A Study of Tirzepatide (LY3298176) on the Reduction of Morbidity and Mortality in Adults With Obesity (SURMOUNT- MMO)

2022-501744-15-00 Protocol I8F-MC-GPIJ Therapeutic confirmatory (Phase III) Ongoing, recruitment ended

Start 23 Jan 2023 · Status Ongoing, recruitment ended · 13 EU/EEA countries · 210 sites · Protocol I8F-MC-GPIJ

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)
Status Ongoing, recruitment ended
Participants planned 15,000
Countries 13
Sites 210

Obesity, Overweight

Demonstrate whether QW tirzepatide is superior to placebo in reducing morbidity and mortality.

Key facts

Sponsor
Eli Lilly & Co.
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Nutritional and Metabolic Diseases [C18]
Trial duration
23 Jan 2023 → ongoing
Decision date (initial)
2023-01-23
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
Yes

External identifiers

EU CT number
2022-501744-15-00
ClinicalTrials.gov
NCT04657003

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

Demonstrate whether QW tirzepatide is superior to placebo in reducing morbidity and mortality.

Conditions and MedDRA coding

Obesity, Overweight

Study design 1 period

#TitleAllocationBlindingRoles blindedArms
1 Parallel Assignment
N/A
 Randomised Controlled Double [{"id":183480,"code":2,"name":"Investigator"},{"id":183479,"code":1,"name":"Subject"}] Experimental: Tirzepatide: Participants will receive escalated doses of tirzepatide subcutaneously (SC) up to a maximum tolerated dose
Placebo Comparator: Participants will receive tirzepatide matched placebo

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 4

  1. Be overweight or have obesity
  2. Are over age 40 and have cardiovascular disease at least 3 months before study start
  3. Women at least 55 years of age without established heart disease but have cardiovascular risk factors, such as smoke tobacco, abnormal levels of fats (lipids) in the blood, high blood pressure, or kidney disease.
  4. Men at least 50 years of age without established heart disease but have cardiovascular risk factors, such as smoke tobacco, abnormal levels of fats (lipids) in the blood, high blood pressure, or kidney disease.

Exclusion criteria 2

  1. Have type 1 diabetes or type 2 diabetes at the beginning of the study
  2. Have any of the cardiovascular conditions such as: heart attack, stroke, procedure to treat coronary artery disease, or heart failure requiring IV medication or left ventricular assist device within 3 months before the start of the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Time to First Occurrence of Any Component Event of Composite (All-Cause Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Coronary Revascularization, or Heart Failure Events)

Investigational products

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

Test 6

Tirzepatide

PRD11922457 · Product

Active substance
Tirzepatide
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration
SOLUTION FOR INJECTION
Max daily dose
2.14 mg milligram(s)
Max total dose
4.86 g gram(s)
Max treatment duration
324 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Tirzepatide

PRD11922453 · Product

Active substance
Tirzepatide
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration
SOLUTION FOR INJECTION
Max daily dose
2.14 mg milligram(s)
Max total dose
4.86 g gram(s)
Max treatment duration
324 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Tirzepatide

PRD11922458 · Product

Active substance
Tirzepatide
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration
SOLUTION FOR INJECTION
Max daily dose
2.14 mg milligram(s)
Max total dose
4.86 g gram(s)
Max treatment duration
324 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Tirzepatide

PRD11922456 · Product

Active substance
Tirzepatide
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration
SOLUTION FOR INJECTION
Max daily dose
2.14 mg milligram(s)
Max total dose
4.86 g gram(s)
Max treatment duration
324 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Tirzepatide

PRD11922454 · Product

Active substance
Tirzepatide
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration
SOLUTION FOR INJECTION
Max daily dose
2.14 mg milligram(s)
Max total dose
4.86 g gram(s)
Max treatment duration
324 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Tirzepatide

PRD11922455 · Product

Active substance
Tirzepatide
Pharmaceutical form
SOLUTION FOR INJECTION IN PRE-FILLED PEN
Route of administration
SOLUTION FOR INFUSION
Max daily dose
2.14 mg milligram(s)
Max total dose
4.86 g gram(s)
Max treatment duration
324 Week(s)
Authorisation status
Not Authorised
MA holder
ELI LILLY AND COMPANY LIMITED
Paediatric formulation
No
Orphan designation
No

Placebo 1

Placebo to match ly3298176 injection

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 13

OrganisationCity, countryDuties
Pharmaserve Lilly S.A.C.I.
ORG-100005347
 Kifissia, Greece On site monitoring, Code 12, Other, Code 2, Code 5
Iqvia Inc.
ORG-100010622
 Durham, United States On site monitoring
Q Squared Solutions LLC
ORG-100043195
 Durham, United States Laboratory analysis
Vita Verum Medical Bt.
ORG-100039249
 Szekesfehervar, Hungary Other
Greenphire LLC
ORG-100041621
 King Of Prussia, United States Other
Q Squared Solutions Limited
ORG-100042527
 Reading, United Kingdom Laboratory analysis
Q2 Solutions LLC
ORG-100017000
 Ithaca, United States Laboratory analysis
Revise LLC
ORL-000008140
 Austin, Texas, United States Other
Yprime LLC
ORG-100042888
 Malvern, United States E-data capture
Bioagilytix Labs LLC
ORG-100013030
 Durham, United States Laboratory analysis
Trendyminds LLC
ORG-100045580
 Indianapolis, United States Other
Praxis Communications LLC
ORG-100045170
 Buffalo, United States Other
Cleveland Clinic
ORG-100028017
 Cleveland, United States Code 11, Other

Locations

13 EU/EEA countries · 210 investigational sites

By country

CountryMS statusPlanned subjectsSites
Austria Ongoing, recruitment ended 100 7
Belgium Ongoing, recruitment ended 90 9
Czechia Ongoing, recruitment ended 350 14
France Ongoing, recruitment ended 116 13
Germany Ongoing, recruitment ended 626 22
Greece Ongoing, recruitment ended 300 14
Hungary Ongoing, recruitment ended 350 18
Italy Ongoing, recruitment ended 200 16
Netherlands Ongoing, recruitment ended 110 12
Poland Ongoing, recruitment ended 470 23
Romania Ongoing, recruitment ended 375 25
Slovakia Ongoing, recruitment ended 105 7
Spain Ongoing, recruitment ended 490 30
Rest of world
Japan, China, Mexico, Argentina, Turkey, United States, Taiwan, Israel, Canada, Australia, Brazil, United Kingdom, India, Korea, Republic of
 — 11,318 —

Investigational sites

Austria

7 sites · Ongoing, recruitment ended
Medizinische Universitaet Innsbruck
University Hospital for Internal Medicine I, Anichstraße 35, 6020, Innsbruck
Klinik Hietzing
Karl Landsteiner Institute for Metabolic Disease and Nephrology, Wolkersbergenstraße 1, Hietzing, Vienna
Klinik Landstrabe
1st Medical Department, Juchgasse 25, Landstraße, Vienna
Medical University Of Graz
Department of Internal Medicine, Division of Endocrinology and Diabetology, Auenbruggerplatz 2, 8036, Graz
Vivit Institute
VIVIT- Vorarlberg Institute for Vascular Investigation and Treatment, Carinagasse 47, 6800, Feldkirch
Allgemeines Krankenhaus Der Stadt Wien Universitatskliniken
Department of Medicine III, Division of Endocrinology and Metabolism, Währinger Gürtel 18-20, Alsergrund, Vienna
Zentrum Fur Klinische Studien Dr. Hanusch GmbH
Zentrum für Klinische Studien Dr. Hanusch GmbH, Gumpendorfer Straße 95/9, Mariahilf, Vienna

