 11540, Sanlucar De Barrameda
Hospital Del Mar
Cardiologia, Passeig Maritim De La Barceloneta 25-29, 08003, Barcelona
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
N/A, Calle Alejo Fernandez 9, 41003, Sevilla
Hospital Universitario Reina Sofia
Medicina Interna, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Clinico Universitario De Valencia
Cardiology, Avenida Blasco Ibanez 17, 46010, Valencia
University Hospital Son Espases
Endocrinology, Carretera Valldemossa 79, 07120, Palma
Hospital Universitario Marques De Valdecilla
Endocrinology, Diabetes & Nutrition Department, Avenida Valdecilla Sn, 39008, Santander
Hospital Virgen De Las Montanas
Medicina Interna, Paseo Ambulatorio Sn, 11650, Villamartin
Hospital Universitario Virgen De La Victoria
Endocrinologia y nutricion, Campus De Teatinos Sn, Puerto De La Torre, Malaga
Centro De Salud San Juan De La Cruz
Department, Camino De Alcorcon 8, 28223, Pozuelo De Alarcon
Hospital Universitario 12 De Octubre
Internal Medicine, Avenida De Cordoba Sn, 28041, Madrid
University Hospital Virgen Del Rocio S.L.
Internal Medicine, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital 9 De Octubre S.A.
Cardiology, Calle Valle De La Ballestera 59, 46015, Valencia
Complexo Hospitalario Universitario A Coruna
Internal Medicine, Lugar Jubias De Arriba 84, 15006, A Coruna
Instituto Medico Quirurgico San Rafael S.A.
Endocrinology, Poboado Nucleo Rural La Jubias 82, 15006, A Coruna
Area Sanitaria De Ferrol
ENDOCRINOLOGÍA, Avenida Residencia S/n, 15405, Ferrol
Complejo Hospitalario Ruber Juan Bravo
Endocrinología y Nutrición, Calle De Diego De Velazquez 1 Pozuelo De Alarcon, 28223, Madrid
Hospital Nisa Sevilla Aljarafe
Unidad de Salud Metabólica. Diabetes y Obesidad, Avenida Placido Fernandez Viagas S/n, 41950, Castilleja De La Cuesta
Hospital Universitario De Toledo
Preventive Cardiology Unit, Avenue Del Rio Guadiana Sn, 45007, Toledo
Hospital Universitario Virgen De Las Nieves
Medicina Interna, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Hospital Universitario De Leon
Endocrinology and metabolism, Calle Altos De Nava S/n, 24071, Leon
El Hospital Universitario De Gran Canaria Dr. Negrin
Cardiología, Barranco De La Ballena S N, 35010, Las Palmas De Gran Canaria
Hospital General De Segovia
Endocrinologia y Nutrición, Calle De Luis Erik Claveria, 40002, Segovia

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Austria 2025-10-22 2025-11-12 2026-03-27
Belgium 2025-10-21 2025-11-03 2026-03-27
Czechia 2025-10-14 2025-10-30 2026-03-27
Denmark 2025-11-05 2025-11-10 2026-03-27
France 2025-11-03 2025-11-20 2026-03-27
Germany 2025-10-16 2025-10-28 2026-03-27
Greece 2025-12-18 2025-12-22 2026-03-27
Hungary 2025-10-22 2025-11-10 2026-03-27
Italy 2025-10-24 2025-11-04 2026-03-27
Netherlands 2025-11-11 2025-12-18 2026-03-27
Poland 2025-10-23 2025-11-04 2026-03-27
Romania 2025-10-22 2025-11-07 2026-03-27
Slovakia 2025-10-13 2025-10-28 2026-03-27
Spain 2025-10-24 2025-11-04 2026-03-27

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 14 · Art. 38 CTR

Temporary halt TH-128578

Halt date
2026-03-27
Member states concerned
Denmark
Publication date
2026-04-10
Reason
Study management related
Benefit-risk balance changed
No
Treatment stopped
No

