A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

2025-523123-22-00 Protocol J2A-MC-GZPW Therapeutic confirmatory (Phase III) Ongoing, recruiting

Start 7 May 2026 · Status Ongoing, recruiting · 17 EU/EEA countries · 209 sites · Protocol J2A-MC-GZPW

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Ongoing, recruiting

Participants planned 7,140

Countries 17

Sites 209

Chronic Kidney Disease

To demonstrate whether orforglipron is superior to placebo in reducing the risk for major CV events.

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: 7 May 2026 → ongoing
Decision date (initial): 2026-03-01
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2025-523123-22-00
WHO UTN: U1111-1326-0582

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

To demonstrate whether orforglipron is superior to placebo in reducing the risk for major CV events.

Conditions and MedDRA coding

Chronic Kidney Disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

Have heart disease, kidney disease, or both

Exclusion criteria 3

Have type 1 diabetes
Have had a serious heart condition within 60 days of screening
Have New York Heart Association Functional Classification Class IV heart failure

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events Composite endpoint includes nonfatal myocardial infarction, nonfatal stroke, hospitalization or urgent visit due to heart failure, coronary revascularization, or all-cause death [Time Frame: Baseline up to end of study (about 5 years)]

Investigational products

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

Test 6

PRD12263027 · Product

Active substance: Orforglipron Hemicalcium
Substance synonyms: Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 0 mg milligram(s)
Max total dose: 0 mg milligram(s)
Max treatment duration: 60 Month(s)
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY LIMITED
Paediatric formulation: No
Orphan designation: No

PRD12263031 · Product

Active substance: Orforglipron Hemicalcium
Substance synonyms: Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 0 mg milligram(s)
Max total dose: 0 mg milligram(s)
Max treatment duration: 60 Month(s)
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY LIMITED
Paediatric formulation: No
Orphan designation: No

PRD12263032 · Product

Active substance: Orforglipron Hemicalcium
Substance synonyms: Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 0 mg milligram(s)
Max total dose: 0 mg milligram(s)
Max treatment duration: 60 Month(s)
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY LIMITED
Paediatric formulation: No
Orphan designation: No

PRD12263029 · Product

Active substance: Orforglipron Hemicalcium
Substance synonyms: Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 0 mg milligram(s)
Max total dose: 0 mg milligram(s)
Max treatment duration: 60 Month(s)
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY LIMITED
Paediatric formulation: No
Orphan designation: No

PRD12263028 · Product

Active substance: Orforglipron Hemicalcium
Substance synonyms: Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 0 mg milligram(s)
Max total dose: 0 mg milligram(s)
Max treatment duration: 60 Month(s)
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY LIMITED
Paediatric formulation: No
Orphan designation: No

PRD12263030 · Product

Active substance: Orforglipron Hemicalcium
Substance synonyms: Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
Pharmaceutical form: TABLET
Route of administration: ORAL
Max daily dose: 0 mg milligram(s)
Max total dose: 0 mg milligram(s)
Max treatment duration: 60 Month(s)
Authorisation status: Not Authorised
MA holder: ELI LILLY AND COMPANY LIMITED
Paediatric formulation: No
Orphan designation: No

Placebo 1

Placebo to match

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.

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 9

Organisation	City, country	Duties
Pharmaceutical Product Development LLC ORG-100016999	Highland Heights, United States	Laboratory analysis
Trialbee AB ORG-100051369	Malmo, Sweden	Other
Pharmaserve Lilly S.A.C.I. ORG-100005347	Kifisia, Greece	On site monitoring, Code 12, Other, Code 2, Code 5
Clariness GmbH ORG-100045306	Hamburg, Germany	Other
Pharmaceutical Product Development, LLC ORL-000015921	Shanghai, China	Laboratory analysis
PPD Global Central Labs ORG-100046496	Zaventem, Belgium	Laboratory analysis
PPD Global Central Labs (S) Pte Ltd ORG-100041754	Singapore, Singapore	Laboratory analysis
Iqvia Biotech LLC ORG-100008704	Durham, United States	On site monitoring
Veeva Systems Inc. ORG-100006053	Pleasanton, United States	Data management

Locations

17 EU/EEA countries · 209 investigational sites

By country

Country	MS status	Planned subjects	Sites
Austria	Ongoing, recruiting	43	8
Belgium	Ongoing, recruiting	118	14
Bulgaria	Authorised, recruitment pending	96	10
Czechia	Ongoing, recruiting	194	14
Estonia	Authorised, recruitment pending	78	4
France	Ongoing, recruiting	61	14
Germany	Ongoing, recruiting	67	8
Greece	Ongoing, recruiting	67	8
Hungary	Ongoing, recruiting	121	15
Italy	Ongoing, recruiting	90	15
Lithuania	Authorised, recruiting	85	7
Netherlands	Authorised, recruitment pending	148	23
Poland	Ongoing, recruiting	211	21
Romania	Authorised, recruitment pending	182	20
Slovakia	Ongoing, recruiting	84	11
Spain	Ongoing, recruiting	148	16
United States		0	1
Rest of world Serbia, Colombia, South Africa, Japan, China, Thailand, Israel, Taiwan, Mexico, Brazil, Korea, Republic of, India, Australia, Tunisia, United Kingdom, Malaysia, Turkey, New Zealand, Canada, Argentina, Ukraine, Philippines	—	5,347	—

Investigational sites

8 sites · Ongoing, recruiting

Vivit

N/A, Carinagasse 47, 6800, Feldkirch

Dr. Distelmaier & Dr. Goliasch Gruppenpraxis Fuer Innere Medizin Und Kardiologie OG

N/A, Theresiengasse 43/7, 1180, Vienna

Ordensklinikum Linz GmbH

Abteilung für Innere Medizin 2 - Kardiologie, Angiologie und Intensivmedizin,, Fadingerstrasse 1, 4020, Linz

Ordination Dr. Evelyn Fliesser-Görzer

N/A, Kastaniensiedlung 1, 8511, St. Stefan ob Stainz

Klinik Floridsdorf

Abteilung für Kardiologie, Brünner Straße 68, 1210, Wien

Klinik Hietzing

Medizinische Abteilung mit Stoffwechselerkrankungen und Nephrologie, Wolkersbergenstrasse 1, Hietzing, Vienna

Medizinische Universität Graz

Forschungseinheit Interdisziplinäre Metabolische Medizin, Auenbruggerplatz 15, Graz, Graz

Cardio Metabolic Centre

N/A, Hauptplatz 3/1/1.10, 7210, Mattersburg

14 sites · Ongoing, recruiting

CHU Tivoli

Endocrinology, Avenue Max Buset 34, 7100, Louvière

Algemeen Ziekenhuis Damiaan Oostende

Endocrinology, Gouwelozestraat 100, 8400, Ostend

Ziekenhuis Oost Limburg

Nefrologie, Synaps Park 1, 3600, Genk

Algemeen Ziekenhuis Delta

Nephrology, Deltalaan 1, 8800, Roeselare

UZ Leuven

Endocrinology, Herestraat 49, 3000, Leuven

AZ Sint-Maarten

cardiology, 435 Liersesteenweg, 2800, Mechelen

Imelda General Hospital

Associatie Dialyse Endocrinologie, Wolzakken 22, 2580, Putte

Algemeen Ziekenhuis Groeninge

Endocrinology, President Kennedylaan 4, 8500, Kortrijk

Algemeen Ziekenhuis Klina

Cardiologie, Augustijnslei 100, 2930, Brasschaat

Jan Yperman Ziekenhuis

Endocrinologie-Diabetologie, Briekestraat 12, 8900, Ieper

Jessa Ziekenhuis

Cardiology, Stadsomvaart 11, 3500, Hasselt

Kormont

Kormont, Kwaremontplein 45, 9690, Kluisbergen

Cliniques Universitaires Saint-Luc

Nephrology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe

UZ Leuven

Nephrology, Herestraat 49, 3000, Leuven

10 sites · Authorised, recruitment pending

University Multiprofile Hospital For Active Treatment Saint Georgi EAD

Clinic of Endocrinology and Metabolic Diseases, Bulevard Vasil Aprilov 15a, 4002, Plovdiv

Medical Center New Polyclinic Gabrovo Ltd.

