Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
465
Countries
5
Sites
31
Obesity
To demonstrate that tirzepatide is superior to placebo for glycemic control.
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
- 8 Jul 2025 → ongoing
- Decision date (initial)
- 2025-06-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-519685-51-00
- WHO UTN
- U1111-1317-7618
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Safety
To demonstrate that tirzepatide is superior to placebo for glycemic control.
Conditions and MedDRA coding
Obesity
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-504413-80-00 | I8F-MC-GPHP: Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly versus Placebo in Adolescent Participants Who have Obesity or are Overweight with Weight-Related Comorbidities: A Randomized, Double-Blind Trial (SURMOUNT-ADOLESCENTS) | Eli Lilly & Co. |
| 2023-506082-60-00 | I8F-MC-GPIG - Tirzepatide Study of Renal Function in People with Overweight or Obesity and Chronic Kidney Disease with or without Type 2 Diabetes: Focus on Kidney Hypoxia in Relation to Fatty Kidney Disease using Multiparametric Magnetic Resonance Imaging (TREASURE-CKD) | Eli Lilly & Co. |
| 2023-507655-30-00 | I8F-MC-GPIX: Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for the Treatment of Obesity and Weight-Related Comorbidities in Adolescents: A Randomized, Double-Blind, Placebo- Controlled Trial (SURMOUNT-ADOLESCENTS-2) | Eli Lilly & Co. |
| 2023-507846-96-00 | I8F-MC-GPGN: The Effect of Tirzepatide versus Dulaglutide on Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes (SURPASS-CVOT) | Eli Lilly & Co. |
| 2022-501744-15-00 | I8F-MC-GPIJ: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Tirzepatide on the Reduction of Morbidity and Mortality in Adults with Obesity | Eli Lilly & Co. |
| 2022-501073-40-00 | I8F-MC-GPHE: A Randomized, Open-Label, Parallel-Group, Two-Arm, Phase 4 Study to Evaluate the Long-Term Efficacy and Safety of Tirzepatide Compared with Intensified Conventional Care in Adults When Initiating Treatment Early in the Course of Type 2 Diabetes (SURPASS-EARLY) | Eli Lilly & Co. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Minimum Age: 18 Years
- Have had type 1 diabetes and on insulin treatment for at least one year
- Have blood glucose levels within allowed limits for study participation
- Have obesity or overweight
Exclusion criteria 3
- Have had 2 or more hospitalization for very high blood glucose in the past 6 months.
- Have had 1 or more emergency treatment for very low blood glucose in the past 3 months.
- Are receiving or planning to receive treatment for diabetic eye disease.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from Baseline in Hemoglobin A1c (HbA1c) [Time Frame: Baseline, Week 40]
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
PRD11922458 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 72 Week(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 USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 72 Week(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 USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 72 Week(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 USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 72 Week(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 USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 72 Week(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 USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 72 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
Placebo 1
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 16
| Organisation | City, country | Duties |
|---|---|---|
| R Square Technology Inc. ORL-000009672
|
Chesterbrook, United States | Code 10 |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| R&G US Inc. ORG-100048358
|
North Potomac, United States | Code 10 |
| ACI Clinical WCG Clinical ORL-000013564
|
Bala Cynwyd PA, United States | Code 10 |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
| IQVIA ORL-000013396
|
Durham NC, United States | Other |
| IQVIA ORL-000013395
|
Durham NC, United States | On site monitoring |
| IQVIA Connected Devices ORL-000013402
|
Durham NC, United States | Laboratory analysis |
| Clinical Ink ORL-000013398
|
Horsham PA, United States | Data management |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
| Q Squared Solutions Limited ORG-100042527
|
Livingston, United Kingdom | Laboratory analysis |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| Q2 ORL-000013403
|
Durham NC, United States | Laboratory analysis |
| Pharmaserve Lilly S.A.C.I. ORG-100005347
|
Kifisia, Greece | On site monitoring, Code 12, Other, Code 2, Code 5 |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
Locations
5 EU/EEA countries · 31 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruitment ended | 45 | 6 |
| France | Ongoing, recruitment ended | 44 | 8 |
| Greece | Ongoing, recruitment ended | 40 | 4 |
| Romania | Ongoing, recruitment ended | 30 | 8 |
| Spain | Ongoing, recruitment ended | 35 | 5 |
| Rest of world
Argentina, Canada, Brazil, United States, Mexico
|
— | 271 | — |
Investigational sites
ResTrial s.r.o.
N/A, Zhorelecka 514/2, Bohnice, Prague 8
MUDr. Tomáš Edelsberger, Diabetologie
N/A, Náměstí Minoritů 86/7, 794 01, Krnov
INTENDIA klinika s.r.o.
N/A, Palackeho Trida 198, 537 01, Chrudim
Diabetologicke centrum s.r.o.