Temporary halt TH-128582

Halt date
2026-03-27
Member states concerned
Germany
Publication date
2026-04-10
Reason
Study management related
Benefit-risk balance changed
No
Treatment stopped
No

Temporary halt TH-128592

Halt date
2026-03-27
Member states concerned
Spain
Publication date
2026-04-10
Reason
Study management related
Benefit-risk balance changed
No
Treatment stopped
No

Temporary halt TH-128584

Halt date
2026-03-27
Member states concerned
Greece
Publication date
2026-04-10
Reason
Study management related
Benefit-risk balance changed
No
Treatment stopped
No

Temporary halt TH-128594

Halt date
2026-03-27
Member states concerned
Netherlands
Publication date
2026-04-10
Reason
Study management related
Benefit-risk balance changed
No
Treatment stopped
No

Temporary halt TH-128572

Halt date
2026-03-27
Member states concerned
Austria
Publication date
2026-04-10
Reason
Study management related
Benefit-risk balance changed
No
Treatment stopped
No

Temporary halt TH-128586

Halt date
2026-03-27
Member states concerned
Hungary
Publication date
2026-04-10
Reason
Study management related
Benefit-risk balance changed
No
Treatment stopped
No

Temporary halt TH-128596

Halt date
2026-03-27
Member states concerned
Poland
Publication date
2026-04-10
Reason
Study management related
Benefit-risk balance changed
No
Treatment stopped
No

Temporary halt TH-128574

Halt date
2026-03-27
Member states concerned
Belgium
Publication date
2026-04-10
Reason
Study management related
Benefit-risk balance changed
No
Treatment stopped
No

Temporary halt TH-128588

Halt date
2026-03-27
Member states concerned
Italy
Publication date
2026-04-10
Reason
Study management related
Benefit-risk balance changed
No
Treatment stopped
No

Temporary halt TH-128598

Halt date
2026-03-27
Member states concerned
Slovakia
Publication date
2026-04-10
Reason
Study management related
Benefit-risk balance changed
No
Treatment stopped
No

Temporary halt TH-128576

Halt date
2026-03-27
Member states concerned
Czechia
Publication date
2026-04-10
Reason
Study management related
Benefit-risk balance changed
No
Treatment stopped
No

Temporary halt TH-128580

Halt date
2026-03-27
Member states concerned
France
Publication date
2026-04-10
Reason
Study management related
Benefit-risk balance changed
No
Treatment stopped
No

Temporary halt TH-128590

Halt date
2026-03-27
Member states concerned
Romania
Publication date
2026-04-10
Reason
Study management related
Benefit-risk balance changed
No
Treatment stopped
No

