Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
4,500
Countries
15
Sites
111
Metabolic Dysfunction-Associated Steatotic Liver Disease
To demonstrate whether the primary intervention is superior to the primary control in reducing the occurrence of MALO.
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
- 24 Mar 2026 → ongoing
- Decision date (initial)
- 2026-02-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-522674-36-00
- WHO UTN
- U1111-1324-0446
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Therapy, Safety, Efficacy
To demonstrate whether the primary intervention is superior to the primary control in reducing the occurrence of MALO.
Conditions and MedDRA coding
Metabolic Dysfunction-Associated Steatotic Liver Disease
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 3
- Have hepatic steatosis (liver fat), diagnosed with MRI
- Have liver fibrosis, diagnosed with non-invasive tests
- (Liver biopsy not needed for enrollment in this trial)
Exclusion criteria 6
- Have any other type of liver disease other than MASLD
- Have a body mass index (BMI) <25 kilogram per square meter (kg/m2)
- Prior cirrhotic liver disease (history of esophageal / gastric varices, ascites, hepatic encephalopathy, historical diagnosis of cirrhosis on liver biopsy)
- Have lost more than 11 pounds within the 3 months prior to screening
- Have a hemoglobin A1c (HbA1c) greater than 10%
- Have type 1 diabetes
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO)
- Composite endpoint comprised of progression to cirrhosis, development of large esophageal varices, gastric varices or development of varices needing treatment, development of ascites, development of hepatic encephalopathy, evidence of active or recent variceal hemorrhage, increase in model for end-stage liver disease (MELD) from ≤12 to ≥15, liver transplantation, all-cause mortality
- [Time Frame: Baseline up to Study Completion (about 224 weeks)]
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 11
PRD12906060 · Product
- Active substance
- LY3437943 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12906057 · Product
- Active substance
- LY3437943 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12906061 · Product
- Active substance
- LY3437943 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12906059 · Product
- Active substance
- LY3437943 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12906058 · Product
- Active substance
- LY3437943 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD11922458 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD11922455 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD11922457 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD11922454 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD11922453 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD11922456 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 2
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
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 18
| Organisation | City, country | Duties |
|---|---|---|
| CRIO Inc ORL-000016098
|
Boston, United States | E-data capture |
| Yprime LLC ORG-100042888
|
Malvern, United States | E-data capture |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
| Clariness GmbH ORG-100045306
|
Hamburg, Germany | Other |
| Clario ORL-000006643
|
Philadelphia, United States | Laboratory analysis |
| Icon Clinical Research LLC ORG-100039864
|
Rochester, United States | Laboratory analysis |
| WCG (Investigator Space) ORL-000014345
|
Indianapolis, United States | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
| Echosens ORG-100045196
|
Paris, France | Laboratory analysis |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Code 13 |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Laboratory analysis |
| WCG Clinical Inc. ORG-100040730
|
Princeton, United States | Other |
| Bioagilytix Labs LLC ORG-100013030
|
Boston, United States | Laboratory analysis |
| Pathai Inc. ORG-100031209
|
Memphis, United States | Laboratory analysis |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
Locations
15 EU/EEA countries · 111 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 15 | 5 |
| Belgium | Ongoing, recruiting | 25 | 11 |
| Bulgaria | Authorised, recruitment pending | 10 | 2 |
| Czechia | Ongoing, recruiting | 25 | 4 |
| France | Ongoing, recruiting | 60 | 16 |
| Germany | Ongoing, recruiting | 70 | 14 |
| Hungary | Ongoing, recruiting | 35 | 3 |
| Italy | Authorised, recruiting | 65 | 11 |
| Netherlands | Authorised, recruitment pending | 30 | 7 |
| Norway | Authorised, recruitment pending | 10 | 1 |
| Poland | Ongoing, recruiting | 90 | 15 |
| Portugal | Authorised, recruitment pending | 10 | 2 |