Belgium

9 sites · Ongoing, recruitment ended
Imelda
Associatie Dialyse Endocrinologie, Imeldalaan 9, 2820, Bonheiden
Algemeen Ziekenhuis Damiaan Oostende
Endocrinology, Gouwelozestraat 100, 8400, Ostend
Verenigde Ziekenhuizen van Waas en Durme
Diabetology-Endocrinology, Moerlandstraat 1, 9100, Sint-Niklaas
Jessa Ziekenhuis
Cardiology, Stadsomvaart 11, 3500, Hasselt
UZ Leuven
Endocrinology, Herestraat 49, 3000, Leuven
Onze Lieve Vrouw Hospital
Endocrinology, Moorselbaan 164, 9300, Aalst
Antwerp University Hospital
Endocrinology-Diabetology-Metabolism, Drie Eikenstraat 655, 2650, Edegem
Universitair Ziekenhuis Gent
Endocrinologie, Corneel Heymanslaan 10, 9000, Gent
Hopital Erasme
Endocrinologie, Lennikse Baan 808, 1070, Anderlecht

Czechia

14 sites · Ongoing, recruitment ended
Faracol s.r.o.
Gastroenterology, Obloukova 1335/3, Vrsovice, Prague
Ctc Hodonín s.r.o.
Cardiology, Moravni 4185/16, 695 01, Hodonin
Angionika s.r.o.
Cardiology, Fibichova 586, 252 64, Velke Prilepy
Preventamed s.r.o.
Cardiology, Domovina 774/2, 779 00, Olomouc
Centrum klinickeho vyzkumu s.r.o.
Cardiology, Cechovska 57, 261 01, Pribram VIII
Kardiologicka ambulance MUDr. Ferkl s.r.o.
Cardiology, Palackeho 201, 541 01, Horni Predmesti
Nefrologie s.r.o.
Nephrology, Severozapadni III 388/52, Zabehlice, Prague 4
Cardio Research s.r.o.
Cardiology, J A Bati 5645, 760 01, Zlín
Nemocnice Cesky Krumlov a.s.
Cardiology, Nemocnicni 429, 381 01, Horni Brana
Asclepiades - Interna A Gastroenterologie s.r.o.
Gastroenterology, Dlouha Trida 1134/83, Podlesi, Havirov
Medicus Services s.r.o.
Cardiology, Nadrazni 1317/5, 250 01, Brandys Nad Labem
Gae s.r.o.
Gastroenterology, U Nemocnice 380, 377 01, Jindrichuv Hradec III
Corintez s.r.o.
Cardiology, Seydlerova 2451, 158 00, Prague 13
Pedicor Care s.r.o.
Cardiology, Karla Velcovskeho 1293, 739 32, Vratimov

France

13 sites · Ongoing, recruitment ended
Centre Hospitalier Universitaire De Toulouse
Diabétologie, maladies métaboliques et nutrition, 1 Avenue Du Professeur Jean Poulhes, Tsa 50032, Toulouse Cedex 9
Centre Hospitalier Universitaire De Nice
Département d'Endocrinologie,Diabétologie et Reproduction, 151 Route De Saint Antoine, 06200, Nice
Centre De Recherche Clinique Portes Du Sud
Diabetology, 2 Avenue Du 11 Novembre 1918, 69200, Venissieux
Hospices Civils De Lyon
Endocrinology department, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Centre Hospitalier Sud Francilien
Endocrino-diabetology, 40 Avenue Serge Dassault, 91100, Corbeil Essonnes
Les Hopitaux Universitaires De Strasbourg
Medecine Interne, Endocrinologie et Nutrition, 3 Rue Koeberle, 67000, Strasbourg
Les Hopitaux De Chartres
Unité de recherche clinique cardiologie - diabétologie - néphrologie, 4 Rue Claude Bernard, 28630, Le Coudray
Assistance Publique Hopitaux De Paris
Service de Nutrition, 20 Rue Leblanc, 75015, Paris
Assistance Publique Hopitaux De Paris
Cardiology, 2 Rue Ambroise Pare, 75475, Paris Cedex 10
Centre Hospitalier Universitaire De Limoges
Endocrinologie - Diabétologie - Maladies métaboliques et Médecine de la reproduction, 2 Avenue Martin Luther King, 87000, Limoges
Centre Hospitalier Universitaire Grenoble Alpes
Nephrology - Chronic kidney disease, Boulevard De La Chantourne, Cs 10217 La Tronche, Grenoble Cedex 9
Centre Hospitalier Universitaire De Nantes
Endocrinology & metabolism, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Groupe Sos Sante
Diabetology, 175 Rue Marechal Foch, 71200, Le Creusot

Germany

22 sites · Ongoing, recruitment ended
Zentrum für klinische Studien Bad Homburg
N/A, Louisenstrasse 63, 61348, Bad Homburg
Zentrum für Klinische Studien Praxis Segner - Dr. Braun - Kirsch
Zentrum für Klinische Studien Praxis Segner - Dr. Braun - Kirsch, Hauptstraße 98 66386, St.Ingbert-Oberwürzbach
Praxisinhaber Dr Ulrich Wendisch Dr Dominik Dahl Und Prof Dr Jens Aberle
Gemeinschaftspraxis für Innere Medizin und Diabetologie (Diabeteszentrum Hamburg West), Beselerstraße 2a, Groß Flottbek, Hamburg
Zentrum für klinische Studien Allgäu Oberschwaben. Praxis Sauter & Sauter & Dr. Vorbach
Zentrum für klinische Studien Allgäu Oberschwaben. Praxis Sauter & Sauter & Dr. Vorbach, Herrenstraße 22-24 88239, Wangen
Medical Center - University Of Freiburg
Universitätsklinikum Freiburg Innere Medizin II Abtl. f. Endocrinologie und Diabetologie, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Hausärztliche u. Diabetologische Praxis Pirna
Hausärztliche u. Diabetologische Praxis Pirna, Königsteiner Str. 6B, 6B 01796 Pirna
Gemeinschaftspraxis Prof. Dr. med. Stephan Jacob
Gemeinschaftspraxis Prof. Dr. med. Stephan Jacob, Brombeerweg 6 78048, Villingen-Schweningen
Universitaetsklinikum Tuebingen
Universitätsklinikum Tübingen Innere Medizin IV, Diabetologie, Endokrinologie, Nephrologie, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Ambenet GmbH Das Ambulante Behandlungsnetz
AmBeNet GmbH, Wilhelm-Leuschner-Platz 12, Zentrum-Süd, Leipzig
Schwerpunktpraxis für Diabetes und Ernährungsmedizin
Schwerpunktpraxis für Diabetes und Ernährungsmedizin, Düesbergweg 128 48153 Münster, Germany
University Medical Centre Schleswig-Holstein
Universität zu Lübeck Institut für Endokrinologie und Diabetes, Ratzeburger Allee 160, 23538, Lübeck
Praxis am Markt
Praxis am Markt, Weidkamp 1 45355, Germany, Essen
Herz Und Diabeteszentrum NRW Universitaetsklinik Der Ruhr Universitaet Bochum
Herz- und Diabeteszentrum, Georgstrasse 11, Innenstadt, Bad Oeynhausen
Universitaetsklinikum Frankfurt AöR
Universitätsklinikum Frankfurt Leiter Schwerpunkt Endokrinologie, Diabetologie,, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Innodiab Forschung GmbH
InnoDiab Forschung GmbH, Eleonorastrasse 42, Ruettenscheid, Essen
Institut fuer Diabetesforschung Muenster GmbH
Institut für Diabetesforschung im Franziskus Carré Münster GmbH, Hohenzollernring 70, Herz-Jesu, Muenster
Medizentrum Essen Borbeck
Medizinzentrum Essen Borbeck, Hülsmannstraße 6, Borbeck, Essen
ClinPhenomics CVC GmbH
ClinPhenomics CVC GmbH, Studienzentrum, Alfred-Lippmann-Straße 6, Rohrbach, St. Ingbert
Diabetologikum DDG Ludwigshafen. Die Praxis am Ludwigsplatz
Diabetologikum DDG Ludwigshafen. Die Praxis am Ludwigsplatz, Ludwigsplatz 9, 67059 Ludwigshafen
Velocity Clinical Research GmBH
Standort Berlin, Ansbacher Strasse 17-19, Schoeneberg, Berlin
Clinical Research Hamburg GmbH
Clinical Research, Rahlstedter Bahnhofstraße 33, Rahlstedt, Hamburg