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 295 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) D1_Protocol 2025-521067-13-00_redacted a
Protocol (for publication) D1_Protocol_2025-521067-13-00_GR_Redacted a
Protocol (for publication) D4_Study Participant Contact Card_GR 1
Recruitment arrangements (for publication) 1_Recruitment and Informed consent procedure_GR 1
Recruitment arrangements (for publication) K1_Appreciation Items 1
Recruitment arrangements (for publication) K1_List of participating sites 1
Recruitment arrangements (for publication) K1_List of sites_Redacted 3
Recruitment arrangements (for publication) K1_Lp a-Infographic_Master 2
Recruitment arrangements (for publication) K1_Recruitment and consenting procedure 1
Recruitment arrangements (for publication) K1_Recruitment and ICF form 1
Recruitment arrangements (for publication) K1_Recruitment and informed consent procedure 1
Recruitment arrangements (for publication) K1_Recruitment and Informed consent procedure 1
Recruitment arrangements (for publication) K1_Recruitment and Informed consent procedure 2
Recruitment arrangements (for publication) K1_Recruitment and Informed consent procedure 1.0
Recruitment arrangements (for publication) K1_Recruitment arrangements 1.0
Recruitment arrangements (for publication) K1_Recruitment arrangements 1.1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment arrangements 1.0
Recruitment arrangements (for publication) K1_Recruitment arrangements 1
Recruitment arrangements (for publication) K1_Recruitment Arrangements_Complete Consent Security and Privacy Quick Reference Guide_Redacted 1.5
Recruitment arrangements (for publication) K1_Recruitment Arrangements_eConsent Submission Letter ENG 1.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_FRA 1.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements_Getting Started Patient facing landing page_Redacted 1.1
Recruitment arrangements (for publication) K1_Recruitment Arrangements_IQVIA Complete Consent Security and Privacy QRG_BEDU_Redacted 1.5
Recruitment arrangements (for publication) K1_Recruitment Arrangements_IQVIA Complete Consent Security and Privacy QRG_BEFR_Redacted 1.5
Recruitment arrangements (for publication) K1_Recruitment Arrangements_IQVIA Complete Consent Security and Privacy QRG_ENG_Redacted 1.5
Recruitment arrangements (for publication) K1_Recruitment arrangements_List of Sites 1
Recruitment arrangements (for publication) K1_Recruitment Arrangements_Meclinas Carousel Post Images_Redacted 4.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements_Meclinas Flyer_Redacted 4.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements_Meclinas Images 2.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements_Meclinas Recruitment Strategy_Redacted 5.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements_Meclinas Slogans_Redacted 4.0
Recruitment arrangements (for publication) K1_Recruitment Arrangements_Participant Facing Screenshots_Redacted 1.4
Recruitment arrangements (for publication) K1_Recruitment arrangements_PL 1.0
Recruitment arrangements (for publication) K1_Recruitment Procedure 1.1
Recruitment arrangements (for publication) K1_recruitment texts_variant 1_FutureMeds GmbH_Site Berlin 1.1
Recruitment arrangements (for publication) K1_recruitment texts_variant 1_FutureMeds GmbH_Site Offenbach_DE_v1 1 1.1
Recruitment arrangements (for publication) K1_recruitment texts_variant 2_FutureMeds GmbH_Site Berlin_DE_v1 1 1
Recruitment arrangements (for publication) K1_recruitment texts_variant 2_FutureMeds GmbH_Site Offenbach 1.1
Recruitment arrangements (for publication) K2_ Recruitment material_Dr to patient letter_redacted 1.1
Recruitment arrangements (for publication) K2_ Recruitment material_flyer 1.1
Recruitment arrangements (for publication) K2_ Recruitment material_poster 1.1
Recruitment arrangements (for publication) K2_ Recruitment material_recruitment brochure_redacted 1.1
Recruitment arrangements (for publication) K2_ Recruitment material_referral letter_redacted 1.1
Recruitment arrangements (for publication) K2_Brochure_Master_RO_Redacted 1
Recruitment arrangements (for publication) K2_EKBG_Brochure_Master_ES_Redacted 1.0
Recruitment arrangements (for publication) K2_EKBG_Flyer_Master_ES 1.0
Recruitment arrangements (for publication) K2_EKBG_Letter-Doctor-Referral_Master_ES_Redacted 1.0
Recruitment arrangements (for publication) K2_EKBG_Letter-Doctor-to-Patient_Master_ES_Redacted 1.0
Recruitment arrangements (for publication) K2_EKBG_Poster_Master_ES 1.0
Recruitment arrangements (for publication) K2_Flyer_Master_RO 1
Recruitment arrangements (for publication) K2_Letter-Doctor-Referral_Master_RO_Redacted 2
Recruitment arrangements (for publication) K2_Letter-Doctor-to-Patient_Master_RO_Redacted 1
Recruitment arrangements (for publication) K2_Poster_Master_RO 1
Recruitment arrangements (for publication) K2_Recruitment Arrangments_Meclinas Website Text_BEDU_Redacted 2.0
Recruitment arrangements (for publication) K2_Recruitment material Brochure_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment material_Appreciation Items 1
Recruitment arrangements (for publication) K2_Recruitment material_Brochure_BEDU_Redacted 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Brochure_BEFR_Redacted 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Brochure_GR_Redacted 2