Cardiology Cabinet, Bulevard Mogilyov 52a, 5312, Gabrovo

Medical Center Rusemed EOOD

Endocrinology, Floor 5, Bulevard Lipnik 123, Ruse

Diagnostic-Consultative Center Alexandrovska EOOD

NA, Triaditsa, Ulitsa Sveti Georgi Sofiyski 1, Sofiya

University Multiprofile Hospital For Active Treatment Kaspela EOOD

Clinic of Endocrinology and Metabolic Diseases, Zapaden District, Sofia Str 64, Plovdiv

University Multiprofile Hospital For Active Treatment Pulmed Ltd.

Clinic of Internal Diseases - Endocrinology and Metabolic Diseases, Ulitsa Perushtitsa 1a, 4002, Plovdiv

Alexandrovska University Hospital

Clinic of Cardiology, Georgy Sofiiski Str 1, 1431, Sofia

Tonus 2013 Ltd.

NA, Bulevard Tsar Osvoboditel 41, 4400, Pazardzhik

University Multiprofile Hospital For Active Treatment Saint Georgi EAD

lnterventional Cardiology Department, Bulevard Peshtersko Shose 66, 4002, Plovdiv

Medical Center Berbatov Ltd.

Medicine, Ulitsa Beli Drin 9, 8600, Yambol

14 sites · Ongoing, recruiting

MUDr. Alena Váchová Diabetologie a obezitologie

N/A, České Vrbné 2403, 370 11, České Budějovice

Milan Kvapil s.r.o.

N/A, Michnova 1622/4, Chodov, Prague

Centrum kardiovaskularni mediciny s.r.o.

N/A, Pod Marjankou 1906/12, Brevnov, Prague

Diavital Jesenice s.r.o.

N/A, Rudnych Dolu 291, 254 01, Jilove U Prahy

DIKa centrum s.r.o.

N/A, Karvinska 1518/5, Mesto, Havirov

Praglandia s.r.o.

N/A, Nadrazni 3368/30a, Smichov, Prague

KardioInt s.r.o. Lékařský dům Géčko

N/A, České Vrbné 2403, 370 11, České Budějovice

MUDr. Jana Parkanyiová Endokrinologie a diabetologie

N/A, Revoluční 765/19, 110 00, Praha 1

MUDr. Tomas Edelsberger Diabetologie

N/A, Náměstí Minoritů 86/7, 794 01, Krnov

Diabetologie a endokrinologie, J.Venerová s.r.o.

NA, Pod Marjánkou 1906/12, 169 00, Praha 6

Kardiologie KarMa s.r.o.

NA, Jablonec nad Nisou 2315/11, 466 01, Poštovní

DIACENTRUM Brandys n.L. s.r.o.

N/A, Jiriho Wolkera 603/1, 250 01, Brandys Nad Labem

Kardio Chlumec s.r.o.

N/A, Nadrazni 783, 503 51, Chlumec Nad Cidlinou Iv

MUDr. Miroslav Koliba s.r.o.

N/A, Kubalova 388/47, Vyskovice, Ostrava

4 sites · Authorised, recruitment pending

Estendo Private Clinic

NA, Adala Street 1, Floor 3, Tallinn

North Estonia Medical Centre Foundation

Centre of cardiology, J. Sutiste Tee 19, Mustamae Linnaosa, Tallinn

Center for Clinical and Basic Research AS

Research Facility, J. Parna Tn 4, Kesklinna Linnaosa, Tallinn

Liina Viitas OÜ

Endocrinology, Veetorni 2-1, 80018, Paernu

14 sites · Ongoing, recruiting

Hospital Edouard Herriot

Nephrology, 5 Place D Arsonval, 69003, Lyon

Les Hopitaux Universitaires De Strasbourg

Endocrinologie Diabétologie et Nutrition, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2

Centre Hospitalier Regional Universitaire De Tours

Nephrology, 2 Boulevard Tonnelle, 37044, Tours Cedex 9

Centre Hospitalier Louis Pasteur

cardiologie - diabétologie - néphrologie, 4 rue Claude Bernard, Le Coudray, Le Coudray

Centre Hospitalier Universitaire de Nice - Hopital Pasteur

Service cardiologie, 30 av de la Voie Romaine, Nice Cedex 1, Nice

Centre Hospitalier Universitaire De Toulouse

Diabétologie, maladies métaboliques et nutrition, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9

Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes

CIC Endocrinology-Diabetology-Nutrition, Boulevard Professeur Jacques Monod, Saint Herblain, Saint-Herblain

Hopitaux Universitaires Pitie Salpetriere

Institut de Cardiologie, 47 To 83 Boulevard De L Hopital, 75013, Paris

CHRU De Nancy

Nephrology, Rue Du Morvan, 54500, Vandoeuvre Les Nancy

Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace

Nephrology, 20 Avenue Du Docteur Rene Laennec, 68100, Mulhouse

Centre Hospitalier Universitaire Rouen

Nephrology, 147 Avenue Du Marechal Juin, 76230, Bois-Guillaume

CHU Gabriel-Montpied

Nephrologie, 58 Rue Montalembert, 63000, Clermont Ferrand

Chu Grenoble Alpes

N/A, Boulevard de la Chantourne, La Tronche, La Tronche

Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

Nephrology, 1 place Alexis-Ricordeau, Nantes, Nantes

8 sites · Ongoing, recruiting

Die Bocholder Hausärzte

N/A, Bocholderstr. 158, 45355, Essen, Ruhr

Studienzentrum Brinkum

N/A, Melcherstätte 7, 28816, Stuhr

medicoKIT GmbH

N/A, Brueckenstrasse 42, 47574, Goch

R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH

N/A, Markt 15, 23758, Oldenburg In Holstein

Zentrum fur klinische Forschung - Köln

N/A, Berliner Strasse 895, 1. OG, Köln

Diabeteszentrum Hamburg West

N/A, Beselerstrasse 2a, 22607, Hamburg

Medizentrum Essen Borbeck

N/A, Huelsmannstrasse 6, Borbeck, Essen

Klinisches Forschungszentrum Dr. Hagemann am Hausarztzentrum am Germaniaplatz

N/A, Germaniaplatz 8, 45355, Essen

8 sites · Ongoing, recruiting

University General Hospital Of Thessaloniki Ahepa

1st Cardiology Clinic, 1st St Kiriakidis Str, 546 36, Thessaloniki

Athens Medical Center S.A.

Diabetes Department, Areos 36, 175 62, Paleo Faliro

Athens Medical Center S.A.