| Romania | Ongoing, recruiting | 10 | 5 |
| Spain | Ongoing, recruiting | 40 | 13 |
| Sweden | Authorised, recruitment pending | 10 | 2 |
| Rest of world
Mexico, Japan, Switzerland, Ukraine, Israel, New Zealand, Taiwan, Australia, Malaysia, United Kingdom, China, Canada, Turkey, Brazil, Korea, Republic of, Argentina, India, United States
|
— | 3,995 | — |
Investigational sites
Klinik Landstrasse
1st Medical Department, Juchgasse 25, Landstrasse, Vienna
Noe LGA Gesundheit Thermenregion GmbH
Innere Medizin I - Gastroenterologie und Hepatologie, Corvinusring 3-5, 2700, Wiener Neustadt
Medizinische Universität Graz
Department of Internal Medicine, Auenbruggerplatz 15, Graz, Graz
Medizinische Universität Wien
Klinik für innere Medizin III, Abteilung für Gastroenterologie und Hepatologie, Waehringer Guertel 18-20, 1090, Wien
Uniklinikum Salzburg, Landeskrankenhaus, Universitätsklinik für Innere Medizin III der PMU
Innere Medizin I, Müllner Hauptstrasse 48, 5020, Salzburg
Universitair Ziekenhuis Antwerpen
Gastr-enterologie/hepatologie, Drie Eikenstraat 655, 2650, Edegem
Cliniques Universitaires Saint-Luc
Hepato-Gastroenterology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Hopital Erasme
Clinical Research - Gastroenterology Department, Lennikse Baan 808, 1070, Anderlecht
Algemeen Ziekenhuis Delta
Gastroenterology, Deltalaan 1, 8800, Roeselare
Vitaz
Gastroenterology - Hepatology, Moerlandstraat 1, 9100, Sint-Niklaas
UZ Brussel
Gastroenterology - hepatology, Laarbeeklaan 101, 1090, Jette
Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann
Centre Hospitalier Universitaire Brugmann, Arthur Van Gehuchtenplein 4, 1020, Brussels
Universitair Ziekenhuis Gent
Gastroenterology, Corneel Heymanslaan 10, 9000, Gent
Az Maria Middelares Gent
Digestief Centrum, Buitenring-Sint-Denijs 30, 9000, Gent
AZ Oostende vzw
Gastro-enterology, Gouwelozestraat 100, route 10, Oostende
Algemeen Ziekenhuis Groeninge
gastroenterology, President Kennedylaan 4, 8500, Kortrijk
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Department of gastroenterology, Krasno Selo, Bulevard Gen Totleben 21, Sofiya
Multiprofile Hospital For Active Treatment St. Ivan Rilski Gorna Oriahovitsa EOOD
First Internal Department, Ulitsa Otets Paisiy 72, 5100, Gorna Oryahovitsa
Krajska nemocnice Liberec a.s.
Oddeleni gastroenterologie a hepatologie, Husova 1430/34, 460 01, Liberec I-Stare Mesto
Fakultni Nemocnice Ostrava
Oddělení gastroenterologie, hepatologie a pankreatologie,, 17. Listopadu 1790/5, Poruba, Ostrava
Mestska Nemocnice Ostrava Prispevkova Organizace
Interní oddělení, Nemocnicni 898/20a Moravska, 702 00, Ostrava
Vseobecna Fakultni Nemocnice V Praze
N/A, U Nemocnice 499/2, Nove Mesto, Prague
Hopital Beaujon
Hepatology, 100 Boulevard Du General Leclerc, 92110, Clichy
Centre Hospitalier Universitaire d'Angers
Hepato-Gastroenterology, 4 Rue Larrey, Angers, Maine-et-Loire
Hopital Saint Antoine
Hepatology, 184 Rue Du Faubourg Saint Antoine, 75571, Paris Cedex 12
CHU Besançon
Hepatology Consultations, 3, Bd Alexandre Fleming, Doubs
Centre Hospitalier Et Universitaire De Limoges
Hepato-Gastroenterology, 2 Avenue Martin Luther King, 87042, Limoges Cedex 1
Hopitaux Universitaires Pitie Salpetriere
Hepato-Gastroenterology, 47 To 83 Boulevard De L Hopital, 75013, Paris
Centre Hospitalier Universitaire De Lille
Digestive System Diseases Department, Rue Michel Polonovski, 59037, Lille Cedex
Centre Hospitalier Universitaire De Bordeaux
Hepato-Gastroenterology and Digestive Oncology, Avenue De Magellan, 33600, Pessac
Centre De Recherche Clinique Portes Du Sud
Diabetology, 2 Avenue Du 11 Novembre 1918, 69200, Venissieux
Centre Hospitalier Universitaire De Rennes
Liver Diseases Department, 2 Rue Henri Le Guilloux, 35000, Rennes
centre hospitalier lyon sud
Endocrinology, Diabetes and Nutrition, 165, Chemin du Grand Revoyet, Rhône
Centre Hospitalier Universitaire Amiens Picardie
Hepato-Gastroenterology, 1 Rond Point Du Pr Christian Cabrol, 80054, Amiens Cedex 1
CHD Vendee
Gastroenterology, Boulevard Stéphane Moreau, Vendée, La Roche-sur-Yon
Centre Hospitalier Universitaire Dijon Bourgogne - Hôpital François Mitterrand
Hepato-Gastroenterology, 14 Rue Paul Gaffarel, DIJON CEDEX, Dijon
Centre Hospitalier Universitaire De Nice
Hepato-Gastroenterology and Digestive Oncology, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire De Toulouse
CHU Rangueil, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Universitätsmedizin Mannheim
Department of Medicine II, Theodor-Kutzer-Ufer 1-3, Baden-Württemberg, Mannheim
Medizinische Hochschule Hannover
Klinik fuer Gastroenterologie, Endokrinologie, Infektiologie und Hepatologie, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Deutsche Diabetes Forschungsgesellschaft (DDFG) e.V.