Recruitment arrangements (for publication) K2_Recruitment material_Brochure_IT Redacted 1
Recruitment arrangements (for publication) K2_Recruitment material_Brochure_Master_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment Material_Brochure_Master_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment material_Brochure_Redacted 1.1
Recruitment arrangements (for publication) K2_Recruitment material_Brochure_Redacted 1.1
Recruitment arrangements (for publication) K2_Recruitment Material_Doctor Referral Letter_FRA_Redacted 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Doctor to Patient Letter_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment Material_Doctor-to-Patient_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment material_EKBG_Brochure_Master_PL_Redacted 1.0
Recruitment arrangements (for publication) K2_Recruitment material_EKBG_Flyer_Master_PL 1.0
Recruitment arrangements (for publication) K2_Recruitment material_EKBG_Letter Doctor to Patient_Master_PL_Redacted 1.0
Recruitment arrangements (for publication) K2_Recruitment material_EKBG_Letter Participant Welcome_Master_PL 1.0
Recruitment arrangements (for publication) K2_Recruitment material_EKBG_Poster_Master_PL 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Flyer 1.1
Recruitment arrangements (for publication) K2_Recruitment material_Flyer 1
Recruitment arrangements (for publication) K2_Recruitment material_Flyer_BEDU 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Flyer_BEFR 1.0
Recruitment arrangements (for publication) K2_Recruitment Material_Flyer_FRA 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Flyer_GR 1.1
Recruitment arrangements (for publication) K2_Recruitment material_Flyer_IT 1
Recruitment arrangements (for publication) K2_Recruitment material_Flyer_Master 1
Recruitment arrangements (for publication) K2_Recruitment Material_For Advertisement_Werbetext 1
Recruitment arrangements (for publication) K2_Recruitment material_Infographic 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Letter Doctor Referral_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment material_Letter Doctor Referral_Site facing_BEDU_Redacted 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Letter Doctor Referral_Site facing_BEFR_Redacted 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Letter Doctor to Patient_GR_Redacted 1.1
Recruitment arrangements (for publication) K2_Recruitment material_Letter Doctor to Patient_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment material_Letter Doctor to Patient_Subject facing_BEDU_Redacted 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Letter Doctor to Patient_Subject facing_BEFR_Redacted 1.0
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Recruitment arrangements (for publication) K2_Recruitment Material_Letter-Doctor-Referral_Redacted 2
Recruitment arrangements (for publication) K2_Recruitment material_Letter-Doctor-to-Patient_Master_Redacted 1
Recruitment arrangements (for publication) K2_Recruitment material_Letter-Doctor-to-Patient_Redacted 1
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Recruitment arrangements (for publication) K2_Recruitment material_Lpa Infographic_Comparison report 2
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Recruitment arrangements (for publication) K2_Recruitment material_Lpa-Infographic BEFR 2.0
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Recruitment arrangements (for publication) K2_Recruitment material_Poster 1
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Recruitment arrangements (for publication) K2_Recruitment material_Poster_BEFR 1.0
Recruitment arrangements (for publication) K2_Recruitment Material_Poster_FRA 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Poster_GR 1.1
Recruitment arrangements (for publication) K2_Recruitment material_Poster_IT 1
Recruitment arrangements (for publication) K2_Recruitment material_Poster_Master 1
Recruitment arrangements (for publication) K2_Recruitment Material_Prescreening Tool Questions 1
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Recruitment arrangements (for publication) K2_Recruitment material_site KF 2
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Recruitment arrangements (for publication) K2_Recruitment Materials_Flyer_Master 1
Recruitment arrangements (for publication) K2_Recruitment Materials_Poster-Master 1
Recruitment arrangements (for publication) K3_Recruitment material Letter-Doctor-To-Patient_Redacted 1
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Recruitment arrangements (for publication) K5_Recruitment material Poster 1
Recruitment arrangements (for publication) K6_Other subject information material eConsent - Participant-Facing Screenshots_Redacted 1.4
Recruitment arrangements (for publication) K6_Other subject information material eConsent Patient-facing landing page_Redacted 1.1
Recruitment arrangements (for publication) K6_Other subject information material eConsent Submission Letter 1
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Subject information and informed consent form (for publication) L1_ SIS and ICF_Addendum Genetic_Redacted 1.0
Subject information and informed consent form (for publication) L1_ SIS and ICF_Addendum optional research PK_Redacted 1.0
Subject information and informed consent form (for publication) L1_ SIS and ICF_Addendum Pre-screening_Redacted 1.0