Department of Internal Medicine, Pylea, Asklipiou 10, Thessaloniki

Hippokration Hospital

Diabetes Center, 2nd Propaedeutic Internal Medicine Clinic, Konstadinoupoleos 49, 546 42, Thessaloniki

General Hospital Of Athens Alexandra

Department of Clinical Therapeutics, Vassilissis Sofias Avenue 80, 115 28, Athens

Athens Medical Center S.A.

Internal Medicine Clinic and Metabolic Diseases, Adersen 1, 115 25, Athens

Athens Medical Center S.A.

Department of Internal Medicine, Diabetes and Obesity Unit, Distomou 5-7, 151 25, Maroussi

University General Hospital Of Ioannina

2nd Department of Internal Medicine, Niarchou Stavrou Avenue, 455 00, Ioannina

15 sites · Ongoing, recruiting

Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz

Klinikai Kutatasi Osztaly, Szent Istvan Utca 68, 4400, Nyiregyhaza

KomplexLabor Kft.

N/A, Izsaki Ut 8 D Ep, 6000, Kecskemet

DRC Kft.

N/A, Ady Endre Utca 12/b, 8230, Balatonfured

Kistarcsai Flor Ferenc Korhaz

V. Belgyogyászat, Semmelweis Ter 1, 2143, Kistarcsa

Regia Med Kft.

N/A, Bregyo Koz 5, 8000, Szekesfehervar

Szent Margit Rendelointezet Nonprofit Kft.

Diabetologiai Szakrendelo, Vorosvari Ut 88-96/III, III Kerulet, Budapest III

CRU Hungary Kft.

N/A, Petofi Ut 26a, 3860, Encs

University Of Szeged

Szent-Gyorgyi Albert KK, Belgyogyaszati Klinika,Nyugati telephely, Kalvaria Sugarut 57, 6725, Szeged

Central Hospital Of Northern Pest Military Hospital

Diabetologia Szakrendelo, Robert Karoly Korut 44, 1134, Budapest XIII

Ujpesti Egeszsegkoezpont

Endokrinologia, Diabetologia, Gorgey Artur Ut 30, 1046, Budapest IV

ClinDiab Kft.

N/A, Benyovszky Moric Utca 10/VIII, VIII Kerulet, Budapest VIII

University Of Debrecen

Klinikai Kozpont Belgyogyaszati Intezet, Nagyerdei Korut 98, 4032, Debrecen

Cardiogeneral Kft.

N/A, Bonyhadi Ut 127, 1141, Budapest XIV

Zala Varmegyei Szent Rafael Korhaz

Diabetologia, Zrinyi Miklos Utca 1, 8900, Zalaegerszeg

PVN Kutato Kft.

N/A, Halom Utca 10, 1102, Budapest X

15 sites · Ongoing, recruiting

IRCCS Ospedale Policlinico San Martino

Clinica Nefrologica, Dialisi e Trapianto, Largo Rosanna Benzi 10, 16132, Genoa

Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

Nephrology Unit, Piazzale Spedali Civili 1, 25123, Brescia

Policlinico San Donato S.p.A.

Endocrinologia, Piazza Edmondo Malan 2, 20097, San Donato Milanese

Azienda Ospedaliero Universitaria S.Anna

Centro dello Scompenso, Via Aldo Moro 8, 44100, Ferrara

Istituto Clinico Humanitas

Nephrology and Dialysis, Via Manzoni 56, 20089, Rozzano

Azienda Ospedaliero Universitaria Parma

UO Cardiologia, Viale Antonio Gramsci 14, 43126, Parma

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Dipartimento ProMISE, Via Del Vespro 129, 90127, Palermo

Hospital Santa Maria Della Misericordia

Department of Medicine and Surgery, Piazzale Giorgio Menghini 1, 06129, Perugia

Ospedale San Raffaele S.r.l.

Unità Cardio-Metabolica e Trials Clinici Loc. 1, Via Olgettina 60, 20132, Milan

Policlinico Di Monza S.p.A.

Dipartimento Medicina Interna e Riabilitazione - Medicina Metabolica, Via Carlo Amati 111, 20900, Monza

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

UOC NEFROLOGIA, Largo Francesco Vito 1, 00168, Rome

Azienda Ospedaliero Universitaria Careggi

SOD MALATTIE ATEROTROMBOTICHE, Largo Giovanni Alessandro Brambilla 3, 50134, Florence

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Dipartimento Scienze Mediche e Chirurgiche -Obesità, Largo Francesco Vito 1, 00168, Rome

AOU Bologna Policlinico di Sant’Orsola

UO Nefrologia, Dialisi e Trapianto, Via Massarenti, 9, Bologna

Centro Cardiologico Monzino S.p.A.

Diabetology, Via Carlo Parea 4, 20138, Milan

7 sites · Authorised, recruiting

Klinikiniai Sprendimai UAB

NA, Vilties G. 4-46, Alytaus M. Sav., Alytus

Vilniaus Universiteto Ligonine Santaros Klinikos Vsi

Nephrology Center, Santariskiu G 2, Vilniaus M. Sav., Vilnius

Inmedica UAB

NA, Petro Baublio G. 2, Vilniaus M. Sav., Vilnius

Saules seimos medicinos centras UAB

NA, Partizanu G. 27d, Kauno M. Sav., Kaunas

Kristavita UAB

NA, P. Vaiciuno G. 15-2, Jonavos R. Sav., Jonava

Hormodernus UAB

NA, Tolminkiemio G. 1a, Kauno M. Sav., Kaunas

Klinikiniai Sprendimai UAB

NA, P. Luksio G. 3, Kauno M. Sav., Kovno

23 sites · Authorised, recruitment pending

Stichting Viecuri Medisch Centrum voor Noord-Limburg

Cardiology, Tegelseweg 210, 5912 BL, Venlo

Academisch Medisch Centrum

Vascular Medicine Clin Trial Unit, Meibergdreef 9, 1105 AZ, Amsterdam

Stichting OLVG

Cardiology, Oosterpark 9, 1091 AC, Amsterdam

Groene Hart Ziekenhuis

Research Cardiology, Bleulandweg 10, 2803 HH, Gouda

Diakonessenhuis Stichting

Research Cardiologie, Bosboomstraat 1, 3582 KE, Utrecht

Alrijne Zorggroep Stichting

Cardiology, Simon Smitweg 1, 2353 GA, Leiderdorp

Jeroen Bosch Ziekenhuis Stichting

Research Cardiology, Henri Dunantstraat 1, 5223 GZ, 'S-Hertogenbosch

Universitair Medisch Centrum Utrecht

Vasculaire Geneeskunde, Heidelberglaan 100, 3584 CX, Utrecht

Bravis Ziekenhuis

Cardiology, Boerhaavelaan 25, 4708 AE, Roosendaal

EB FlevoResearch B.V.