Study Coordinating Unit Deutsche Diabetes Forschungsgesellschaft (DDFG) e.V., Auf'm Hennekamp 65, Nordrhein-Westfalen, Düsseldorf
Medical Center - University Of Freiburg
Endocrinology and Diabetology, Internal Medicine II, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Eugastro GmbH
N/A, Johannisplatz 1, Zentrum Sudost, Leipzig
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Medizinische Klinik I, Hepatology, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Universitaetsklinikum des Saarlandes
Gastroenterology; Hepatology; Endocrinology, Kirrberger Straße 100, Saarland, Homburg
Universitaetsklinikum Heidelberg AöR
Innere Medizin I: Klinik für Endokrinologie, Diabetologie, Stoffwechsel und Klinische Chemie, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Universitätsklinikum Leipzig
Section Hepatology, Liebigstrasse 20, 04103, Leipzig
Universitätsmedizin Johannes Gutenberg Universität Mainz
Hepatology and Infectious Diseases, Langenbeckstr. 1, 605/GF/Room 0.271, Mainz
Herz - und Diabeteszentrum Nordrhein - Westfalen, Bad Oeynhausen
N/A, Georgstrasse 11, Nordrhein-Westfalen, Bad Oeynhausen
Charité Campus Virchow-Klinikum
Hepatology, Augustenburger Platz 1, 13353, Berlin
Universitätsklinikum Frankfurt Goethe-Universität
Mediz. Klin. 1-Gastroent. und Hepat., Pneum. und Allerg., Endokrin. und Diabet. sowie Ernährungsmed., Theodor-Stern-Kai 7, Hessen, Frankfurt
Ruppiner Kliniken GmbH
Medizinische Klinik B, Fehrbelliner Strasse 38, 16816, Neuruppin
Obudai Egeszseguegyi Centrum Kft.
N/A, Lajos Utca 74-76, 1036, Budapest III
University Of Debrecen
Klinikai Kozpont, Gasztroenterologiai Klinika, Nagyerdei Korut 98, 4032, Debrecen
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Klinikai Kutatasi Osztaly, Szent Istvan Utca 68, 4400, Nyiregyhaza
Azienda Ospedaliero Universitaria Careggi
Medicina Interna ed Epatologia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Dipartimento di Medicina Interna e Gastroenterologia, Largo Agostino Gemelli 8, 00168, Rome
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Gastroenterologia, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliera Universitaria Federico II Di Napoli
General and Transplant Surgery and Gastroenterology, Via Sergio Pansini 5, 80131, Naples
Humanitas Mirasole S.p.A.
Medicina interna ed Epatologia, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
" UO Medicina interna malattie epatobiliari ed immunoallergologiche", Via Pietro Albertoni 15, 40138, Bologna
Universita Degli Studi Di Padova
Surgery Oncology and Gastroenterology, Via Nicolo' Giustiniani 3, 35128, Padova
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
S.C. Gastroenterologia U., Corso Bramante 88, 10126, Turin
Universita' Campus Bio-medico Di Roma
Medicina Clinica ed Epatologia, Via Alvaro Del Portillo 200, 00128, Rome
University Hospital Policlinico Paolo Giaccone
Dep. Of Internal Medicine and Specialistic, Piazza delle cliniche 2, 90127, Palermo
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
U.O.C. Centro Trasfusionale, Via Francesco Sforza 35, 20122, Milan
Universitair Medisch Centrum Utrecht
Gastro Enterology, Heidelberglaan 100, 3584 CX, Utrecht
Amsterdam UMC Research B.V.
Vascular Medicine Clin Trial Unit, Meibergdreef 9, 1105 AZ, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department of Gastroenterology and Hepatology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Radboud universitair medisch centrum Stichting
Gastroenterology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Brain Research Center Zwolle B.V.
MDL, Dokter Stolteweg 90, 8025 AZ, Zwolle
Leids Universitair Medisch Centrum (LUMC)
Gastroenterology, Albinusdreef 2, 2333 ZA, Leiden
Brain Research Center Den Bosch B.V.
MDL, Statenlaan 37, 5223 LA, 's-Hertogenbosch
Pratia S.A.
N/A, Ul. Dabrowki 13, 40-081, Katowice
Gyncentrum Sp. z o.o.
N/A, Rondo Organizacji Narodow Zjednoczonych 1, 00-124, Warsaw
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
NA, Ul. Woloska 137, 02-507, Warsaw
Uniwersyteckie Centrum Stomatologii I Medycyny Specjalistycznej Sp. z o.o.
N/A, Ul. Marcelinska 42, 60-354, Poznan
Private Practice - Dr. Lukasz Krupa
NA, ul. Fryderyka Szopena 35c, 35-055, Rzeszow
Santa Sp. z o.o.
N/A, Ul. Pilota Stanislawa Wigury 19, 90-302, Lodz
Medical Network Sp. z o.o.