Subject information and informed consent form (for publication) L1_ SIS and ICF_Main ICF Redacted 1.0
Subject information and informed consent form (for publication) L1_ICF_Main_GR_Redacted 1
Subject information and informed consent form (for publication) L1_Main ICF_RO_Redacted 1
Subject information and informed consent form (for publication) L1_Optional Activity ICF_RO_Redacted 1
Subject information and informed consent form (for publication) L1_Prescreening ICF_GR 1
Subject information and informed consent form (for publication) L1_Prescreening ICF_RO 1
Subject information and informed consent form (for publication) L1_SIS and ICF Main_Redacted 2.3
Subject information and informed consent form (for publication) L1_SIS and ICF Pre-Screening_Redacted 1.4
Subject information and informed consent form (for publication) L1_SIS and ICF_Addendum Optional Activity_Redacted 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Addendum Prescreening 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Addendum Prescreening_TC 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Confidentiality Notice for TLC 1
Subject information and informed consent form (for publication) L1_SIS and ICF_DPA 1
Subject information and informed consent form (for publication) L1_SIS and ICF_DPA 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Genetic Addendum_FRA_Redacted 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_BEDU_redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_BEFR_Redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_ENG_redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_FRA 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_FRA_Redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_Redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main ICF_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_Redacted 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Main_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Activities Consent_BEDU_Redacted 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Activities Consent_BEFR_Redacted 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Activities Consent_ENG_Redacted 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Activity Addendum_FRA 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Activity Addendum_FRA_Redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Activity Addendum_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional activity ICF_redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Activity_PK_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Optional Genetic research 1
Subject information and informed consent form (for publication) L1_SIS and ICF_PL_Main ICF_EKBG_Redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_PL_Optional Activity ICF_EKBG_Redacted 1
Subject information and informed consent form (for publication) L1_SIS and ICF_PL_Prescreening ICF_EKBG_Unapplied 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Pre-screening ICF 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Pre-screening ICF_Redacted 1.2
Subject information and informed consent form (for publication) L1_SIS and ICF_Pre-screening ICF_redacted 1.1
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnancy Addendum_FRA_Redacted 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant participant ICF 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner Consent 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant Partner Form 1.0
Subject information and informed consent form (for publication) L1_SIS and ICF_Pregnant partner ICF 1
Subject information and informed consent form (for publication) L1_SIS and ICF_Prescreening 1
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Subject information and informed consent form (for publication) L1_SIS and ICF_Prescreening ICF 1.2
Subject information and informed consent form (for publication) L1_SIS and Prescreening ICF_BEDU 1.2
Subject information and informed consent form (for publication) L1_SIS and Prescreening ICF_BEFR 1.2
Subject information and informed consent form (for publication) L1_SIS and Prescreening ICF_ENG 1.2
Subject information and informed consent form (for publication) L1_Study Participants Pregnant Partner 1.1
Subject information and informed consent form (for publication) L1_Study Participants_Pregnant Partner 1.0
Subject information and informed consent form (for publication) L2_Compensation Information Sheet_RO 3
Subject information and informed consent form (for publication) L2_Confidentiality Company Information Notice 1
Subject information and informed consent form (for publication) L2_List of ssICF contact details_Redacted 3
Subject information and informed consent form (for publication) L2_Other subject info material_Patient Info Card 1
Subject information and informed consent form (for publication) L2_Other subject info_ MOVE LPa_Participant_Newsletter_Edition01 1
Subject information and informed consent form (for publication) L2_Other subject info_ MOVE LPa_Participant_Newsletter_Edition02 1
Subject information and informed consent form (for publication) L2_Other subject info_ MOVE LPa_Participant_Newsletter_Edition03 1
Subject information and informed consent form (for publication) L2_Other subject info_ MOVE LPa_Participant_Newsletter_Edition04 1