NA, Louis Armstrongweg 88, 1311 RL, Almere

Slingeland Ziekenhuis

Cardiology, Kruisbergseweg 25, 7009 BL, Doetinchem

Radboud universitair medisch centrum Stichting

Interne Geneeskunde, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen

Stichting Martini Ziekenhuis

Cardio Research Noord, Van Swietenplein 1, 9728 NT, Groningen

Albert Schweitzer Ziekenhuis

Interne Geneeskunde, Albert Schweitzerplaats 25, 3318 AT, Dordrecht

Meander Medisch Centrum

Interne Geneeskunde, Maatweg 3, 3813 TZ, Amersfoort

Frisius MC

Cardiology, Henri Dunantweg 2, 8934 AD, Leeuwarden

Rijnstate Ziekenhuis Stichting

Vasculair geneeskunde, Wagnerlaan 55, 6815 AD, Arnhem

Gelre Hospitals

Interne Geneeskunde, Albert Schweitzerlaan 31, 7334 DZ, Apeldoorn

Sint Franciscus Vlietland Groep Stichting

Cardiology, Vlietlandplein 2, 3118 JH, Schiedam

Maxima Medisch Centrum

Cardiology, De Run 4600, 5504 DB, Veldhoven

Catharina Ziekenhuis Stichting

Cardiology, Michelangelolaan 2, 5623 EJ, Eindhoven

Het Van Weel-Bethesda Ziekenhuis

Cardiology, Stationsweg 22, 3247 BW, Dirksland

Frisius MC

Cardiology, Thialfweg 44, 8441 PW, Heerenveen

21 sites · Ongoing, recruiting

In Vivo Sp. z o.o.

N/A, Ul. Kaszubska 17h, 85-048, Bydgoszcz

Poradnia Aka-Med Centrum Sp. z o.o.

NA, Ul. 1 Maja 323, 41-710, Ruda Slaska

Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.

NA, Ul. Rusznikarska 17, 31-261, Cracow

Miedzyleski Szpital Specjalistyczny W Warszawie

Oddzial Nefrologii i Stacja Dializ, Ul. Bursztynowa 2, 04-749, Warsaw

Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A Wittek H Rudzki Sp. j.

NA, Ul. Piotra Niedurnego 50 D, 41-709, Ruda Slaska

Medon Clinical Research Sp. z o.o.

NA, Ul. Zygmunta Modzelewskiego 6, 02-679, Warsaw

Centrum Szybkiej Diagnostyki Kardiologicznej Kardiomed M. Zabowka E. Zabowka

N/A, ul. Lwowska 197, 33-100, Tarnów

Ambulatorium Sp. z o.o.

NA, Ul. Topolowa 28, 82-300, Elblag

Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.

NA, Ul. Przedzalniana 66, 90-338, Lodz

Samodzielny Publiczny Zespol Zakladow Opieki Zdrowotnej W Wyszkowie

NA, Ul. Komisji Edukacji Narodowej 1, 07-200, Wyszkow

Clinical Best Solutions Sp. z o.o. S.K.

NA, Aleja Jozefa Pilsudskiego 11, 20-011, Lublin

Kardio Life

N/A, Warszawska 15/17, 87-800, Włocławek

Zdrowie Osteo-Medic

N/A, ul.Wiejska 81, 15-351, Białystok

ETG Lublin Sp. z o.o.

NA, Ul. Czarnieckiego 5, 39-200, Debica

Specderm Poznanska Sp. j.

NA, Ul. Prezydenta Ryszarda Kaczorowskiego 7/u 50, 15-375, Bialystok

Centrum Medyczne Neuromed Sp. z o.o.

NA, Ul. Jana Biziela 14, 85-163, Bydgoszcz

Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.

NA, Ul. Krolowej Jadwigi 16, 85-231, Bydgoszcz

Centrum Wsparcia Badań Klinicznych 4 Wojskowego Szpitala Klinicznego we Wrocławiu

N/A, Rudolfa Weigla 5, 50-981, Wrocław

Prywatny Gabinet Lekarski Centrum Medyczne Diabetika

N/A, ul. Focha 12/4, 26-600, Radom

Uniwersytecki Szpital Kliniczny W Bialymstoku

NA, Ul. Marii Curie-Sklodowskiej 24a, 15-276, Bialystok

Velocity Skierniewice Sp. z o.o.

NA, Ul. Ogrodowa 21/23, 96-100, Skierniewice

20 sites · Authorised, recruitment pending

Nicodiab S.R.L.

Diabetes, Nutrition and Metabolic Diseases, Strada Polona Nr 92, 010507, Bucharest

Mediab S.R.L.

Diabetes, Nutrition and Metabolic Diseases, Apartament I-II, Strada Marinescu Gheorghe Nr 8a, Targu Mures

Spitalul Clinic De Urgenta Prof Dr Agrippa Ionescu

Cardiology, 149th Ic Bratianu Street, 077015, Balotesti

Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop Lavinia

Diabetes-Nutrition-Metabolic Disorders, Strada George Cosbuc no. 25A / 2, Baia Mare,, Maramureș

Cmi Cardiologie-Dr. Mercea Corina Delia

Cardiology, str. Petre Dulfu nr 12A, Spatiu Comercial nr.1, Baia Mare

Clinica Korall S.R.L.

Diabetes, Nutrition and Metabolic Diseases, Piata Eroilor Revolutiei, Corp A Apartament M 2 Nr 22, Satu Mare

Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.

Diabetes, Nutrition and Metabolic Diseases, Block 1 Staircase C Apartment 2 Room 2, Strada Crisului Nr 1, Brasov

Diabdana S.R.L.

Diabetes, Nutrition and Metabolic Diseases, Calea Republicii Nr 77, 410147, Oradea

CMI Dr. Podoleanu Cristian

Cardiology, Aleea Cornisa, Nr. 5, Targu-Mures

CRN Clinical Research Network S.R.L.

Cardiology, Bulevardul Pallady Theodor Nr. 47, 032258, Bucharest

Dianutrilife Medica S.R.L.

Diabetes, Nutrition and Metabolic disease, Strada Glinca Alexandru Nr. 37, 100561, Ploiesti

Diabet Med S.R.L.

Diabetes, Nutrition and Metabolic Diseases, Calea Rahovei No 322d, 050913, Bucharest

Lotus Med S.R.L.

Nefrology, Strada Tunari No. 44 Sector 2, 020528, Bucharest

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

Medicali's S.R.L.

Cardiology, Strada Cernauti 13, 300362, Timisoara

Easydiet S.R.L.

Diabetes, Nutrition and Metabolic Diseases, Strada Alexandrescu Grigore Nr 80 Sector 1, 010627, Bucharest

Nutrilife S.R.L.

Diabetes, Nutrition and Metabolic Diseases, Strada Dobrogeanu-Gherea Constantin 10-12, 013764, Bucharest

Cabinet Medical Dr Geru S.R.L.

Diabetes, Nutrition and Metabolic Diseases, Aleea Lirei Nr 1, Ap. 2, Timisoara

Cardiomed S.R.L.

Diabetes-Nutrition-Metabolic Disorders, Aleea Neculai Tudor C1, 700732, Iași

11 sites · Ongoing, recruiting

B. Braun Avitum s.r.o.

N/A, Hodska 2378/85, 924 01, Galanta

Medispektrum s.r.o.

Ambulancia diabetologie a poruch latkovej premeny a vyzivy, Gercenova 4/a, 851 01, Petrzalka

MUDr. Zakova s.r.o.

NA, Suvoz 1, Kubra, Trencin

DIA MED CENTRUM s.r.o.

N/A, Tajovskeho 8568/3, 010 01, Zilina

Diacrin s.r.o.

N/A, Jelsova 3086/1, Nove Mesto, Bratislava

B. Braun Avitum s.r.o.

N/A, Mieru 1887/30, 028 01, Trstena

B. Braun Avitum s.r.o.

N/A, M. R. Stefanika 10, 902 01, Pezinok

Medivasa s.r.o.