Greece

14 sites · Ongoing, recruitment ended
General Hospital Of Athens G Gennimatas
Endocrinology Department, Messogion Avenue 154, 115 27, Athens
General Hospital Of Lamia
Department of Internal Medicine, Papasiopoulou End, 351 00, Lamia
Laiko General Hospital Of Athens
Diabetes Center, 1st Propaedeutic Internal Medicine Department, Agiou Thoma (goudi) 17, 115 27, Athens
Ippokratio General Hospital Of Thessaloniki
Diabetes Center, 2nd Propaedeutic Internal Medicine Clinic, Konstadinoupoleos 49, 546 42, Thessaloniki
Athens Medical Center S.A.
Department of Internal Medicine, Diabetes and Obesity Unit, Distomou 5-7, 151 25, Maroussi
Athens Medical Center S.A.
Iatriko Paleou Falirou, Diabetes Department, Areos 36, 175 62, Paleo Faliro
University General Hospital Attikon
2nd Propaedeutic Internal Medicine Department, Rimini Street 1, 124 62, Athens
University General Hospital Of Heraklion
Department of Internal Medicine, Stavrakia And Voutes, 715 00, Heraklion
General University Hospital Of Larissa
Endocrinοlogy Clinic and Metabolic Diseases, P. O. Box 1425, 411 10, Larissa
University General Hospital Of Ioannina
2nd Department of Internal Medicine, Niarchou Stavrou Avenue, 455 00, Ioannina
Thermi Clinic S.A.
Internal Medicine Department, 14th Kms N Moudanion, 570 01, Thessaloniki
Euromedica General Clinic Of Thessaloniki
Endocrinology Diabetes & Metabolism Department, Kallas Marias 11, Gravias 2, Thessaloniki
General Hospital Of Thessaloniki Papageorgiou
1st Department of Internal Medicine, Ring Road Of Thessaloniki, Ministry Of Pavlos Melas, Efkarpia
University General Hospital Of Thessaloniki Ahepa
1st Propaedeutic Department of Internal Medicine, 1st St Kiriakidis Str, 546 36, Thessaloniki

Hungary

18 sites · Ongoing, recruitment ended
Obudai Egeszsegugyi Centrum Kft.
Obudai Egeszsegugyi Centrum, Lajos Utca 74-76, 1036, Budapest III
Nagykanizsai Kanizsai Dorottya Korhaz
Kanizsai Dorottya Korhaz, Diabetes Department, (3.ep, Fszt. 12-13. ajto), Szekeres J. u. 2-8., 8800, Nagykanizsa
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Belgyógyászat- Angiológia-Nefrológiai osztály Kardiovaszkuláris ambulancia, Nagyvarad Ter 1, 1097, Budapest Ix
Ujpesti Egeszsegugyi Nonprofit Kft.
Ujpesti Egeszsegugyi Szolgaltato Nonprofit Kft., Gorgey Artur Ut 30, 1046, Budapest IV
Central Hospital Of Northern Pest Military Hospital
Central Hospital Of Northern Pest Military Hospital, Robert Karoly Korut 44, 1134, Budapest XIII
Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet
Bajcsy- Zsilinszky Korhaz és Rendelointezet, III. Belgyogyaszat, Maglodi Ut 89-91, Kerulet, Budapest
Allergo-Derm Bakos Kft.
Allergo-Derm Bakos kft, Kelen Utca 1 C Ihaz 4 Em 3, 1138, Budapest XIII
Kistarcsai Flor Ferenc Korhaz
Pest Megyei Flor Ferenc Korhaz, V. Belgyógyászat (6. em.), Semmelweis Ter 1, 2143, Kistarcsa
Strazsahegy Medicina Bt.
Strazsahegy Medicina Bt., Duna Sor 2, 2120, Dunakeszi
Komaromi Selye Janos Korhaz
Selye Janos Korhaz-Rendelointezet, Diabetologia, Beothy Zsolt Utca 4, 2900, Komarom
Minoseg Orvoscsoport Kft.
Minoseg Orvoscsoport Kft., Narcisz Utca 27, 8200, Veszprem
Trantor 99 Bt.
Trantor 99 BT., Damjanich Janos Ut 127, Kerulet, Budapest XXI
Szent Margit Rendelointezet
Szent Margit Rendelointezet Nonprofit Kft., Diabetologiai Szakrendelo, Vorosvari ut 88-96. fszt. 8. ajto, 1032, Budapest
Clinexpert Kft.
Clinexpert Kft., Fszt, Kaszasdulo Utca 5, Budapest III
University Teaching Hospital Markusovszky
Markusovszky Egyetemi Oktatokorhaz, Diabetologia Szakrendeles, Markusovszky Str. 5, 9700, Szombathely
DRC Kft.
DRC Gyogyszervizsgalo Kozpont, Szabadsag Utca 18, 1028, Budapest
Semmelweis University
Semmelweis Egyetem, Belgyogyaszati és Onkologiai Klinika, Koranyi Sandor Utca 2/a, Kerulet, Budapest VIII
University Of Debrecen
Debreceni Egyetem Klinikia Kozpont, Belgyogyaszati Intezet A epulet, foldszint, Nagyerdei Korut 98, 4032, Debrecen