Subject information and informed consent form (for publication) L2_Other subject information material Emergency Card EKBG_Poland 1
Subject information and informed consent form (for publication) L2_Other subject information material Leaflet on trial subject rights 1
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Care Partner Guide_GR 1.1
Subject information and informed consent form (for publication) L2_Other subject information material_Compensation Information Sheet_Redacted 1
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Confidentiality Company Information Notice_GR 2
Subject information and informed consent form (for publication) L2_Other subject information material_Confidentiality Notice 1
Subject information and informed consent form (for publication) L2_Other Subject Information Material_ConneX Travel Contact Card_GR_Redacted 10
Subject information and informed consent form (for publication) L2_Other Subject Information Material_ConneX Travel Reference Guide for Participants_GR_Redacted 10
Subject information and informed consent form (for publication) L2_Other subject information material_e-Consent Participant-Facing Screenshots_BEDU_Redacted 1.4
Subject information and informed consent form (for publication) L2_Other subject information material_e-consent Participant-Facing Screenshots_BEFR_Redacted 1.4
Subject information and informed consent form (for publication) L2_Other subject information material_e-Consent Participant-Facing Screenshots_ENG_Redacted 1.4
Subject information and informed consent form (for publication) L2_Other Subject information material_ICF_Sponsor_Statement_ENG_Redacted 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_IQVIA eConsent Privacy Policy_BEDU 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_IQVIA eConsent Privacy Policy_BEFR 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_IQVIA eConsent Privacy Policy_ENG 1.0
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Letter Participant Welcome_GR 1.1
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Lp a Infographic_GR 2.1
Subject information and informed consent form (for publication) L2_Other subject information material_Patient Card 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_Patient card 1.0
Subject information and informed consent form (for publication) L2_Other subject information material_Patient Emergency Card 1
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Patient Newsletter_Issue 1_GR 1
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Patient Newsletter_Issue 2_GR 1
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Patient Newsletter_Issue 3_GR 1
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Patient Newsletter_Issue 4_GR 1
Subject information and informed consent form (for publication) L2_Other subject information material_Patient-facing landing page_BEDU_Redacted 1.1
Subject information and informed consent form (for publication) L2_Other subject information material_Patient-facing landing page_BEFR_Redacted 1.1
Subject information and informed consent form (for publication) L2_Other subject information material_Patient-facing landing page_ENG_Redacted 1.1
Subject information and informed consent form (for publication) L2_Other subject information material_Privacy Policy eConsent_Redacted 1
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Study Calendar 2025_GR 1.1
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Study Calendar 2026_GR 1.1
Subject information and informed consent form (for publication) L2_Other subject information material_Study Calendar 2027 1
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Study Calendar 2027_GR 1.1
Subject information and informed consent form (for publication) L2_Other subject information material_Study Calendar 2028 1
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Study Calendar 2028_GR 1.1
Subject information and informed consent form (for publication) L2_Other subject information material_Study Calendar 2029 1
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Study Calendar 2029_GR 1.1
Subject information and informed consent form (for publication) L2_Other subject information material_Study Calendar 2030 1
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Study Calendar 2030_GR 1.1
Subject information and informed consent form (for publication) L2_Other subject information material_Study Calendar Magnet 1
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Study Calendar Magnet_GR 2.1
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Study Guide Master_GR_Redacted 1.1
Subject information and informed consent form (for publication) L2_Other subject information material_Study Guide_Redacted 1
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Study Medicine Reminder Card_GR_Redacted 2.1
Subject information and informed consent form (for publication) L2_Other subject information material_Study Medicine Reminder Card_Redacted 1
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Study Medicine Reminder Magnet_GR_Redacted 2.1
Subject information and informed consent form (for publication) L2_Other subject information material_Study Medicine Reminder Magnet_redacted 1
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Thank You End Of Study_Master_GR 1.1
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Thank You Participation_GR 1.1
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Thank You Screening_GR 1.1