Diabetologicka ambulancia, Vojtecha Spanyola 8187, 010 01, Zilina

Spaolo s.r.o.

N/A, Mytna 5/146, 916 01, Stara Tura

Dentavia s.r.o.

N/A, Levocska 5112 26b, 058 01, Poprad

Intern s.r.o.

Ambulancia vnutorneho lekarstva, Štúrova 846/39, 019 01, Ilava

16 sites · Ongoing, recruiting

Hospital Universitario Puerta De Hierro De Majadahonda

Nefrology, Calle De Manuel De Falla 1, 28222, Majadahonda

Hospital Universitario Dr Peset Aleixandre

Endocrinology, Avinguda De Gaspar Aguilar 90, 46017, Valencia

Hospital Universitario De La Ribera

Endocrinology, Carretera Corbera Km 1, 46600, Alzira

Hospital Universitari Vall D Hebron

Endocrinology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona

Centro Periférico de Especialidades Bola Azul

Endocrinology, Ctra. de Ronda nº 226 04008 Almería, 04008, Andalucia

University Hospital Virgen Del Rocio S.L.

Endocrinology, Avenida De Manuel Siurot S/n, 41013, Sevilla

Hospital Polusa S.A.

Nefrology, Calle Del Doctor Iglesias Otero S/N, San Lazaro Del Puente, Lugo

Hospital Clínico de Valencia

Nefrology, Carrer del Dr. Gómez Ferrer, 2, Valencia

Hospital Universitario De Badajoz

Nefrology, Avenida Elvas S/n, 06006, Badajoz

Hospital Quironsalud Infanta Luisa

Endocrinology and metabolism, Calle De San Jacinto 87, 41010, Sevilla

Hospital Germans Trias I Pujol

Endocrinology, Carretera Canyet 1a Planta, 08916, Badalona

Hospital Universitario Hm Monteprincipe

Cardiology, Avenida De Monteprincipe 25, 28660, Boadilla Del Monte

Hospital Clinico Universitario De Valladolid

Endocrinology, Avenida Ramon Y Cajal 3, 47003, Valladolid

Hospital Alta Resolución De Utrera

cardiology, Avda. Brigadas Internacionales, s/n planta 0 bloque 3, Utrera Andalucia

Hospital Universitario Marques De Valdecilla

Endocrinology and Matabolism, Avenida Valdecilla Sn, 39008, Santander

University Hospital Son Espases

Endocrinology, Carretera Valldemossa 79, 07120, Palma

1 site ·

Centre Hospitalier Régional de la Citadelle

Cardiology, Boulevard du 12ème de Ligne 1, 4000, Liège

Country notifications

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

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Austria	2026-05-11		2026-05-13
Belgium	2026-05-13		2026-05-21
Czechia	2026-05-15		2026-05-19
France	2026-05-14		2026-05-19
Germany	2026-05-11		2026-05-19
Greece	2026-05-07		2026-05-08
Hungary	2026-05-18		2026-05-20
Italy	2026-05-12		2026-05-19
Lithuania	2026-06-02
Poland	2026-05-11		2026-05-13
Slovakia	2026-05-11		2026-05-13
Spain	2026-05-13		2026-05-14