Italy

16 sites · Ongoing, recruitment ended
Azienda Ospedaliera Policlinico Universitario Tor Vergata
UOC di Medicina Interna - Centro medico dell’obesità. Loc. 1, Viale Oxford 81, 00133, Rome
Azienda Socio Sanitaria Territoriale Lariana
UOC di Malattie Endocrine e Diabetologia, Via Napoleona 60, 22100, Como
University Hospital Of Ferrara
Centro dello Scompenso Loc. 1, Cona, Via Aldo Moro 8, Ferrara
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Piazza delle Cliniche 2,, Via Del Vespro 129, 90127, Palermo
Careggi University Hospital
Largo G.Alessandro Brambilla 3, Nuovo ingresso Careggi (NIC), padiglione 1 (seminterrato), SOD Diabe, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliera Di Padova
Clinica Medica 3, Via Nicolo' Giustiniani 2, 35128, Padova
Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza Di Torino
Dipartimento di Scienze Mediche, Corso Bramante 88, 10126, Turin
Azienda Ospedaliero Universitaria Pisana
SD Dietologia Universitaria Loc. 1, Via Roma 67, 56126, Pisa
Fondazione Policlinico Universitario Campus Bio-Medico
Diabetes and Endocrinology Department, Via Alvaro Del Portillo N 200, 00128, Rome
Magna Graecia University Of Catanzaro
U.O. Clinica Medica Loc. 1, Viale Europa Localita Germaneto, 88100, Catanzaro
S Orsola Policlinic Hospital
Via Pietro Albertoni 15, Building 11, Bologna, Italia, 40138, Via Giuseppe Massarenti 9, 40138, Bologna
University Hospital Consorziale Policlinico
Piazza Giulio Cesare 11, Padiglione Chini 3rd floor, Bari, Italia 70124, Piazzale Giulio Cesare 11, 70124, Bari
Azienda Ospedaliero Universitaria Pisana
Department of Clinical and Experimental Medicine - Endocrine Unit Loc. 1, Via Roma 67, 56126, Pisa
IRCCS Policlinico San Donato
Piazza Edmondo Malan, Milano, Italia, 20097, Piazza Edmondo Malan 2, 20097, San Donato Milanese
Ospedale Santa Maria Goretti Latina
UOC Diabetologia Universitaria Loc. 1, Viale Michelangelo Buonarroti, 04100, Latina
ARNAS Civico Di Cristina Benfratelli
Dipartimento di Medicina Clinica Loc. 1, Piazza Nicola Leotta 4, 90127, Palermo

Netherlands

12 sites · Ongoing, recruitment ended
Stichting Meander Medisch Centrum
Internal Medicine, Maatweg 3, 3813 TZ, Amersfoort
Ziekenhuis Rivierenland
Cardiology, President Kennedylaan 1, 4002 WP, Tiel
Martini Ziekenhuis / Centrum Bijzondere Tandheelkunde Martini Ziekenhuis
Cardiology, Van Swietenplein 1, 9728 NT, Groningen
Stichting Sint Franciscus Vlietland Groep
Cardiology, Kleiweg 500, 3045 PM, Rotterdam
Elkerliek Ziekenhuis
Cardiology, Wesselmanlaan 25, 5707 HA, Helmond
General Practitioners Research Institute B.V.
General Practitioners, Professor Enno Dirk Wiersmastraat 5, 9713 GH, Groningen
Stichting Treant Ziekenhuiszorg
Cardiology, Dr. G.h. Amshoffweg 1, 7909 AA, Hoogeveen
Stichting Ziekenhuisgroep Twente
Cardiology, Zilvermeeuw 1, 7609 PP, Almelo
Spaarne Gasthuis
Cardiology, Spaarnepoort 1, 2134 TM, Hoofddorp
Reinier De Graaf
Cardiology, Reinier De Graafweg 5, 2625 AD, Delft
Albert Schweitzer Ziekenhuis
Internal Medicine, Albert Schweitzerplaats 25, 3318 AT, Dordrecht
Stichting Rijnstate Ziekenhuis
Internal Medicine, Wagnerlaan 55, 6815 AD, Arnhem

Poland

23 sites · Ongoing, recruitment ended
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Centrum Badan Klinicznych PI-House sp. z o.o. Loc. 6, Ul. Na Zaspe 3, 80-546, Gdansk
Terpa Sp. z o.o. sp.k.
Gabinety TERPA, Ul. Pogodna 34, 20-337, Lublin
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Centrum Terapii Wspołczesnej, Ul. Przedzalniana 66, 90-338, Lodz
Ekamed Sp. z o.o.
NA, Aleja Krasnicka 2j/u1, 20-718, Lublin
Centrum Medyczne Neuromed Sp. z o.o.
Centrum Medyczne NEUROMED, Ul. Jana Biziela 14, 85-163, Bydgoszcz
Legeartis Poradnie Specjalistyczne Sp. z o.o.
SN ZOZ Lege Artis Poradnia Diabetologiczna, Ul. Mlynowa 17, 15-404, Bialystok
Prywatny Gabinet Lekarski Centrum Medyczne Diabetika Dorota Mlodawska-Choluj
Centrum Medyczne "Diabetika", Ul. Marsz. Ferdynanda Focha Nr 12 Lok 4, 26-610, Radom
Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Sp. p.
Centrum Kliniczno- Badawcze, Ul. Studzienna 35-36/a, 82-300, Elblag
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET, Ul. Rusznikarska 17, 31-261, Cracow
4 Wojskowy Szpital Kliniczny Z Poliklinika Samodzielny Publiczny Zaklad Opieki Zdrowotnej We Wroclawiu
4 Wojskowy Szpital Kliniczny z Polikliniką, SPZOZ, Klinika Chorob Wewnetrznych, Ul. Rudolfa Weigla 5, 53-114, Wroclaw
Gaja Poradnie Lekarskie Maciej Wiza
Gaja Poradnie Lekarskie Maciej Wiza, osiedle Orła Białego 103, 61-251, Poznań
Osrodek Diabetologiczny Popula Elzbieta Poplawska Grazyna Laszewska Sp. j.
NSZOZ Osrodek Diabetologiczny Popula SC, Aleja Jozefa Pilsudskiego 4a Lok 1, 15-445, Bialystok
Osteo Medic s.c. Artur Racewicz Jerzy Supronik
Osteo Medic, Ul. Wiejska 81, 15-351, Bialystok
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
NZOZ Centrum Medyczne KERmed, Ul. Krolowej Jadwigi 16, 85-231, Bydgoszcz
Ilkowski I Partnerzy Spolka Partnerska Lekarzy
Neuro-Kard, Ul. Wierzbowa 2/2, 61-853, Poznan
Diab Serwis Popenda Sp. j.
Diab serwis Popenda Spółka Jawna, Ul. Jozefa Ryszki 51, 41-516, Chorzow
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji W Warszawie
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji w Warszawie, Ul. Woloska 137, 02-507, Warsaw
Centrum Medyczne Intercor Sp. z o.o.
INTERCOR, Ul. Kasztanowa 57, 85-605, Bydgoszcz
Drelich Grzegorz Centrum Kardiologiczne Kardio-Med
NA, Ul. Kreznicka 165, 20-518, Lublin
NBR Polska Tomasz Klodawski
NBR Polska, Aleja Wincentego Witosa 31, 00-710, Warsaw
Ambulatorium Sp. z o.o.
Ambulatorium Sp. z o.o., Ul. Topolowa 28, 82-300, Elblag
Niepubliczny Zaklad Opieki Zdrowotnej Przychodnia Specjalistyczna A.Wittek H.Rudzki Spolka Jawna
NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki, Ul. Piotra Niedurnego 50 D, 41-709, Ruda Slaska
Wojewodzki Zespol Specjalistycznej Opieki Zdrowotnej
Wojewodzki Zespol Specjalistycznej Opieki Zdrowotnej, Ul. Dobrzynska 21/23, 50-403, Wroclaw