N/A, Ul. Plowiecka 103, 04-501, Warsaw
Szpital Czerniakowski Sp. z o.o.
N/A, Ul. Ulica Stepinska 19/25, 00-739, Warsaw
Gyncentrum Sp. z o.o.
N/A, Ul. Tadeusza Kosciuszki 229, 40-600, Katowice
Care Access Polska Sp. z o.o.
N/A, Ul. Zwierzyniecka 6/u4, 00-719, Warsaw
ID Clinic Arkadiusz Pisula
N/A, Ul. Janowska 19, 41-400, Myslowice
Kresmed Sp. z o. o.
N/A, Ul. Waska 15a, 15-481, Bialystok
Centrum Badan Klinicznych Pi-House Sp. z o.o.
N/A, Ul. Na Zaspe 3, 80-546, Gdansk
Mtz Clinical Research Powered By Pratia
N/A, Ul. Gładka 22, 02-172, Warsaw
Etg Zamosc Sp. z o.o.
N/A, Ul. Gesia 3, 22-400, Zamosc
Unidade Local De Saude De Santa Maria E.P.E.
Internal Medicine, Avenida Professor Egas Moniz, 1649-035, Lisbon
APDP Associacao Protectora Dos Diabeticos De Portugal
Portuguese Diabetes Association, Rua Rodrigo Da Fonseca 1, 1250-189, Lisbon
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj
Gastroenterology, Strada Croitorilor 19-21, 400162, Cluj-Napoca
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta
Gastroenterology, Bulevardul Tomis Nr 145, 900591, Constanta
Spital Judetean De Urgenta Satu Mare
Gastroenterology, Piata Eroilor Revolutiei 1-2, 440055, Satu Mare
Delta Health Care S.R.L.
Gastroenterology, Strada Caramfil G. Nicolae Nr 85a, 014142, Bucharest
Spitalul Clinic Colentina Bucuresti
Gastroenterology, Soseaua Stefan Cel Mare 19-21, 020125, Bucharest
Hospital Universitari Vall D Hebron
Endocrinología, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
University Hospital Son Espases
Endocrinología, Carretera Valldemossa 79, 07120, Palma
Hospital Universitario Y Politecnico La Fe
Digestivo-Hepatología, Avenida Fernando Abril Martorell 106, 46026, Valencia
University Hospital Virgen Del Rocio S.L.
Unidad de ensayos clínicos aparato digestivo, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Clinico Universitario De Valencia
Medicina digestiva, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Infanta Elena
Medicina Interna, Calle Doctor Pedro Naranjo Sn, 21007, Huelva
Area Sanitaria De Ferrol
Endocrinología, Avenida Residencia S/n, 15405, Ferrol
Complexo Hospitalario Universitario A Coruna
Endocrinología, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Germans Trias I Pujol
Servicio de Endocrinologia y Nutrición, Carretera Canyet 1a Planta, 08916, Badalona
Hospital General Universitario Gregorio Maranon
APARATO DIGESTIVO -HEPATOLOGIA, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Universitario La Paz
Hepatología, Paseo De La Castellana 261, 28046, Madrid
Hospital Universitario Marques De Valdecilla
Gastroenterology and Hepatology, Avenida Valdecilla Sn, 39008, Santander
Complexo Hospitalario Universitario De Pontevedra
Consultas Digestivo, Calle Mourente S/n, 36164, Pontevedra
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 | 2026-03-31 | 2026-04-09 | |||
| Belgium | 2026-04-28 | 2026-04-28 | |||
| Czechia | 2026-03-24 | 2026-04-02 | |||
| France | 2026-03-24 | 2026-03-26 | |||
| Germany | 2026-04-15 | 2026-04-22 | |||
| Hungary | 2026-03-25 | 2026-04-01 | |||
| Italy | 2026-05-21 | ||||
| Poland | 2026-04-13 | 2026-04-16 | |||
| Romania | 2026-04-07 | 2026-05-29 | |||
| Spain | 2026-03-24 | 2026-03-27 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 434 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-522674-36-00_Redacted | b |
| Protocol (for publication) | D1_RT01 Protocol 2025-522674-36-00_Redacted | b |
| Protocol (for publication) | D1_TZ01 Protocol 2025-522674-36-00_Redacted | b |
| Protocol (for publication) | D4_Patient Documents Copyright | 1 |
| Recruitment arrangements (for publication) | K1_Informed consent and Patient Recruitment Procedure | 1.0 |
| Recruitment arrangements (for publication) | K1_Informed consent and patient recruitment procedure__BG_v1_08Sep2025 | 1 |
| Recruitment arrangements (for publication) | K1_Informed consent and patient recruitment procedure_PT | 1 |
| Recruitment arrangements (for publication) | K1_List of participating sites | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and consenting procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_NO | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_sponsor_NO | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangment_SE | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangment_Sponsor statemant_SE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangments_BG_v1_13 Aug 2025 | 1 |
| Recruitment arrangements (for publication) | K2_Brochure_Master | 1 |
| Recruitment arrangements (for publication) | K2_Brochure_Master_PT | 2.1 |
| Recruitment arrangements (for publication) | K2_ClinLife_EC-Notes | 4 |
| Recruitment arrangements (for publication) | K2_CT_Outcomes-study-leaflet | 1 |
| Recruitment arrangements (for publication) | K2_CT-MASLD-Overview_Master | 1 |
| Recruitment arrangements (for publication) | K2_EP_Clinical-Trial-Phases_Master | 1 |
| Recruitment arrangements (for publication) | K2_EP_Understanding-Randomization_Master | 1 |
| Recruitment arrangements (for publication) | K2_EP_What-Are-Clinical Trials_Master | 1 |
| Recruitment arrangements (for publication) | K2_EP_What-Is-A-Placebo_Master | 1 |
| Recruitment arrangements (for publication) | K2_Flyer_Master | 1 |
| Recruitment arrangements (for publication) | K2_Flyer_Master_PT | 2.1 |
| Recruitment arrangements (for publication) | K2_Letter-Doctor-to-Patient_Master | 1 |
| Recruitment arrangements (for publication) | K2_Letter-Doctor-to-Patient_Master_PT | 2 |
| Recruitment arrangements (for publication) | K2_List of sites | 1 |
| Recruitment arrangements (for publication) | K2_MALO_Brochure_Master | 2 |
| Recruitment arrangements (for publication) | K2_MALO_Flyer_Master | 2 |
| Recruitment arrangements (for publication) | K2_MALO_Letter-Doctor-to-Patient_Master | 2 |
| Recruitment arrangements (for publication) | K2_MALO_Poster_Master | 2 |
| Recruitment arrangements (for publication) | K2_MASLD_EC_Document_Recruitment_Master | 2 |
| Recruitment arrangements (for publication) | K2_Poster_Master | 1 |
| Recruitment arrangements (for publication) | K2_Poster_Master_PT | 2.1 |
| Recruitment arrangements (for publication) | K2_recruitment and retention_Brochure | 2 |
| Recruitment arrangements (for publication) | K2_recruitment and retention_CL_EC-Notes | 4 |
| Recruitment arrangements (for publication) | K2_recruitment and retention_CL_MASLD_EC_Document_Recruitment | 2 |
| Recruitment arrangements (for publication) | K2_recruitment and retention_Doctor-to-Patient-Letter | 2.1 |
| Recruitment arrangements (for publication) | K2_recruitment and retention_EP_Understanding-Randomization | 1 |
| Recruitment arrangements (for publication) | K2_recruitment and retention_EP_What-Are-Clinical Trials | 1 |
| Recruitment arrangements (for publication) | K2_recruitment and retention_EP_What-Is-A-Placebo | 1 |
| Recruitment arrangements (for publication) | K2_recruitment and retention_Flyer | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment and Retention_HU_CT_Outcomes Study Leaflet | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment and Retention_HU_EP_Clinical Trial Phases | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment and Retention_HU_EP_Understanding Randomization | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment and Retention_HU_EP_What Is A Placebo | 1 |