Results and documents

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

Documents 288 files

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

Type	Title	Version
Protocol (for publication)	D1_Protocol 2025-523123-22-00_Redacted	a
Protocol (for publication)	D1_Protocol addendum EU_2025-523123-22-00_Redacted	3
Protocol (for publication)	D1_Protocol Addendum_2025-523123-22-00_GR_Redacted	3
Protocol (for publication)	D1_Protocol_2025-523123-22-00_GR_Redacted	a
Protocol (for publication)	D4_Study Participant Contact Card_GR	2
Recruitment arrangements (for publication)	1_Recruitment and Informed consent procedure_GR	1
Recruitment arrangements (for publication)	K1_Informed consent and Patient Recruitment Procedure	2.0
Recruitment arrangements (for publication)	K1_Informed consent and patient recruitment procedure_AT	2
Recruitment arrangements (for publication)	K1_Informed consent and patient recruitment procedure_SK	1.0
Recruitment arrangements (for publication)	K1_Recruitment and consenting procedure	1
Recruitment arrangements (for publication)	K1_Recruitment and informed consent procedure	2
Recruitment arrangements (for publication)	K1_Recruitment and informed consent procedure_TC	2
Recruitment arrangements (for publication)	K1_Recruitment Arrangements	1
Recruitment arrangements (for publication)	K1_Recruitment Arrangements	1
Recruitment arrangements (for publication)	K1_Recruitment Arrangements	2.0
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1.0
Recruitment arrangements (for publication)	K1_Recruitment Arrangements	1.0
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	1.1
Recruitment arrangements (for publication)	K1_Recruitment arrangements_lt	v2
Recruitment arrangements (for publication)	K1_Recruitment Arrangements_PL	1.0
Recruitment arrangements (for publication)	K1_Recruitment Arrangments_BG	2
Recruitment arrangements (for publication)	K1_Recruitment material_Brochure	2.0
Recruitment arrangements (for publication)	K1_Recruitment Material_Brochure Master	2
Recruitment arrangements (for publication)	K1_Recruitment material_Flyer	1.0
Recruitment arrangements (for publication)	K1_Recruitment Material_Flyer Master	2
Recruitment arrangements (for publication)	K1_Recruitment Material_Letter Doctor Referral_Master_redacted	1
Recruitment arrangements (for publication)	K1_Recruitment Material_Letter Doctor to Patient_Master	1
Recruitment arrangements (for publication)	K1_Recruitment material_Letter-Doctor-Referral_Redacted	1.0
Recruitment arrangements (for publication)	K1_Recruitment material_Letter-Doctor-to-Patient	1.0
Recruitment arrangements (for publication)	K1_Recruitment material_Poster	2.0
Recruitment arrangements (for publication)	K1_Recruitment Material_Poster Master	2
Recruitment arrangements (for publication)	K1_Recruitment Material_PPT_Doctor Referral_Master_redacted	1
Recruitment arrangements (for publication)	K1_Recruitment material_PPT-Dr-Referral_Redacted	2.0
Recruitment arrangements (for publication)	K1_Recruitment material_Trialbee_Digital Marketing Content	1.0
Recruitment arrangements (for publication)	K1_Recruitment Material_Trialbee_Digital marketing content	1
Recruitment arrangements (for publication)	K1_Recruitment material_Trialbee_Global Privacy Policy	1.0
Recruitment arrangements (for publication)	K1_Recruitment Material_Trialbee_Global Privacy policy	1
Recruitment arrangements (for publication)	K1_Recruitment material_Trialbee_Landing Page	1.0
Recruitment arrangements (for publication)	K1_Recruitment Material_Trialbee_Landing page	1
Recruitment arrangements (for publication)	K1_Recruitment Material_Trialbee_Overview SuppInfo	1
Recruitment arrangements (for publication)	K1_Recruitment material_Trialbee_OverviewSupplementaryInformation	1.0
Recruitment arrangements (for publication)	K1_Recruitment material_Trialbee_Secondary Assessment_Redacted	1.0
Recruitment arrangements (for publication)	K1_Recruitment Material_TrialBee_Secondary Assessment_redacted	1
Recruitment arrangements (for publication)	K1_Recruitment Material_Trialbee_Self assessment_redacted	1
Recruitment arrangements (for publication)	K1_Recruitment material_Trialbee_Self_Assessment_Redacted	1.0
Recruitment arrangements (for publication)	K2_ Recruitment material_Brochure BEDU	1
Recruitment arrangements (for publication)	K2_ Recruitment material_Brochure BEFR	2.0
Recruitment arrangements (for publication)	K2_ Recruitment material_Flyer BEDU	2.0
Recruitment arrangements (for publication)	K2_ Recruitment material_Flyer BEFR	2.0
Recruitment arrangements (for publication)	K2_ Recruitment material_Poster BEFR	2.0
Recruitment arrangements (for publication)	K2_Brochure_Master_RO	1
Recruitment arrangements (for publication)	K2_CT_Outcomes-study-leaflet	1
Recruitment arrangements (for publication)	K2_Flyer_Master_RO	2.0
Recruitment arrangements (for publication)	K2_Letter-Doctor-to-Patient_Master_RO	2.0
Recruitment arrangements (for publication)	K2_List of paticipating sites_SK_clean_Redacted	1.0
Recruitment arrangements (for publication)	K2_Poster_Master_RO	2.0
Recruitment arrangements (for publication)	K2_Recruitment and Informed Consent Procedure	1
Recruitment arrangements (for publication)	K2_Recruitment material_ Brochure	2
Recruitment arrangements (for publication)	K2_Recruitment material_ Flyer	2
Recruitment arrangements (for publication)	K2_Recruitment material_ LetterDoctorReferral_redacted	1
Recruitment arrangements (for publication)	K2_Recruitment material_Brochure	2.0
Recruitment arrangements (for publication)	K2_Recruitment Material_Brochure	3.1
Recruitment arrangements (for publication)	K2_Recruitment material_Brochure_GR	2
Recruitment arrangements (for publication)	K2_Recruitment material_Brochure_Master	2
Recruitment arrangements (for publication)	K2_Recruitment material_Brochure_Master	3
Recruitment arrangements (for publication)	K2_Recruitment material_Brochure_Master_ES	2.1
Recruitment arrangements (for publication)	K2_Recruitment material_Brochure_Master_ITA	2
Recruitment arrangements (for publication)	K2_Recruitment material_Brochure_Master_SK	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Digitalmarketing Content	1
Recruitment arrangements (for publication)	K2_Recruitment Material_Doctor Letter to Patient	1
Recruitment arrangements (for publication)	K2_Recruitment material_Flyer	1.0
Recruitment arrangements (for publication)	K2_Recruitment material_Flyer	2.0
Recruitment arrangements (for publication)	K2_Recruitment Material_Flyer	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Flyer_GR	2
Recruitment arrangements (for publication)	K2_Recruitment material_Flyer_Master	2
Recruitment arrangements (for publication)	K2_Recruitment material_Flyer_Master_ES	2.1
Recruitment arrangements (for publication)	K2_Recruitment material_Flyer_Master_ITA	2
Recruitment arrangements (for publication)	K2_Recruitment material_Flyer_Master_SK	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_LandingPage	1
Recruitment arrangements (for publication)	K2_Recruitment material_Letter Doctor Referral_Master_BG_Redacted	1
Recruitment arrangements (for publication)	K2_Recruitment material_Letter Doctor Referral_Redacted	1.0
Recruitment arrangements (for publication)	K2_Recruitment material_Letter Doctor to Patient	2.1
Recruitment arrangements (for publication)	K2_Recruitment material_Letter doctor to patient BEDU	1.0
Recruitment arrangements (for publication)	K2_Recruitment material_Letter doctor to patient BEFR	1.0
Recruitment arrangements (for publication)	K2_Recruitment material_Letter Doctor to Patient_GR	1
Recruitment arrangements (for publication)	K2_Recruitment material_Letter Doctor to patient_ITA	1
Recruitment arrangements (for publication)	K2_Recruitment material_Letter Doctor to Patient_Master	1
Recruitment arrangements (for publication)	K2_Recruitment material_Letter-Doctor-Referral_Master_SK_Redacted	1.0
Recruitment arrangements (for publication)	K2_Recruitment material_Letter-Doctor-to-Patient	1.0
Recruitment arrangements (for publication)	K2_Recruitment material_Letter-Doctor-to-Patient_Master_ES	1.1
Recruitment arrangements (for publication)	K2_Recruitment material_Letter-Doctor-to-Patient_Master_SK	1.0
Recruitment arrangements (for publication)	K2_Recruitment material_LetterDoctortoPatient	1
Recruitment arrangements (for publication)	K2_Recruitment material_Overview	1
Recruitment arrangements (for publication)	K2_Recruitment material_Poster	2
Recruitment arrangements (for publication)	K2_Recruitment material_Poster	1.0
Recruitment arrangements (for publication)	K2_Recruitment material_Poster	2.0
Recruitment arrangements (for publication)	K2_Recruitment Material_Poster	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Poster BEDU	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Poster_GR	2
Recruitment arrangements (for publication)	K2_Recruitment material_Poster_Master	2