Romania

25 sites · Ongoing, recruitment ended
Clinica Korall S.R.L.
Diabetes, P-Ta Eroii Revolutiei, Corp A Apartament M-2 Nr 22, Satu Mare
Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop Lavinia
Diabetes, Nutrition and Metabolic disease, Strada Cosbuc George Nr 25a, Ap. 2, Baia Mare
Spitalul Clinic Judetean De Urgenta Craiova
Cardiology Clinic, Strada Tabaci Nr 1, 200642, Craiova
Sal Med S.R.L.
Cardiology, Block P7 Scara E Etaj P, Strada Traian, Pitesti
Cabinet Medical Dr Geru S.R.L.
Diabetes, Nutrition and Metabolic disease, Aleea Lirei Nr 1, Ap. 2, Timisoara
Diabdana S.R.L.
Diabetes, Calea Republicii Nr 77, 410147, Oradea
Hightech Medical Services S.R.L.
Diabetes, Nutrition and Metabolic disease, Sector 1, Alexandra Ioan Cuza Blvd 76, Bucharest
Cmi Cardiologie-Dr. Mercea Corina Delia
Cardiology, Bulevardul Independentei 10/43, 430123, Baia Mare
Milena Sante S.R.L.
Diabetes, Nutrition and Metabolic disease, Strada Balcescu Nicolae Nr 31, 800001, Galati
Diamed Obesity S.R.L.
Diabetes and Metabolic diseases, Gheorghe Doja Nr 73, 800291, Galati
Gama Diamed S.R.L.
Diabetes, Nutrition and Metabolic disease, T S Saveanu Nr 1, 905500, Mangalia
Minimed S.R.L.
Diabetes, Strada Pacii Nr.7, 600274, Bacau
Consultmed S.R.L.
Diabetes and Metabolic diseases, Block 550, Soseaua Pacurari 70, Jassi
Institutul De Boli Cardiovasculare Timisoara
Cardiology, Strada Adam Gheorghe Nr 13a, 300310, Timisoara
Medicali`s S.R.L.
Cardiology, Strada Cernauti 13, 300362, Timisoara
Grandmed S.R.L.
Diabetology, Calea Republicii Nr 32, Ap. 1, Oradea
Cardio Med S.R.L.
Cardiology 2, Strada Spania Nr 35a, 200513, Craiova
Nicodiab S.R.L.
Diabetes, Nutrition and Metabolic disease, Strada Titeica Gheorghe 202-204, 020305, Bucharest
Mediab S.R.L.
Diabetes, Nutrition and Metabolic disease, Apartament I-II, Strada Marinescu Gheorghe Nr 8a, Targu Mures
Cmi Dr. Podoleanu Cristian
Cardiology, Aleea Cornisa Nr 5, Ap. 4, Targu Mures
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Diabetes, Nutrition and Metabolic disease, Strada Crisului Nr. 1, 500283, Brasov
Nutrilife S.R.L.
Diabetes and Metabolic diseases, Strada Dobrogeanu-Gherea Constantin 10-12, 013764, Bucharest
Societatea Civila Medicala Dr. Paveliu
Diabetes, Nutrition and Metabolic disease, Strada Dr. Iatropol Panait 24, 050538, Bucharest
Gensan S.R.L.
Diabetes, Nutrition and Metabolic disease, Strada Cooperatorilor No 21, 550041, Sibiu
Dianutrilife Medica S.R.L.
Diabetes, Nutrition and Metabolic disease, Str Dumbrava 1b, 107400, Paulesti

Slovakia

7 sites · Ongoing, recruitment ended
AMBORA s.r.o.
AMBORA s.r.o., Ambulancia vnútorného lekárstva, J. Krala 341/45, 036 01, Martin
Benimed s.r.o.
BENIMED s.r.o. Kardiologická ambulancia, Bratislavska 63/2835, 921 01, Piestany
Pentes s.r.o.
PENTES s.r.o., Kardiologická ambulancia, Mojs 8, 010 01, Mojs
Jm - Interna s.r.o.
JM-Interna s.r.o, Velicna 356, 027 54, Velicna
MediTask s.r.o.
MediTask s.r.o., Ambulancia diabetológie a porúch látkovej premeny a výživy, Vajnorska 1354/40, Nove Mesto, Bratislava
Funkystuf s.r.o
FUNKYSTUFF, s.r.o., Ambulancia diabetológie a porúch látkovej premeny a výživy, Zalesna 9, 940 02, Nove Zamky
DIA MED CENTRUM s.r.o.
DIA-MED CENTRUM s.r.o., Ambulancia diabetológie a porúch látkovej premeny a výživy, Tajovskeho 8568/3, 010 01, Zilina

Spain

30 sites · Ongoing, recruitment ended
Hospital Universitari Vall D Hebron
Endocrinology and metabolism, Passeig De La Vall D Hebron 119-129, 08035, Barcelona
Hospital Clinic De Barcelona
Endocrinology and metabolism, Calle Villarroel 170, 08036, Barcelona
Area Sanitaria De Ferrol
Endocrinology and metabolism, Avenida Residencia S/n, 15405, Ferrol
Hospital Universitario Clinico San Cecilio
Endocrinology and metabolism, Avenida Del Conocimiento S/n, Poligono Industrial De Ciencias De La Salud, Granada
Hospital Quironsalud Infanta Luisa
Endocrinology and metabolism, Calle De San Jacinto 87, 41010, Sevilla
Hospital Universitario Central De Asturias
Endocrinology and metabolism, Avenida De Roma S/n, 33011, Oviedo
Hospital Universitario Dr Peset Aleixandre
Endocrinology and metabolism, Avinguda De Gaspar Aguilar 90, 46017, Valencia
Complexo Hospitalario Universitario A Coruna
Endocrinology and metabolism, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Virgen Del Camino
Internal Medicine, Carretera De Chipiona Sn, 11540, Sanlucar De Barrameda
Hospital Universitario Basurto
Endocrinology and metabolism, Montevideo Etorbidea 16-18, 48013, Bilbao
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
Endocrinology and metabolism, Calle Alejo Fernandez 9, 41003, Sevilla
Hospital Virgen De Las Montanas
Internal Medicine, Avenida Ambulatorio S/n, 11650, Villamartin
University Clinic Of Navarra
Endocrinology and metabolism, Avenida De Pio XII 36, 31008, Pamplona
Hospital Universitario De La Ribera
Endocrinology and metabolism, Carretera Corbera 1, 46600, Alzira
Hospital Universitario Fundacion Alcorcon
Endocrinology and metabolism, Calle Budapest 1, 28022, Madrid
Hospital Universitario Fundacion Jimenez Diaz
Endocrinology and metabolism, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Virgen De La Victoria
Endocrinology and metabolism, Calle Del Arroyo Teatinos S N, 29010, Malaga
University Hospital Of Canary Islands
Endocrinology and metabolism, Carretera Cuesta Taco S/N, 38320, San Cristobal De La Laguna
Clinica Juaneda S.A.
Endocrinology and metabolism, Calle Company 30, 07014, Palma
Hospital Universitario Quironsalud Madrid
Endocrinology and metabolism, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario Ramon Y Cajal
Internal Medicine, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Quironsalud Malaga
Endocrinology and metabolism, Avenida Imperio Argentina 1, 29004, Malaga
Hospital Clinico Universitario De Valencia
Endocrinology and metabolism, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario Torrecardenas
Endocrinology and metabolism, Calle Paraje Torrecardenas S/n, 04009, Almería
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Endocrinology and metabolism, Av. Alcalde Rovira Roure 80, 25198, Lleida
Hospital General Universitario De Valencia
Endocrinology and metabolism, Avenida Del Tres Cruces 2, 46014, Valencia
Area De Salud De Leon Y El Bierzo
Endocrinology and metabolism, C/ Altos De Nava S/n, 24080, León
Hospital General Universitario Gregorio Maranon
Endocrinology and metabolism, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Nisa Sevilla Aljarafe
Endocrinology and metabolism, Avenida Placido Fernandez Viagas S/n, 41950, Castilleja De La Cuesta
Hospital Universitario Marques De Valdecilla
Endocrinology and metabolism, 5 Planta, Avenida Valdecilla S/n, Santander