| Recruitment arrangements (for publication) | K2_recruitment and retention_Poster | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_BEDU | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_BEFR | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Master | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Master_swe | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Master_v2_23Sep2025_BG | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_NO | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clariness EC Document | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical Trial Phases | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Clinical-Trial-Phases | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ClinLife MASLD Patient Facing Information_BEDU | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ClinLife MASLD Patient Facing Information_BEFR | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ClinLife_EC Notes | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ClinLife_EC-Notes | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_ClinLife_EC-Notes | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CT Outcomes Study Leaflet_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CT Outcomes Study Leaflet_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CT_MASLD-overview_Master | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CT_Outcomes-study-leaflet | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CT_Outcomes-study-leaflet_swe | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EP_Clinical-Trial-Phases | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EP_Clinical-Trial-Phases_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EP_Clinical-Trial-Phases_swe | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EP_Understanding-Randomization | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EP_Understanding-Randomization_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EP_Understanding-Randomization_swe | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EP_What-Are-Clinical Trials | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EP_What-Are-Clinical Trials_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EP_What-Are-Clinical Trials_swe | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EP_What-Is-A-Placebo | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EP_What-Is-A-Placebo_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EP_What-Is-A-Placebo_swe | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 2 |
| 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_Flyer_Master | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_Master_v2_23Sep2025_BG | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_NO | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_swe | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Graphic for post | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Graphic for stories | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Brochure | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Flyer | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Letter_Doctor Referral | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Letter_Doctor to Patient | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Poster | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter Doctor to Patient | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter Doctor to Patient_BEDU | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter Doctor to Patient_BEFR | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter Doctor to Patient_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter-Doctor Referral | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter-Doctor to Patient | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter-Doctor-Referral_Master_v1_01Sep2025_BG | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter-Doctor-to-patient_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter-Doctor-to-Patient_Master_v2_23Sep2025_BG | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter-Doctor-to-Patient_swe | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_MALO_Brochure | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_MALO_Flyer | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_MALO_Letter-Doctor-to-Patient | 2.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_MASLD_EC_Document_Recruitment | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_MASLD_EC_Document_Recruitment_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_BEDU | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_BEFR | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_Master | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_Master_v2_23Sep2025_BG | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_NO | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_swe | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PRC Poster 1 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PRC Poster 2 | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PRC Website Text | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Site Additional Flyer_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Text for a post_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Text for a website_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Understanding Randomization_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_What Are Clinical Trials | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_What Are Clinical Trials_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_What Is A Placebo_Master | 1.0 |
| Recruitment arrangements (for publication) | K3_LITES_ Study Participant and Study Partner Survey_Screenshots | 1 |
| Recruitment arrangements (for publication) | K3_LITES_Ethics Cover Letter | 1 |
| Recruitment arrangements (for publication) | K3_LITES_Participant Invitation Email | 1 |
| Recruitment arrangements (for publication) | K3_LITES_Participant_Postcard-During-study | 2 |
| Recruitment arrangements (for publication) | K3_LITES_Participant_Postcard-End-of-study | 2 |
| Recruitment arrangements (for publication) | k3_LITES_Privacy Policy_Master | 1 |
| Recruitment arrangements (for publication) | K3_LITES_Study-Specific Form | 1 |
| Recruitment arrangements (for publication) | K3_LITES_Survey_Participant_Postcard | 2 |
| Recruitment arrangements (for publication) | K3_LITES_Terms of Use | 2 |
| Recruitment arrangements (for publication) | K3_LITES_urvey_Participant_Postcard-Start-of-study | 2 |
| Recruitment arrangements (for publication) | K3_Retention material_ZoomHealth PrivacyStatement_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K3_Retention material_ZoomHealth PrivacyStatement_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K3_Retention material_ZoomHealth Screenshots_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K3_Retention material_ZoomHealth Screenshots_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K3_Retention material_ZoomHealth Terms of Service_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K3_Retention material_ZoomHealth Terms of Service_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main ISA1_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main ISA2_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main Master protocol_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_ICF Sponsor Statement_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Main_PT_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Optional Screening_PT | 1 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_Pregnancy_PT | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_SubStudy RT01_PT_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ICF_CountrySpecific_SubStudy TZ01_PT_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_MALO_Main Informed Consent Form_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_MALO_Optional Pre-screening ICF | 1 |