Recruitment arrangements (for publication)	K2_Recruitment material_Poster_Master_ES	2.1
Recruitment arrangements (for publication)	K2_Recruitment material_Poster_Master_ITA	2
Recruitment arrangements (for publication)	K2_Recruitment material_Poster_Master_SK	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_Secondary Assessment_redacted	1.1
Recruitment arrangements (for publication)	K2_Recruitment material_SelfAssessment_redacted	1
Recruitment arrangements (for publication)	K2_Recruitment Material_Trialbee Digital Marketing Content_BEDU	1.0
Recruitment arrangements (for publication)	K2_Recruitment Material_Trialbee Digital Marketing Content_BEFR	1.0
Recruitment arrangements (for publication)	K2_Recruitment Material_Trialbee Global Privacy Policy_BEDU	1.0
Recruitment arrangements (for publication)	K2_Recruitment Material_Trialbee Global Privacy Policy_BEFR	1.0
Recruitment arrangements (for publication)	K2_Recruitment Material_Trialbee Landing Page_BEDU	1.0
Recruitment arrangements (for publication)	K2_Recruitment Material_Trialbee Landing Page_BEFR	1.0
Recruitment arrangements (for publication)	K2_Recruitment Material_Trialbee Overview Supplementary Information_BEDU	1.0
Recruitment arrangements (for publication)	K2_Recruitment Material_Trialbee Overview Supplementary Information_BEFR	1.0
Recruitment arrangements (for publication)	K2_Recruitment Material_Trialbee Secondary Assessment_BEDU_Redacted	1.0
Recruitment arrangements (for publication)	K2_Recruitment Material_Trialbee Secondary Assessment_BEFR_Redacted	1.0
Recruitment arrangements (for publication)	K2_Recruitment Material_Trialbee Self Assessment_BEDU_Redacted	1.0
Recruitment arrangements (for publication)	K2_Recruitment Material_Trialbee Self Assessment_BEFR_Redacted	1.0
Recruitment arrangements (for publication)	K2_Recruitment material_Trialbee_Digital Marketing Content	1.0
Recruitment arrangements (for publication)	K2_Recruitment material_Trialbee_Digital Marketing Content	1
Recruitment arrangements (for publication)	K2_Recruitment material_Trialbee_Digital Marketing Content	1.1
Recruitment arrangements (for publication)	K2_Recruitment Material_Trialbee_Digital Marketing Content_PL	1.0
Recruitment arrangements (for publication)	K2_Recruitment material_Trialbee_Global Privacy Policy	1.0
Recruitment arrangements (for publication)	K2_Recruitment material_Trialbee_Global Privacy Policy	1
Recruitment arrangements (for publication)	K2_Recruitment material_Trialbee_Global Privacy Policy	1
Recruitment arrangements (for publication)	K2_Recruitment Material_Trialbee_Global Privacy Policy_PL	1.0
Recruitment arrangements (for publication)	K2_Recruitment material_Trialbee_Landing Page	1.0
Recruitment arrangements (for publication)	K2_Recruitment material_Trialbee_Landing Page	1
Recruitment arrangements (for publication)	K2_Recruitment material_Trialbee_Overview Supplementary Information	1.0
Recruitment arrangements (for publication)	K2_Recruitment material_Trialbee_Overview Supplementary Information	1
Recruitment arrangements (for publication)	K2_Recruitment material_Trialbee_Overview Supplementary Information	1
Recruitment arrangements (for publication)	K2_Recruitment Material_Trialbee_OverviewSupplementaryInformation_PL	1.0
Recruitment arrangements (for publication)	K2_Recruitment material_Trialbee_Patient Community Outreach	1.0
Recruitment arrangements (for publication)	K2_Recruitment material_Trialbee_Patient Community Outreach	1
Recruitment arrangements (for publication)	K2_Recruitment material_Trialbee_Patient Community Outreach	1
Recruitment arrangements (for publication)	K2_Recruitment Material_Trialbee_Patient Community Outreach_PL	1.0
Recruitment arrangements (for publication)	K2_Recruitment Material_Trialbee_Secondary Assessment_PL_Redacted	1.0
Recruitment arrangements (for publication)	K2_Recruitment material_Trialbee_Secondary Assessment_Redacted	1.0
Recruitment arrangements (for publication)	K2_Recruitment material_Trialbee_Secondary Assessment_Redacted	1
Recruitment arrangements (for publication)	K2_Recruitment material_Trialbee_Secondary Assessment_Redacted	1
Recruitment arrangements (for publication)	K2_Recruitment material_Trialbee_Self Assessment_Redacted	1
Recruitment arrangements (for publication)	K2_Recruitment Material_Trialbee_Self_Assessment_PL_Redacted	1.0
Recruitment arrangements (for publication)	K2_Recruitment material_Trialbee_Self_Assessment_Redacted	1.0
Recruitment arrangements (for publication)	K2_Recruitment material_Trialbee_Self_Assessment_Redacted	1
Recruitment arrangements (for publication)	K2_Recruitment Material_Wervingstekst en beelden voor de rekruteringscampagne Lilly Obesitas Attain	1.1
Recruitment arrangements (for publication)	K2_Recruitment material_ZoomHealth_Privacy Statement	2.0
Recruitment arrangements (for publication)	K2_Recruitment Material_ZoomHealth_Screenshots	2.0
Recruitment arrangements (for publication)	K2_Recruitment material_ZoomHealth_TermsofService	2.0
Recruitment arrangements (for publication)	K2_Recruitment materials _Letter-Doctor-Referral_Master_v1_LT_21Aug2025_redacted	1
Recruitment arrangements (for publication)	K2_Recruitment materials__Flyer_Master_v2_LT_21Aug2025	2
Recruitment arrangements (for publication)	K2_Recruitment materials_Brochure_Master_EST	2.1
Recruitment arrangements (for publication)	K2_Recruitment materials_Brochure_Master_v2_LT_21Aug2025	2
Recruitment arrangements (for publication)	K2_Recruitment materials_Flyer_Master_EST	2.1
Recruitment arrangements (for publication)	K2_Recruitment materials_Letter-Doctor-Referral_Master_ET_Redacted	1.2
Recruitment arrangements (for publication)	K2_Recruitment materials_Letter-Doctor-to-Patient_Master_EST	1.1
Recruitment arrangements (for publication)	K2_Recruitment materials_Letter-Doctor-to-Patient_Master_v1_LT_06Aug2025	1
Recruitment arrangements (for publication)	K2_Recruitment materials_Poster_Master_EST	2.1
Recruitment arrangements (for publication)	K2_Recruitment materials_Poster_Master_v2_LT_21Aug2025	2
Recruitment arrangements (for publication)	K2_Recruitment Materials_Trialbee_Digital Marketing Content	1.0
Recruitment arrangements (for publication)	K2_Recruitment Materials_Trialbee_Global Privacy Policy	1.0
Recruitment arrangements (for publication)	K2_Recruitment Materials_Trialbee_Landing Page	1
Recruitment arrangements (for publication)	K2_Recruitment Materials_Trialbee_Overview Supplementary Information	1.0
Recruitment arrangements (for publication)	K2_Recruitment Materials_Trialbee_Secondary Assessment_Redacted	1
Recruitment arrangements (for publication)	K2_Recruitment Materials_Trialbee_Self_Assessment_Redacted	1
Recruitment arrangements (for publication)	K2_Trialbee_Digital Marketing Content_ro-RO	1
Recruitment arrangements (for publication)	K2_Trialbee_Global Privacy Policy_ro-RO	1
Recruitment arrangements (for publication)	K2_Trialbee_Landing Page_ro-RO	1
Recruitment arrangements (for publication)	K2_Trialbee_OverviewSupplementaryInformation_ro-RO	1
Recruitment arrangements (for publication)	K2_Trialbee_Secondary Assessment_ro-RO_Redacted	1
Recruitment arrangements (for publication)	K2_Trialbee_Self_Assessment_ro-RO_Redacted	1
Recruitment arrangements (for publication)	K3_Additional document_Redacted	1.0
Recruitment arrangements (for publication)	K3_List of planned sites_Redacted	2
Subject information and informed consent form (for publication)	L1_ICF Sponsor Statement_Redacted	1
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_Redacted	1
Subject information and informed consent form (for publication)	L1_Main TLC_DE_Redacted	1.1
Subject information and informed consent form (for publication)	L1_SIS and ICF Addendum genetic samples_Redacted	1.2
Subject information and informed consent form (for publication)	L1_SIS and ICF Main_lt_Redacted	V1.0LTU2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF main_Redacted	1.2
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Subject information and informed consent form (for publication)	L1_SIS and ICF_ Addendum_Pregnant Participant_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_ Addendum_Pregnant Partner	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_Addendum ICF_Redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_GZPW_DPA ICF_Redacted	2
Subject information and informed consent form (for publication)	L1_SIS and ICF_GZPW_Main ICF_Redacted	2
Subject information and informed consent form (for publication)	L1_SIS and ICF_GZPW_Pregnant partner	1
Subject information and informed consent form (for publication)	L1_SIS and ICF_ICF DPA_SK_Redacted	1.1
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Subject information and informed consent form (for publication)	L1_SIS and ICF_Main ICF_ENG_Redacted	1.0