Subject information and informed consent form (for publication) L2_Other subject information material_Visit Card 1
Subject information and informed consent form (for publication) L2_Other Subject Information Material_Visit Card Noname_Master_GR 2.1
Subject information and informed consent form (for publication) L2_Other Subject Information_Patient Card 1.0
Subject information and informed consent form (for publication) L2_Study Participant Contact Card_GR 1
Subject information and informed consent form (for publication) L2_Study Participant Contact Card_Romania 1
Subject information and informed consent form (for publication) L2_Subject information material_eConsent Submission Letter_Eli Lilly - J2O-MC-EKBG_Italy 4.0
Subject information and informed consent form (for publication) L2_Subject information material_IQVIA Complete Consent Security and Privacy Quick Reference Guide 1.5
Subject information and informed consent form (for publication) L2_Subject information material_IQVIA E2E Privacy Policy 1.0
Subject information and informed consent form (for publication) L2_Subject information material_IQVIA Getting Started Patient-facing landing page 1.1
Subject information and informed consent form (for publication) L2_Subject information material_Notification Letter IQVIA complete consent platform update 1
Subject information and informed consent form (for publication) L2-Subject information material_IQVIA Complete Consent - Participant-Facing Screenshots 1.4
Subject information and informed consent form (for publication) L3_Other subject information material_ Study-Medicine-Reminder-Card_Redacted 2
Subject information and informed consent form (for publication) L3_Other subject information material_Brochure_Redacted 1
Subject information and informed consent form (for publication) L3_Other subject information material_Flyer 1
Subject information and informed consent form (for publication) L3_Other subject information material_Letter-Doctor-to-Patient_Redacted 1
Subject information and informed consent form (for publication) L3_Other subject information material_Lp a -Infographic 2
Subject information and informed consent form (for publication) L3_Other subject information material_Poster 1
Subject information and informed consent form (for publication) L3_Other subject information material_Study-Calendar-2025 1
Subject information and informed consent form (for publication) L3_Other subject information material_Study-Calendar-2026 1
Subject information and informed consent form (for publication) L3_Other subject information material_Study-Calendar-2027 1
Subject information and informed consent form (for publication) L3_Other subject information material_Study-Calendar-2028 1
Subject information and informed consent form (for publication) L3_Other subject information material_Study-Calendar-2029 1
Subject information and informed consent form (for publication) L3_Other subject information material_Study-Calendar-2030 1
Subject information and informed consent form (for publication) L3_Other subject information material_Study-Calendar-Magnet 2
Subject information and informed consent form (for publication) L3_Other subject information material_Study-Guide_Redacted 1
Subject information and informed consent form (for publication) L3_Other subject information material_Study-Medicine-Reminder-Magnet_Redacted 2
Subject information and informed consent form (for publication) L3_Other subject information material_Visit-Card-Noname 2
Subject information and informed consent form (for publication) L3_Patient card_master 1
Subject information and informed consent form (for publication) L3_patient contact card 2
Subject information and informed consent form (for publication) L4_Compensation Information Sheet_EKBG_PL 1.0
Subject information and informed consent form (for publication) L5_Info Re insurance Conditions for Patient 1.0
Synopsis of the protocol (for publication) D1_Protocol Synopsis _NL_2025-521067-13-00_Redacted 2.0
Synopsis of the protocol (for publication) D1_Protocol Synopsis 2025-521067-13-00 IT _Redacted a
Synopsis of the protocol (for publication) D1_Protocol Synopsis EN 2025-521067-13-00_ro-ROM_Redacted a
Synopsis of the protocol (for publication) D1_Protocol Synopsis_2025-521067-13-00_GR_Redacted a
Synopsis of the protocol (for publication) D1_Protocol Synopsis_2025-521067-13-00_PL_Redacted a
Synopsis of the protocol (for publication) D1_Protocol synopsis_AT_2025-521067-13-00_Redacted a
Synopsis of the protocol (for publication) D1_Protocol Synopsis_BEDU_2025-521067-13-00_Redacted a
Synopsis of the protocol (for publication) D1_Protocol Synopsis_BEFR_2025-521067-13-00_Redacted a
Synopsis of the protocol (for publication) D1_Protocol Synopsis_BEGE_2025-521067-13-00_Redacted a
Synopsis of the protocol (for publication) D1_Protocol Synopsis_CZ_2025-521067-13-00_Redacted a
Synopsis of the protocol (for publication) D1_Protocol Synopsis_ENG_2025-521067-13-00_Redacted a
Synopsis of the protocol (for publication) D1_Protocol synopsis_ES_2025-521067-13-00_Redacted a
Synopsis of the protocol (for publication) D1_Protocol Synopsis_FRA_2025-521067-13-00_Redacted a
Synopsis of the protocol (for publication) D1_Protocol Synopsis_HU_2025-521067-13-00_redacted a
Synopsis of the protocol (for publication) D1_Protocol Synopsis_SK_Redacted a