N/A, Krapkova 5, 779 00, Olomouc
Aidin VK s.r.o.
N/A, Na Naspech 78, 753 01, Hranice I-Mesto
Milan Kvapil s.r.o.
N/A, Michnova 1622/4, Chodov, Prague
Hôpital Le Creusot - Groupe SOS - Site Foch
Diabétologie, 26 Rue d'Harfleur, Le Creusot
Centre Hospitalier Universitaire de Grenoble
Service Endocrinologie Diabetologie Nutrition", Bd de la Chantourne, Pavillon Ecrins - Accueil 2e étage
Centre Hospitalier Universitaire Rouen
Endocrinology, diabetes and metabolic syndrome, 147 Avenue Du Marechal Juin, 76230, Bois-Guillaume
Hôpital de la Conception
Service de Nutrition, Endocrinologie, Maladies Métaboliques, 147 Boulevard Baille, Marseille
Centre Hospitalier Sud Francilien
Endocrino diabétologie, 40 Avenue Serge Dassault, 91106, Corbeil Essonnes Cedex
CHU Rangueil
Diabétologie, maladies métaboliques et nutrition, 1, Avenue du Professeur Jean Poulhès
Assistance Publique Hopitaux De Paris
Diabétologie et Endocrinologie, 2 Rue Ambroise Pare, 75010, Paris
Centre De Recherche Clinique Portes Du Sud
Diabétologie, 2 Avenue Du 11 Novembre 1918, 69200, Venissieux
Athens Medical Center S.A.
Diabetes Department, Areos 36, 175 62, Paleo Faliro
Euromedica General Clinic Of Thessaloniki
Endocrinology Diabetes and Metabolism Department, Kallas Marias 11, Gravias 2, Thessaloniki
Athens Medical Center S.A.
Department of Internal Medicine, Diabetes and Obesity Unit, Distomou 5-7, 151 25, Maroussi
Ippokratio General Hospital Of Thessaloniki
Diabetes Center, 2nd Propaedeutic Internal Medicine Clinic, Konstadinoupoleos 49, 546 42, Thessaloniki
Diabet Med S.R.L.
Diabetes, Nutrition and Metabolic Diseases, Calea Rahovei No 322d, 050913, Bucharest
Consultmed S.R.L.
Diabetes, Nutrition and Metabolic Diseases, Block 550, Soseaua Pacurari 70, Jassi
Mariodiab Clinic S.R.L.
Diabetes, Nutrition and Metabolic Diseases, Block 75 Scara A, Bulevardul 15 Noiembrie Nr 75, Brasov
Clinica Diabnutrimed S.R.L.
Diabetes, Nutrition and Metabolic Diseases, Strada Sfantul Petru Tei 60a, 020358, Bucharest
Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop Lavinia
Diabetes, Nutrition and Metabolic Diseases, Strada George Cosbuc no. 25A / 2, Baia Mare,, Maramureș
Diamed Obesity S.R.L.
Diabetes, Nutrition and Metabolic Diseases, Gheorghe Doja Nr 73, 800291, Galati
Rinart Diab S.R.L.
Diabetes, Nutrition and Metabolic Diseases, Strada Matei Basarab 65, 130168, Targoviste
Sanamed Hospital S.R.L.
Diabetes, Nutrition and Metabolic Diseases, Calea Plevnei 159, 060013, Bucharest
University Hospital Virgen Del Rocio S.L.
Endocrinology and Nutrition, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Clinic De Barcelona
Endocrinology and Nutrition, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario De Badajoz
Endocrinology and Nutrition, Avenida Elvas S/n, 06006, Badajoz
Hospital Universitario Ramon Y Cajal
Endocrinology and Nutrition, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Germans Trias I Pujol
Endocrinology and Nutrition, Carretera Canyet 1a Planta, 08916, Badalona
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 |
|---|---|---|---|---|---|
| Czechia | 2025-07-08 | 2025-07-15 | 2025-12-12 | ||
| France | 2025-09-01 | 2025-09-05 | 2025-12-12 | ||
| Greece | 2025-08-26 | 2025-08-28 | 2025-12-12 | ||
| Romania | 2025-07-16 | 2025-07-24 | 2025-12-12 | ||
| Spain | 2025-07-09 | 2025-07-10 | 2025-12-12 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Corrective measures 1 · Art. 77 CTR
Corrective measure CM-FR-0001
- Member state
- France
- Publication date
- 2025-07-25
- Type
- 3
- Reason
- 7
- Immediate action required
- Yes
- Justification
- The sponsor is requested to submit a specific SM Part II only in France in order to update its CTA in line with the documentation approved during the appeal procedure within 10 days after the submission of this corrective measure (if applicable).