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Subject information and informed consent form (for publication)	L1_SIS and ICF_Main ICF_redacted	1.1
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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_PL_Main ICF_GZPW_Redacted	4.2
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 ICF_SK	1.1
Subject information and informed consent form (for publication)	L1_SIS and ICF_Pregnant Partner_EST_ee	1.0EST2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Pregnant Partner_RU_ee	1.0EST2.0
Subject information and informed consent form (for publication)	L2_ Other subject information material_ZoomHealth documentation	1
Subject information and informed consent form (for publication)	L2_ Other subject information_Participant Contact Card_BG	NA
Subject information and informed consent form (for publication)	L2__Other subject information material_Compensation Information Sheet _v2_LT_06Oct2025_redacted	2
Subject information and informed consent form (for publication)	L2_Compensation Information Sheet_EST	2
Subject information and informed consent form (for publication)	L2_List of ssICF contact details_redacted	1
Subject information and informed consent form (for publication)	L2_Other subject info material_Patient Info Card_SK	1.0
Subject information and informed consent form (for publication)	L2_Other subject information material_Brochure Master_PL	2.0
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Subject information and informed consent form (for publication)	L2_Other subject information material_Confidentiality Notice_BG	2
Subject information and informed consent form (for publication)	L2_Other subject information material_Confidentiality Notice_Netherlands_Redacted	2.0
Subject information and informed consent form (for publication)	L2_Other Subject Information Material_CT Card TY Enrollment_Master_GR	1
Subject information and informed consent form (for publication)	L2_Other Subject Information Material_CT Card TY Screening_Master_GR	1
Subject information and informed consent form (for publication)	L2_Other Subject Information Material_CT GI AE Brochure_Master_GR	1
Subject information and informed consent form (for publication)	L2_Other Subject Information Material_CT Outcomes study leaflet_GR	1
Subject information and informed consent form (for publication)	L2_Other Subject Information Material_CT Supportive Partner Guide_Master_GR	1
Subject information and informed consent form (for publication)	L2_Other subject information material_CT_GI-AE-Brochure	1.0
Subject information and informed consent form (for publication)	L2_Other subject information material_CT_Outcomes-study-leaflet	1.0
Subject information and informed consent form (for publication)	L2_Other subject information material_CT_Outcomes-study-leaflet_Master_SK	1.0
Subject information and informed consent form (for publication)	L2_Other subject information material_CT_Study-Connect-Participant_Edition2_Master_SK	1.0
Subject information and informed consent form (for publication)	L2_Other subject information material_CT_Study-Connect-Participant_Edition4_Master_SK	1.0
Subject information and informed consent form (for publication)	L2_Other subject information material_CT_Supportive-Partner-Guide	1.0
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Subject information and informed consent form (for publication)	L2_Other subject information material_CWM_SHOPPING-LIST	1.0
Subject information and informed consent form (for publication)	L2_Other subject information material_CWM_SHOPPING-LIST_MASTER_SK	1.0
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Subject information and informed consent form (for publication)	L2_Other subject information material_English_Zoom_Privacy Statement	1.0
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Subject information and informed consent form (for publication)	L2_Other subject information material_English_ZoomHealth_TermsOfService	1.0
Subject information and informed consent form (for publication)	L2_Other subject information material_Flyer Master_PL	2.0
Subject information and informed consent form (for publication)	L2_Other subject information material_Letter-Doctor to Patient_PL	1.0
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Subject information and informed consent form (for publication)	L2_Other subject information material_Patient card	1
Subject information and informed consent form (for publication)	L2_Other subject information material_Patient Information Card	2.0
Subject information and informed consent form (for publication)	L2_Other subject information material_Poster Master_PL	2.0
Subject information and informed consent form (for publication)	L2_Other Subject Information Material_Study Connect Participant_Master_GR_Redacted	2
Subject information and informed consent form (for publication)	L2_Other Subject Information Material_Study Guide_Master_GR_Redacted	2
Subject information and informed consent form (for publication)	L2_Other Subject Information Material_Study Medicine Reminder Magnet_Master_GR	2
Subject information and informed consent form (for publication)	L2_Other subject information material_Study-Connect-Participant_Master_SK_Redacted	2.0
Subject information and informed consent form (for publication)	L2_Other subject information material_Study-Connect-Participant_Redacted	2.0
Subject information and informed consent form (for publication)	L2_Other subject information material_Study-Guide_Master_SK_Redacted	2.0
Subject information and informed consent form (for publication)	L2_Other subject information material_Study-Guide_Redacted	2.0
Subject information and informed consent form (for publication)	L2_Other subject information material_Study-Medicine-Reminder-Magnet_Master_SK	2.0
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Subject information and informed consent form (for publication)	L2_Other subject information material_Visit-Card_Master_SK	1.0
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Subject information and informed consent form (for publication)	L2_Other Subject Information_Compensation Information Sheet_BEFR_Redacted	2.0
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Subject information and informed consent form (for publication)	L2_Other subject information_Confidentiality Company Information Notice_LT	2
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Subject information and informed consent form (for publication)	L2_Other subject information_Participant Contact Card _LT_05Oct2025	N/A
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Subject information and informed consent form (for publication)	L2_Study Participant Contact Card_GR	2
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Subject information and informed consent form (for publication)	L3_Patient card	1
Subject information and informed consent form (for publication)	L4_Informed consent and patient recruitment procedure_PL	2.0
Synopsis of the protocol (for publication)	D1_Protocol synopsis _PL_Redacted	a
Synopsis of the protocol (for publication)	D1_Protocol Synopsis AT_2025-523123-22-00_redacted	a
Synopsis of the protocol (for publication)	D1_Protocol synopsis France 2025-523123-22-00_Redacted	a
Synopsis of the protocol (for publication)	D1_Protocol synopsis NL 2025-523123-22-00_Redacted	a
Synopsis of the protocol (for publication)	D1_Protocol synopsis_2025-523123-22-00_BG_Redacted	a
Synopsis of the protocol (for publication)	D1_Protocol Synopsis_2025-523123-22-00_GR_Redacted	a
Synopsis of the protocol (for publication)	D1_Protocol synopsis_2025-523123-22-00_HU_redacted	a
Synopsis of the protocol (for publication)	D1_Protocol synopsis_2025-523123-22-00_LT_26Sep2025 _redacted	a
Synopsis of the protocol (for publication)	D1_Protocol synopsis_2025-523123-22-00_SK_Redacted	a
Synopsis of the protocol (for publication)	D1_Protocol Synopsis_BEDE_2025-523123-22-00_Redacted	a
Synopsis of the protocol (for publication)	D1_Protocol Synopsis_BEDU_2025-523123-22-00_Redacted	a
Synopsis of the protocol (for publication)	D1_Protocol Synopsis_BEFR_2025-523123-22-00_Redacted	a
Synopsis of the protocol (for publication)	D1_Protocol synopsis_CZ_2025-523123-22-00_Redacted	a
Synopsis of the protocol (for publication)	D1_Protocol synopsis_ENG_2025-523123-22-00_Redacted	a
Synopsis of the protocol (for publication)	D1_Protocol synopsis_ES_2025-523123-22-00_Redacted	a
Synopsis of the protocol (for publication)	D1_Protocol synopsis_ITA_2025-523123-22-00_Redacted	a
Synopsis of the protocol (for publication)	D1_Protocol synopsis_RO_2025-523123-22-00_Redacted	a

Application history

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

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-10-16	Netherlands	Acceptable with conditions 2026-02-23	2026-02-24
2	SUBSTANTIAL MODIFICATION	SM-2	2026-03-20		Acceptable 2026-05-07	2026-05-07