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 2023-02-16 2023-03-06 2023-12-15
Belgium 2023-02-07 2023-02-20 2023-12-15
Czechia 2023-02-03 2023-02-13 2023-12-15
France 2023-01-24 2023-01-27 2023-12-15
Germany 2023-01-24 2023-01-26 2023-12-15
Greece 2023-02-07 2023-02-09 2023-12-15
Hungary 2023-01-23 2023-01-27 2023-12-15
Italy 2023-02-13 2023-03-06 2023-12-15
Netherlands 2023-01-31 2023-02-20 2023-12-15
Poland 2023-02-01 2023-02-06 2023-12-15
Romania 2023-02-16 2023-02-22 2023-12-15
Slovakia 2023-02-08 2023-02-13 2023-12-15
Spain 2023-01-25 2023-01-30 2023-12-15

Results and documents

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

Documents 469 files

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

TypeTitleVersion
Protocol (for publication) D1_ Protocol 2022-501744-15-00_Redacted d
Protocol (for publication) D1_Protocol_2022-501744-15-00_GR_Redacted d
Protocol (for publication) GPIJ_Harmonized Clinical Protocol-Greece_redacted 1
Protocol (for publication) Patient Facing Documents_For Publication_for MS NL only 1
Recruitment arrangements (for publication) 2_Lilly_SURMOUNT-MMO_Patient Invite-to-Trial Letter_GR 1
Recruitment arrangements (for publication) 2_Lilly_SURMOUNT-MMO_Recruitment Brochure_GR 1
Recruitment arrangements (for publication) 2_Lilly_SURMOUNT-MMO_Recruitment Poster_GR 1
Recruitment arrangements (for publication) GPIJ_CZ_List of planned sites_05Aug2022_Redacted 1
Recruitment arrangements (for publication) GPIJ_CZ_Recruitment and ICF procedure_05Aug2022 1
Recruitment arrangements (for publication) GPIJ_Recruitment and Informed consent procedure_GREECE_Redacted 1
Recruitment arrangements (for publication) GPIJ_Recruitment Arrangements_04Aug2022_Redacted 1
Recruitment arrangements (for publication) GPIJ_Recruitment Arrangements_Redacted 1
Recruitment arrangements (for publication) K1_Recruitment arrangements procedure_french_v2.0_TC 2.0
Recruitment arrangements (for publication) K1_Recruitment arrangements_redacted 1.0
Recruitment arrangements (for publication) K1_Recruitment Procedure 4.0
Recruitment arrangements (for publication) K1_Recruitment Procedure_TC 4.0
Recruitment arrangements (for publication) K2_ Recruitment material Recruitment Brochure 1.0
Recruitment arrangements (for publication) K2_ Recruitment material_ES_Patient Invite-to-Trial Letter 1.0
Recruitment arrangements (for publication) K2_ Recruitment material_ES_Recruitment Brochure 1.0
Recruitment arrangements (for publication) K2_ Recruitment material_ES_Recruitment Poster 1.0
Recruitment arrangements (for publication) K2_GI Side Effect Card_M_DE 1.0
Recruitment arrangements (for publication) K2_List of participating sites_Redacted 1.0
Recruitment arrangements (for publication) K2_Recruitment Material Family Engagement Brochure 1.0
Recruitment arrangements (for publication) K2_Recruitment material Family Engagement Brochure 1
Recruitment arrangements (for publication) K2_Recruitment Material GI Side Effect Card 1.0
Recruitment arrangements (for publication) K2_Recruitment material GI Side Effect Card 1
Recruitment arrangements (for publication) K2_Recruitment Material Making Healthy Food Choices 1.0
Recruitment arrangements (for publication) K2_Recruitment material Making Healthy Food Choices 1
Recruitment arrangements (for publication) K2_Recruitment Material Recruitment Brochure 1.0
Recruitment arrangements (for publication) K2_Recruitment material Recruitment Brochure 1
Recruitment arrangements (for publication) K2_Recruitment Material Recruitment Poster 1.0
Recruitment arrangements (for publication) K2_Recruitment material Recruitment Poster 1
Recruitment arrangements (for publication) K2_Recruitment Material Staying Fit Through An Active Lifestyle 1.0
Recruitment arrangements (for publication) K2_Recruitment material Staying Fit Through An Active Lifestyle 1
Recruitment arrangements (for publication) K2_Recruitment Material Thank You Card 1.0
Recruitment arrangements (for publication) K2_Recruitment material Thank You Card 1
Recruitment arrangements (for publication) K2_Recruitment material_Clinical Trial Ancillary Supply List 1
Recruitment arrangements (for publication) K2_Recruitment material_Dr-to-Patient Invitation Letter 1
Recruitment arrangements (for publication) K2_Recruitment material_Dr-to-Patient Invitation Letter 1
Recruitment arrangements (for publication) K2_Recruitment Material_Dr-to-Patient Invitation Letter_DU 1.0
Recruitment arrangements (for publication) K2_Recruitment Material_Dr-to-Patient Invitation Letter_FR 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Dr-to-Patient Invitation Letter_NL_v1_16Mar2023 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Dr-to-Patient Invitation Letter_TC 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Family Engagement Brochure 1
Recruitment arrangements (for publication) K2_Recruitment material_Family Engagement Brochure 1.0
Recruitment arrangements (for publication) K2_Recruitment Material_Family Engagement Brochure_DU 1
Recruitment arrangements (for publication) K2_Recruitment Material_Family Engagement Brochure_FR 1
Recruitment arrangements (for publication) K2_Recruitment material_Family Engagement Brochure_M_DE 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Family Engagement Brochure_NL_v1_01Feb2023 1.0
Recruitment arrangements (for publication) K2_Recruitment material_GI Side Effect Card 1
Recruitment arrangements (for publication) K2_Recruitment material_GI Side Effect Card 1.0
Recruitment arrangements (for publication) K2_Recruitment Material_GI Side Effect Card_DU 1
Recruitment arrangements (for publication) K2_Recruitment Material_GI Side Effect Card_FR 1
Recruitment arrangements (for publication) K2_Recruitment material_GP to Patient letter GPRI_NL_v1_01Feb2023_Redacted 2.0
Recruitment arrangements (for publication) K2_Recruitment material_GP to Patient letter GPRI_TC_Redacted 2.0
Recruitment arrangements (for publication) K2_Recruitment Material_Making Healthy Food Choices_BEDU 1.0
Recruitment arrangements (for publication) K2_Recruitment Material_Making Healthy Food Choices_BEFR 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Patient Invite-to-Trial Letter 1
Recruitment arrangements (for publication) K2_Recruitment material_Patient Invite-to-Trial Letter_DE 1
Recruitment arrangements (for publication) K2_Recruitment material_Recruitment Brochure 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Recruitment Brochure 1
Recruitment arrangements (for publication) K2_Recruitment material_Recruitment Brochure 1
Recruitment arrangements (for publication) K2_Recruitment material_Recruitment Brochure 1.0
Recruitment arrangements (for publication) K2_Recruitment Material_Recruitment Brochure_DU 1
Recruitment arrangements (for publication) K2_Recruitment Material_Recruitment Brochure_FR 1
Recruitment arrangements (for publication) K2_Recruitment material_Recruitment Brochure_M_DE 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Recruitment Brochure_NL_v1_01Feb2023 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Recruitment Brochure_TC 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Recruitment Poster 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Recruitment Poster 1
Recruitment arrangements (for publication) K2_Recruitment material_Recruitment Poster 1
Recruitment arrangements (for publication) K2_Recruitment material_Recruitment Poster 1.0
Recruitment arrangements (for publication) K2_Recruitment Material_Recruitment Poster_DU 1
Recruitment arrangements (for publication) K2_Recruitment Material_Recruitment Poster_FR 1
Recruitment arrangements (for publication) K2_Recruitment material_Recruitment Poster_M_DE 1.0
Recruitment arrangements (for publication) K2_Recruitment material_Recruitment Poster_NL_v1_01Feb2023 2.0
Recruitment arrangements (for publication) K2_Recruitment material_Recruitment Poster_TC 2.0
Recruitment arrangements (for publication) K2_Recruitment material_SK_Family Engagement Brochure 1.0
Recruitment arrangements (for publication) K2_Recruitment material_SK_GI Side Effect Card 1.0
Recruitment arrangements (for publication) K2_Recruitment material_SK_Making Healthy Food Choices 1.0
Recruitment arrangements (for publication) K2_Recruitment material_SK_Recruitment Brochure 1.0
Recruitment arrangements (for publication) K2_Recruitment material_SK_Recruitment Poster 1.0
Recruitment arrangements (for publication) K2_Recruitment material_SK_Staying Fit Through An Active Lifestyle 1.0
Recruitment arrangements (for publication) K2_Recruitment material_SK_v1_Thank You Card 1.0
Recruitment arrangements (for publication) K2_Recruitment Material_Staying Fit Through An Active Lifestyle_BEDU 1.0
Recruitment arrangements (for publication) K2_Recruitment Material_Staying Fit Through An Active Lifestyle_BEFR 1.0
Recruitment arrangements (for publication) List of planned Sites and Subject_ITA redacted 3.0
Recruitment arrangements (for publication) List of planned sites_CZ_Redacted 2
Recruitment arrangements (for publication) List of Planned Sites_redacted 2.0
Recruitment arrangements (for publication) Recruitment and Informed consent procedure 1
Recruitment arrangements (for publication) Recruitment and Informed consent procedure 2.0
Recruitment arrangements (for publication) Recruitment Arrangements__ENG_Redacted 1