Application history

19 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-06-20 Germany Acceptable
2025-10-13
 2025-10-13
2 NON SUBSTANTIAL MODIFICATION NSM-1 2025-10-21 Acceptable
2025-10-13
 2025-10-21
3 SUBSTANTIAL MODIFICATION SM-1 2025-10-22 Acceptable 2025-10-23
4 SUBSTANTIAL MODIFICATION SM-2 2025-10-24 Acceptable 2025-11-24
5 SUBSTANTIAL MODIFICATION SM-4 2025-11-12 Acceptable 2026-01-29
6 SUBSTANTIAL MODIFICATION SM-3 2025-11-14 Germany Acceptable 2026-02-04
7 SUBSTANTIAL MODIFICATION SM-7 2026-01-30 Acceptable 2026-03-16
8 SUBSTANTIAL MODIFICATION SM-8 2026-02-06 Acceptable 2026-02-20
9 SUBSTANTIAL MODIFICATION SM-5 2026-02-11 Acceptable 2026-03-23
10 SUBSTANTIAL MODIFICATION SM-9 2026-02-11 Germany Acceptable 2026-04-02
11 SUBSTANTIAL MODIFICATION SM-6 2026-02-19 Acceptable 2026-04-16
12 SUBSTANTIAL MODIFICATION SM-10 2026-02-24 Acceptable 2026-02-26
13 SUBSTANTIAL MODIFICATION SM-12 2026-02-24 Acceptable 2026-03-06
14 SUBSTANTIAL MODIFICATION SM-11 2026-02-27 Acceptable 2026-03-23
15 SUBSTANTIAL MODIFICATION SM-14 2026-03-25 Acceptable 2026-05-08
16 SUBSTANTIAL MODIFICATION SM-15 2026-03-26 Acceptable 2026-04-07
17 SUBSTANTIAL MODIFICATION SM-13 2026-03-31 Acceptable 2026-05-08
18 SUBSTANTIAL MODIFICATION SM-17 2026-04-27 Germany Acceptable 2026-06-03
19 SUBSTANTIAL MODIFICATION SM-16 2026-05-06 Acceptable 2026-06-01

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