| Subject information and informed consent form (for publication) | L1_RT01_Informed Consent Form_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_MALO_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_RT01_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_TZ01_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Master ICF_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Extension | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Screening_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening ICF_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF RT01 ICF_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF TZ01 ICF_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Complete Consent Remote Consent Tracking Quick Reference Guide | 4.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DPA | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_eSignature In-Person Consent Quick Reference Guide | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_NO | V1.0NOR3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genetic Addendum_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genetic Addendum_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Getting Started Patient facing landing page_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IQVIA Complete Consent - Participant-Facing Screenshots_Redacted | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IQVIA E2E Privacy Policy | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IQVIA eConsent Submission Letter | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA1 ICF_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ISA2 ICF_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF RT01_Redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF TZ01_Redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_NO_Redacted | V2.0NOR4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 1.4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redated | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Research Subject information and consent form_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BG_bg_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_BG_en_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_MALO_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_MALO_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_MALO_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_RT01_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_TZ01_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MALO Master ICF_BEDU_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MALO Master ICF_BEFR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_MALO Master ICF_ENG_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_OLE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Acitivities Screening_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Acitivities Screening_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Acitivities Screening_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Activity ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Activity ICF | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional OLE ICF | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Screening | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Screening | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional screening | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Screening _BG_bg | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Screening _BG_en | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Screening Addendum_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Screening ICF_Redacted | 1.3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional screening information and consent form | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Screening_NO | V2.0NOR2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Screening_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Screening_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional screening_TC | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant parent | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner or Pregnant Participant information and consent_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner_NO | V1.0NOR3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_QVIA Complete Consent Security and Privacy Quick Reference Guide_Redacted | 1.5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Research Subject information and consent form fot Sub study with retatrutide_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Research Subject information and consent form fot Sub study with tirzepatide_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RT01 ICF_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RT01 ICF_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RT01 ICF_ENG_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RT01 ICF_NO_Redacted | V3.0NOR4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RT01 Sub-study_BG_bg_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RT01 Sub-study_BG_en_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RT01_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RT01_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_RT01_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TZ01 ICF_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TZ01 ICF_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TZ01 ICF_ENG_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TZ01 ICF_NO_Redacted | V2.0NOR4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TZ01 Sub-study_BG_bg_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TZ01 Sub-study_BG_en_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TZ01_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TZ01_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TZ01_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_TZ01_Informed Consent Form_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_confidentiality sheet | 2 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_IFU_RETATRUTIDE | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information material_IFU_TIRZEPATIDE | 1 |
| Subject information and informed consent form (for publication) | L2_ Other subject information_Participant Contact Card_BG_21Aug2025 | NA |
| Subject information and informed consent form (for publication) | L2_Confidentiality Company Information Notice | 1 |
| Subject information and informed consent form (for publication) | L2_Confidentiality Company Information Notice_Phase 3_4_PT | 2 |
| Subject information and informed consent form (for publication) | L2_EP_Clinical-Trial-Phases_Master_PT | 1 |
| Subject information and informed consent form (for publication) | L2_EP_Understanding-Randomization_Master_PT | 1 |
| Subject information and informed consent form (for publication) | L2_EP_What-Are-Clinical Trials_Master_PT | 1 |