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 99 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-519685-51-00_Redacted | b |
| Protocol (for publication) | D1_Protocol_2024-519685-51-00_GR_Redacted | b |
| Protocol (for publication) | D4_Patient facing documents_Copyright statement | 1.0 |
| Protocol (for publication) | D4_Study Participant Contact Card_GR | 1 |
| Recruitment arrangements (for publication) | 1_Recruitment and Informed consent procedure_GR | 1 |
| Recruitment arrangements (for publication) | K1_Annex 3_Recruitment and consenting procedure_Annex 3 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_CZ_15Jan25 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment material Trialbee Landing Page | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Trialbee Overview Supplementary Information | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment material Trialbee Privacy Policy | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment material Trialbee Secondary Assessment And Communication | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment material Trialbee Self Assessment | 1.0 |
| Recruitment arrangements (for publication) | K1_Recuritment material Trialbee Digital Marketing Content | 1 |
| Recruitment arrangements (for publication) | K2_Brochure_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Brochure_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Flyer_Master | 1 |
| Recruitment arrangements (for publication) | K2_Flyer_Master | 1 |
| Recruitment arrangements (for publication) | K2_Letter-Doctor-Referral_Master | 1 |
| Recruitment arrangements (for publication) | K2_Letter-Doctor-To-Patient_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Letter-Doctor-To-Patient_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Poster_Master | 1 |
| Recruitment arrangements (for publication) | K2_Poster_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Doctor Referral | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure_FRA | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_GR_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_GR | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Poster_FRA | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_GR | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Study Guide_FRA | 1.0 |
| Recruitment arrangements (for publication) | K2_Trialbee_Digital Marketing Content | 1 |
| Recruitment arrangements (for publication) | K2_Trialbee_Landing Page | 2 |
| Recruitment arrangements (for publication) | K2_Trialbee_OverviewSupplementaryInformation | 1 |
| Recruitment arrangements (for publication) | K2_Trialbee_PrivacyPolicy | 1 |
| Recruitment arrangements (for publication) | K2_Trialbee_SecondayAssessmentAndCommunication | 2 |
| Recruitment arrangements (for publication) | K2_Trialbee_Self Assessment | 1 |
| Recruitment arrangements (for publication) | K3_Trialbee Privacy Policy | 1.0 |
| Recruitment arrangements (for publication) | K3_Trialbee_Digital Marketing Content | 1.0 |
| Recruitment arrangements (for publication) | K3_Trialbee_Landing Page | 2.0 |
| Recruitment arrangements (for publication) | K3_Trialbee_Overview Supplementary Information | 1.0 |
| Recruitment arrangements (for publication) | K3_Trialbee_Seconday Assessment And Communication | 2.0 |
| Recruitment arrangements (for publication) | K3_Trialbee_Self Assessment | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_GR_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF DPA | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Genetic Addendum_FRA_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_GPJD Main ICF_FRA_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Clinical Trial Ancillary Supply List | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information materia_Instructions for Use | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Brochure_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Diabetic Ketoacidosis Awareness Guide | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material GI-AE-Brochure | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Hypo Awareness Brochure | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Injection reminder_magnet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material instructions for use | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Participant guide | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material patient card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Study Guide | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Understanding obesity | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_AccuChek Help Screens_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Confidentiality Company Information Notice_GR | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_ConneX Travel Contact Card_GR_Redacted | 10 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_ConneX Travel Reference Guide for Participants_GR_Redacted | 10 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Contact-Card-Participant_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_CT_Care-Partner-Guide_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_CT_GI-AE-Brochure_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_CT-IFU-PFS_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_CWM_Obesity-Infographic_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_CWM_SHOPPING-LIST_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Dexcom Help Screens_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Diabetic-Ketoacidosis-Awareness-Guide_GR | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Emergency Contact Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Hypo-Awareness-Brochure_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Injection-Reminder-Magnet_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Injection-Reminder-MirrorCling_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Letter-Participant-Welcome_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Participant Guide_GR | 4.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient emergency card | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Study-Guide_GR | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Visit Card_GR | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_Privacy Statement | 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 material_ZoomHealth_Terms of service | 1 |
| Subject information and informed consent form (for publication) | L2_Patient emergency card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Study Participant Contact Card_GR | 1 |
| Subject information and informed consent form (for publication) | L3_Subject Instructions for Use_IFU_FRA | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-519685-51-00_GR_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ_2024-519685-51-00_redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ENG_2024-519685-51-00_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2024-519685-51-00_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FRA_2024-519685-51-00_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_RO_2024-519685-51-00_Redacted | b |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-03-05 | Czechia | Acceptable with conditions 2025-06-23
|
2025-06-24 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-31 | Czechia | Acceptable with conditions 2025-06-23
|
2025-07-31 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-22 | Czechia | Acceptable 2026-01-09
|
2026-01-09 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-01-20 | Czechia | Acceptable 2026-01-09
|
2026-01-20 |