Recruitment arrangements (for publication) Recruitment Arrangements_ENG_Redacted 1
Recruitment arrangements (for publication) Recruitment Arrangements_ENG_Redacted 1
Recruitment arrangements (for publication) Recruitment Arrangements_ENG_Redacted 1
Recruitment arrangements (for publication) Recruitment Arrangements_Redacted 2.0
Recruitment arrangements (for publication) Recruitment Arrangements_Redacted 1
Recruitment arrangements (for publication) Recruitment arrangements-RO GPIJ 1
Subject information and informed consent form (for publication) 1 Patient Facing Documents_For Publication_v1_26Aug2022_ENG 1
Subject information and informed consent form (for publication) Clinical Trial Ancillary Supply List for I8F-MC-GPIJ__Redacted 1.0
Subject information and informed consent form (for publication) Clinical Trial Ancillary Supply List for I8F-MC-GPIJ_Redacted 2
Subject information and informed consent form (for publication) Clinical Trial Ancillary Supply List for I8F-MC-GPIJ_Redacted 2
Subject information and informed consent form (for publication) Clinical Trial Ancillary Supply List for I8F-MC-GPIJ_Redacted 2
Subject information and informed consent form (for publication) Clinical Trial Ancillary Supply List for I8F-MC-GPIJ_Redacted 1
Subject information and informed consent form (for publication) Clinical Trial Ancillary Supply List for I8F-MC-GPIJ_v2_05Aug2022_Redacted 2
Subject information and informed consent form (for publication) Clinical Trial Ancillary Supply List__Redacted 2
Subject information and informed consent form (for publication) Clinical Trial Ancillary Supply List_redacted 2
Subject information and informed consent form (for publication) Clinical Trial Ancillary Supply List_v2_05Aug2022_Redacted 2
Subject information and informed consent form (for publication) ConneX France Travel Contact Card 3.0
Subject information and informed consent form (for publication) ConneX France Travel Ref Guide 3.0
Subject information and informed consent form (for publication) Consent Procedure 2.0
Subject information and informed consent form (for publication) Country Subject Directions for Use_DFU of IP 1
Subject information and informed consent form (for publication) Czech_Greenphire ClinCard Msg Templates_ROW v6_0 Feb 2018_CZ 6
Subject information and informed consent form (for publication) Czech_Greenphire ClinCard Travel Ref Guide for Subjects_v3_CZ 3
Subject information and informed consent form (for publication) Czech_Greenphire Travel Contact Card_2_CZ_July2016 2
Subject information and informed consent form (for publication) Czech_Greenphire_ClinCard_Card_Carrier_V1__CZ 1
Subject information and informed consent form (for publication) Czech_Greenphire_ClinCard_Cardholder_FAQ_EU_V3_CZ 3
Subject information and informed consent form (for publication) Czech_Greenphire_Fee_Schedule_V4_CZ 4
Subject information and informed consent form (for publication) Czech_Republic_-_EC_packet_w_Data_Laws_as_applied_to_GP_v6_ENG 6
Subject information and informed consent form (for publication) D4_Patient Facing Documents_For Publication_ENG 1.0
Subject information and informed consent form (for publication) EC packet with Data Privacy as applied to GP 7
Subject information and informed consent form (for publication) EC_packet_w_Data_Privacy_as_applied_to_GP 7.0
Subject information and informed consent form (for publication) General ConneX EC packet with Data Privacy as applied to GP 2
Subject information and informed consent form (for publication) General_ConneX_EC_Data_Privacy 1.0
Subject information and informed consent form (for publication) General_ConneX_EC_packet_w_Data_Privacy_as_applied_to_GP 2
Subject information and informed consent form (for publication) General_ConneX_EC_packet_w_Data_Privacy_as_applied_to_GP 2
Subject information and informed consent form (for publication) General_ConneX_EC_packet_w_Data_Privacy_as_applied_to_GP_0 1
Subject information and informed consent form (for publication) General_ConneX_EC_packet_w_Data_Privacy_as_applied_to_GP_v2_CZ 2
Subject information and informed consent form (for publication) Genetic Addendum Informed Consent Form 1
Subject information and informed consent form (for publication) Genetic addendum Informed Consent Form_Redacted 1.1
Subject information and informed consent form (for publication) Genetic addendum Informed Consent Form_Track changed_Redacted 1.1
Subject information and informed consent form (for publication) German_Germany _ ConneX Germany Travel Contact Card 1
Subject information and informed consent form (for publication) German_Germany _ ConneX Germany Travel Ref Guide for Subjects 1
Subject information and informed consent form (for publication) German_Germany _ Greenphire ClinCard Msg Templates _ ROW 1
Subject information and informed consent form (for publication) German_Germany _ Greenphire_ClinCard_Card_Carrier 1
Subject information and informed consent form (for publication) German_Germany _ Greenphire_ClinCard_Cardholder_FAQ_EU 1
Subject information and informed consent form (for publication) German_Germany _ Greenphire_Fee_Schedule 1
Subject information and informed consent form (for publication) Germany_EC_packet_Data_Privacy_as_applied_to_GP 1
Subject information and informed consent form (for publication) GPIJ_Clinical Trial Ancillary Supply List_Redacted 2
Subject information and informed consent form (for publication) GPIJ_Country Reimbursement ICF Addendum_DE_Redacted 1.1
Subject information and informed consent form (for publication) GPIJ_ICF Pregnant Partner_Redacted 1.1
Subject information and informed consent form (for publication) GPIJ_ICF Pregnant Partner_v1.1_1Dec2022_TC_Redacted 1.1
Subject information and informed consent form (for publication) GPIJ_ICF_Redacted 1.2
Subject information and informed consent form (for publication) GPIJ_List of ssICF contact details__DE_Redacted 1
Subject information and informed consent form (for publication) GPIJ_Main Country Informed Consent Form_DE_Final_Redacted 4.1
Subject information and informed consent form (for publication) GPIJ_Main ICF_v1.2_1Dec2022_TC_Redacted 1.2
Subject information and informed consent form (for publication) GPIJ_Patient card_Ebenbichler__DE 1
Subject information and informed consent form (for publication) GPIJ_Patient card_Hanusch__DE 1
Subject information and informed consent form (for publication) GPIJ_Patient card_KautzkyWiller__DE 1
Subject information and informed consent form (for publication) GPIJ_Patient card_Ludvik__DE 1
Subject information and informed consent form (for publication) GPIJ_Patient card_Sourij__0__DE 1
Subject information and informed consent form (for publication) GPIJ_Patient card_Stulnig__0__DE 1
Subject information and informed consent form (for publication) GPIJ_Patient card_Vonbank_DE 1
Subject information and informed consent form (for publication) GPIJ_SK_Main ICFtracked changes 1.1
Subject information and informed consent form (for publication) Greenphire ClinCard Card Carrier_redacted 1
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Synopsis of the protocol (for publication) D1_Protocol synopsis_AT_2022-501744-15-00 c
Synopsis of the protocol (for publication) D1_Protocol synopsis_AT_2022-501744-15-00_Redacted d
Synopsis of the protocol (for publication) D1_Protocol synopsis_AT_2022-501744-15-00_TC c
Synopsis of the protocol (for publication) D1_Protocol synopsis_CZ_2022-501744-15-00 b
Synopsis of the protocol (for publication) D1_Protocol synopsis_CZ_2022-501744-15-00_Redacted d
Synopsis of the protocol (for publication) D1_Protocol synopsis_CZ_2022-501744-15-00_TC b
Synopsis of the protocol (for publication) D1_Protocol Synopsis_ES_2022-501744-15-00 b
Synopsis of the protocol (for publication) D1_Protocol Synopsis_ES_2022-501744-15-00_Redacted d
Synopsis of the protocol (for publication) D1_Protocol synopsis_FRA_2022-501744-15-00 c
Synopsis of the protocol (for publication) D1_Protocol synopsis_FRA_2022-501744-15-00_Redacted d
Synopsis of the protocol (for publication) D1_Protocol synopsis_FRA_2022-501744-15-00_TC c
Synopsis of the protocol (for publication) D1_Protocol synopsis_PL 2022-501744-15-00_Redacted d
Synopsis of the protocol (for publication) D1_Protocol_Synopsis_IT_2022-501744-15-00_redacted d
Synopsis of the protocol (for publication) GPIJ Justification for Placebo _Redacted 1
Synopsis of the protocol (for publication) GPIJ Protocol Synopsis_BEFR_TC b
Synopsis of the protocol (for publication) GPIJ Protocol Synopsis_GER 2.0
Synopsis of the protocol (for publication) GPIJ Protocol Synopsis_PL_TC b
Synopsis of the protocol (for publication) GPIJ Protocol_Synopsis_BEDU_TC b
Synopsis of the protocol (for publication) GPIJ_Protocol Synopsis_BEGER_TC b
Synopsis of the protocol (for publication) GPIJ_Protocol Synopsis_GER_TC 2.0
Synopsis of the protocol (for publication) GPIJ_Protocol Synopsis_PL b
Synopsis of the protocol (for publication) Protocol synopsis _RO TC b
Synopsis of the protocol (for publication) Protocol Synopsis_BE DE b
Synopsis of the protocol (for publication) Protocol Synopsis_BE FR b
Synopsis of the protocol (for publication) Protocol synopsis_RO b
Synopsis of the protocol (for publication) Protocol_Synopsis_BE NL b
Synopsis of the protocol (for publication) Protocol_Synopsis_ITA b
Synopsis of the protocol (for publication) Protocol_Synopsis_ITA_TC b