| Subject information and informed consent form (for publication) | L2_EP_What-Is-A-Placebo_Master_PT | 1 |
| Subject information and informed consent form (for publication) | L2_Info Re insurance Conditions for Patient | 1 |
| Subject information and informed consent form (for publication) | L2_Instructions for Use_RETATRUTIDE-CT-AI-N1T-MC-RT01_PT | 1 |
| Subject information and informed consent form (for publication) | L2_Instructions for Use_TIRZEPATIDE-CT-AI-N1T-MC-TZ01_PT | 1 |
| Subject information and informed consent form (for publication) | L2_List of ssICF contact details_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Injection-Reminder_MirrorCling_swe | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Study Participant Contact Card_swe | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_7 days eating well | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_7 days of Managing stress | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_7 days of moving more | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_7 days to better sleep | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_7-Days-of-Eating-Well_swe | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_7-Days-of-Managing-Stress_swe | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_7-Days-of-Moving-More_swe | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_7-Days-to-Better-Sleep_Master_swe | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Accu-Chek Instant F Manual | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Compensation Information Sheet_swe | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_compensation sheet_BG | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CompleteConsent Participant-Facing Screenshots_Redacted_BEDU | 1.4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CompleteConsent Participant-Facing Screenshots_Redacted_BEFR | 1.4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CompleteConsent Participant-Facing Screenshots_Redacted_EN | 1.4 |
| 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_swe | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CT MASDL Overview | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CT MASLD Overview_Master_v1_08Aug2025_BG | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CT outcomes | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CT_Card_TY-Enrollment_swe | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CT_Card_TY-Screening_swe | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CT_Visit-Card-Noname_swe | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Eli_Zoom_Translation Letter | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EP CT phases | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EP understanding randomization | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EP What are CT | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EP what is a placebo | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EP_Clinical Trial Phases_v1_29May2025_BG | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EP_Understanding Randomization_v1_23Jun2025_BG | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EP_What-Are-Clinical Trials_Master_v1_29May2025_BG | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EP_What-Is-A-Placebo_Master_v1_16Jun2025_BG | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP Counselor Manual | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP Manual Supplement | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP Module 1 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP Module 10 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP Module 11 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP Module 12 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP Module 13 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP Module 14 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP Module 2 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP Module 3 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP Module 4 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP Module 5 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP Module 6 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP Module 7 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP Module 8 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP Module 9 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP Participant Nutrition Hydration | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HBP Site nutrition hydration | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU TIRZEPATIDE__BG_06Aug2025 | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_RETATRUTIDE_BG_06Aug2025 | NA |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IQVIA eConsent Privacy Policy_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IQVIA eConsent Privacy Policy_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IQVIA eConsent Privacy Policy_ENG | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_LITES Participant invitation email | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_LITES privacy policy | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_LITES Study Participant and Study Partner Survey | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_LITES Study Participant and Study Partner Survey_Screenshots | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_LITES Terms of Use | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_MALO study connect Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_MALO study guide | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_MALO Survey participant postcard_During study | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_MALO_End-of-Study-Letter-noLD_swe | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_MALO_Survey_Participant_Postcard Anytime | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_MALO_Survey_Participant_Postcard Start of study | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_MALO_Survey_Participant_Postcard-End of study | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient-facing landing page_Redacted_BEDU | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient-facing landing page_Redacted_BEFR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient-facing landing page_Redacted_ENG | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Privacy Policy eConsent | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_RegulatorySubmission_CoverLetter | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_RETATRUTIDE_Subject IFU of IP and-or Device_swe | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Retatrutide-CT-IFU-N1T-MC-RT01_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Retatrutide-CT-IFU-N1T-MC-RT01_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Guide | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study guide_Redacted | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Participant Contact Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study-Connect-Participant_swe_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study-Guide_Master_swe | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank you EoT | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thank-You-End_Of_Participation_swe | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_TIRZEPATIDE_Subject IFU of IP and-or Device_swe | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Tirzepatide-CT-IFU-N1T-MC-TZ01_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Tirzepatide-CT-IFU-N1T-MC-TZ01_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_PrivacyStatement | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_Screenshots | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Compensation Information Sheet_BEDU_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Compensation Information Sheet_BEFR_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Compensation Information Sheet_ENG_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_IFU RT01 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_IFU TZ01 | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_IQVIA Complete Consent Security and Privacy QRG_BEDU_Redacted | 1.5 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_IQVIA Complete Consent Security and Privacy QRG_BEFR_Redacted | 1.5 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Patient Card_FRA | 2.0 |
| Subject information and informed consent form (for publication) | L2_Patient Card text | 1 |
| Subject information and informed consent form (for publication) | L2_Patient cards | 1.0 |
| Subject information and informed consent form (for publication) | L2_Study Participant Contact Card_ | 1 |
| Subject information and informed consent form (for publication) | L2_Study Participant Contact Card_PT | 1 |
| Subject information and informed consent form (for publication) | L2_Subject information material_IQVIA Complete Consent - Participant-Facing Screenshots | 1.4 |
| Subject information and informed consent form (for publication) | L2_Subject information material_IQVIA Complete Consent Security and Privacy Quick Reference Guide | 1.5 |
| Subject information and informed consent form (for publication) | L2_Subject information material_IQVIA E2E Privacy Policy | 1 |
| Subject information and informed consent form (for publication) | L2_Subject information material_IQVIA Getting Started Patient-facing landing page | 1.1 |
| Subject information and informed consent form (for publication) | L2_Subject information material_N1T-MC-MALO_eConsent Submission Letter | 1 |
| Subject information and informed consent form (for publication) | L3_ClinLife EC Notes | 4 |
| Subject information and informed consent form (for publication) | L3_Informed consent and patient recruitment procedure | 2 |
| Subject information and informed consent form (for publication) | L3_LITES Ethics Cover letter | 1 |
| Subject information and informed consent form (for publication) | L3_LITES study specific form | 1 |
| Subject information and informed consent form (for publication) | L3_MASLD_EC document_Recruitment | 2 |
| Subject information and informed consent form (for publication) | L3_Patient card | 1 |
| Subject information and informed consent form (for publication) | Subject documentation_ZoomHealth doucmentation | 1 |
| Synopsis of the protocol (for publication) | D1_Master Protocol synopsis PL_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis CZ_MALO_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis CZ_RT01_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis CZ_TZ01_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis MALO_BEDE_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis MALO_BEDU_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis MALO_BEFR_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MALO_BG_2024-520209-38-00_22Sep2025_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis MALO_NL_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis RT01 PL_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis RT01_BEDE_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis RT01_BEDU_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis RT01_BEFR_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis RT01_BG_2024-520209-38-00_22Sep025_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis RT01_NL_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis SE_2025-522674-36-00_main_redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis SE_2025-522674-36-00_sub study with retatrutude_redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis SE_2025-522674-36-00_sub study with tirzepatide_redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis TZ01 _BG_2024-520209-38-00_22Sep2025_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis TZ01 PL_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis TZ01_BEDE_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis TZ01_BEDU_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis TZ01_BEFR_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis TZ01_NL_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ PRT_2025-522674-36-00_TZ01_redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_2025-522674-36-00_ISA_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_2025-522674-36-00_ISA2_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_MALO_AT_2025-522674-36-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_MALO_DE_2025-522674-36-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_MALO_FR_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_MALO_HU 2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_MALO_NO_2025-522674-36-00_Redacted | (a) |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_MALO_RO 2025-522674-36-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PRT_2025-522674-36-00_MALO_redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PRT_2025-522674-36-00_RT01_redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_RT01_AT_2025-522674-36-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_RT01_DE_2025-522674-36-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_RT01_FR_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_RT01_HU 2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_RT01_NO_2025-522674-36-00_Redacted | (a) |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_RT01_RO 2025-522674-36-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_TZ01_AT_2025-522674-36-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_TZ01_DE_2025-522674-36-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_TZ01_FR_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_TZ01_HU 2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_TZ01_NO_2025-522674-36-00_Redacted | (a) |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_TZ01_RO 2025-522674-36-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis ISA1_IT_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis ISA2_IT_2025-522674-36-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol_Synopsis Master_IT_2025-522674-36-00_Redacted | a |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-03 | Germany | Acceptable 2026-01-26
|
2026-01-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-02-24 | Acceptable 2026-01-26
|
2026-02-24 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-26 | Germany | Acceptable | 2026-03-31 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-27 | Acceptable | 2026-04-07 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-03-05 | Acceptable | 2026-05-08 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-03-11 | Acceptable | 2026-04-14 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-03-31 | Acceptable | 2026-04-30 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-08 | 2026-05-08 |