Application history

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

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2022-09-27 Germany Acceptable
2022-12-22
 2022-12-22
2 NON SUBSTANTIAL MODIFICATION NSM-1 2023-03-14 Acceptable
2022-12-22
 2023-03-14
3 SUBSTANTIAL MODIFICATION SM-1 2023-04-28 Germany Acceptable
2023-06-26
 2023-06-27
4 SUBSTANTIAL MODIFICATION SM-2 2023-11-23 Acceptable 2024-01-16
5 SUBSTANTIAL MODIFICATION SM-3 2023-12-11 Acceptable 2024-02-12
6 SUBSTANTIAL MODIFICATION SM-4 2023-12-11 Acceptable 2024-02-13
7 SUBSTANTIAL MODIFICATION SM-5 2023-12-15 Acceptable 2024-02-06
8 SUBSTANTIAL MODIFICATION SM-6 2024-01-29 Germany Acceptable 2024-02-07
9 SUBSTANTIAL MODIFICATION SM-7 2024-07-08 Germany Acceptable
2024-09-19
 2024-09-19
10 NON SUBSTANTIAL MODIFICATION NSM-2 2024-10-30 Acceptable
2024-09-19
 2024-10-30
11 SUBSTANTIAL MODIFICATION SM-8 2024-11-14 Acceptable 2024-12-31
12 SUBSTANTIAL MODIFICATION SM-9 2024-12-03 Acceptable 2025-01-24
13 NON SUBSTANTIAL MODIFICATION NSM-3 2025-01-28 2025-01-28
14 SUBSTANTIAL MODIFICATION SM-10 2025-01-31 Acceptable 2025-02-17
15 NON SUBSTANTIAL MODIFICATION NSM-4 2025-04-09 Acceptable 2025-04-09
16 SUBSTANTIAL MODIFICATION SM-11 2025-04-10 Germany Acceptable 2025-04-14
17 NON SUBSTANTIAL MODIFICATION NSM-5 2025-05-02 Germany Acceptable 2025-05-02
18 NON SUBSTANTIAL MODIFICATION NSM-6 2025-05-09 Acceptable 2025-05-09
19 SUBSTANTIAL MODIFICATION SM-12 2025-07-11 Germany Acceptable
2025-10-02
 2025-10-02
20 NON SUBSTANTIAL MODIFICATION NSM-7 2025-10-23 Acceptable
2025-10-02
 2025-10-23
21 SUBSTANTIAL MODIFICATION SM-14 2025-10-31 Acceptable 2025-12-10
22 SUBSTANTIAL MODIFICATION SM-15 2025-11-12 Germany Acceptable 2025-12-16
23 SUBSTANTIAL MODIFICATION SM-16 2026-01-13 Germany Acceptable
2026-04-01
 2026-04-01
24 NON SUBSTANTIAL MODIFICATION NSM-8 2026-04-30 Acceptable
2026-04-01
 2026-04-30

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