Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
150
Countries
3
Sites
12
Obesity
The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity or overweight with at least one weight-related comorbidity.
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 7 Dec 2023 → ongoing
- Decision date (initial)
- 2023-11-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-504413-80-00
- WHO UTN
- U1111-1290-7549
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Pharmacodynamic, Efficacy, Safety
The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity or overweight with at least one weight-related comorbidity.
Conditions and MedDRA coding
Obesity
Regulatory references
- EMA paediatric investigation plan (PIP)
- EMEA-002360-PIP02-22
- Plan to share IPD
- Yes
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Have been diagnosed with obesity OR overweight with at least 1 weight-related comorbidity (abnormal lipids, high blood pressure, fatty liver disease, sleep apnea, prediabetes or type 2 diabetes).
- Have not been able to lose weight with healthy diet and physical activity
- If with Type 2 diabetes mellitus have been treated with either diet and exercise alone or with metformin for at least 90 days prior to screening and have a HbA1c <9.0%
Exclusion criteria 6
- Have lost more than 5 kg in the 90 days before screening.
- Have Type 1 Diabetes.
- Have not started puberty.
- Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome Type 2
- Have a history of pancreatitis.
- Have had or plan to have a weight loss surgery during the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percent Change from Baseline in Body Mass Index
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
PRD11922457 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 17 Month(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
- SOLUTION FOR INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 17 Month(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
- SOLUTION FOR INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 17 Month(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
- SOLUTION FOR INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 17 Month(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
- SOLUTION FOR INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 17 Month(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
- SOLUTION FOR INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 17 Month(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
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 17 Month(s)
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- 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 10
| Organisation | City, country | Duties |
|---|---|---|
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Laboratory analysis |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Jumo Health USA Inc. ORG-100044054
|
New Haven, United States | Other |
| Virtualscopics LLC ORL-000002233
|
Rochester, NY, United States | Laboratory analysis |
| IQVIA RDS (India) Private Limited ORG-100047036
|
Mumbai, India | Laboratory analysis |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
| Brightech International, LLC ORL-000001391
|
Somerset, NJ, United States | Code 10 |
Locations
3 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruitment ended | 9 | 5 |
| Italy | Ongoing, recruitment ended | 11 | 4 |
| Poland | Ongoing, recruitment ended | 17 | 3 |
| Rest of world
Israel, Mexico, United States, Canada
|
— | 113 | — |
Investigational sites
Fakultni Nemocnice Kralovske Vinohrady
Klinika deti a dorostu, Srobarova 1150/50, Vinohrady, Prague 10
Nemocnice AGEL Ostrava-Vitkovice a.s.
Detske oddeleni, Zaluzanskeho 1192/15, Vitkovice, Ostrava
Nemocnice Jihlava prispevkova organizace
Pediatricke oddeleni, Vrchlickeho 4630/59, 586 01, Jihlava 1
Fakultni Nemocnice V Motole
Pediatrické oddělení, V Uvalu 84/1, Motol, Prague
ReFit Clinic s.r.o.
N/A, U Realky 1076/4, 779 00, Olomouc
Universita' Degli Studi Di Verona
Pediatria B, Piazzale Aristide Stefani 1, 37126, Verona
Azienda Unita Sanitaria Locale Di Bologna
U.O. Pediatria Pession, Via Giuseppe Massarenti 9, 40138, Bologna
Universita' Degli Studi Di Messina
DAI Materno Infantile, Via Consolare Valeria 1, 98125, Messina
Azienda Ospedaliero-Universitaria Maggiore Della Carita
SCDU Pediatria, Corso Giuseppe Mazzini 18, 28100, Novara
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
Oddzial Endokrynologii Dzieci, Ul. 3 Maja 13/15, 41-800, Zabrze
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Poradnia Diabetologiczna, Ul Sporna 36/50, 91-738, Lodz
Instytut Diabetologii Sp. z o.o.
Pańkowska, Ul. Raclawicka 129/2u, 02-117, Warsaw
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 | 2023-12-07 | 2024-01-22 | 2024-12-20 | ||
| Italy | 2023-12-15 | 2024-03-26 | 2024-12-20 | ||
| Poland | 2023-12-07 | 2024-01-08 | 2024-12-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 139 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-504413-80-00_Redacted | f |
| Protocol (for publication) | D4_Patient facing documents_copyright | 1.0 |
| Recruitment arrangements (for publication) | GPHP_Waiver of the right to appeal_CL_29Nov2023_redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_Aldhoon Hainerova | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_Bozensky | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_Krenek Malikova | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_Pastucha | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_Vlachy | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_IT | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_IT_TC | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Appointment Reminder Card_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Completion Certificate_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_List of planned Sites and Subjects_IT_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_List of planned sites_CZ_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Letter_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Letter_Master_CZ | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Patient Letter_Master_IT_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Poster_Master_CZ | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment Poster_Master_IT_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Letter_Master_CZ_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Referral Letter_Master_IT_Redacted | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Schedule Passport Interactive_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Schedule Planner_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_School Note_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Site Reference Cards | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Site Reference Cards_CZ | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trifold_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trifold_Master_CZ | 2 |
| Recruitment arrangements (for publication) | K3_List of planned sites Poland | NA |
| Subject information and informed consent form (for publication) | ICF Summary of Changes_Adult_Redacted | 1 |
| Subject information and informed consent form (for publication) | ICF Summary of Changes_Parent_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Abbreviated 18 and over | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Abbreviated 18 and over_TC | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent 12-17 older child_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent 12-17 older child_TC_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Main_Older child_12-17 yr_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Main_Older child_12-17 yr_TC_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Prescreening_Older child_12-17 yr | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Assent Prescreening_Older child_12-17 yr_TC | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main 18 and over_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main 18 and over_TC_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_adults_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_parents_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening Assent 12-17 | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening Assent 12-17_TC | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening_parents | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening_parents_clean_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Prescreening_parents_TC_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF SoC_PL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF Optional Activity_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Study Partner_Clean | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 12-14_optional OLE extension_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 15-17_optional OLE extension_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent Form_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DPA_Adult | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DPA_Parent | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Parent_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Adult_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Adult_Summary of changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Assent_12-14_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Assent_15-17_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Parent | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Assent Form_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Study Participant_ICF_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Study Partner_ICF_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening Addendum_Adult | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening Addendum_Adult_TC | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening Addendum_Assent_12-14 | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Prescreening Addendum_Assent_15-17years | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Reimbursement_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Study Participant_optional OLE extension_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Study Partner_DPA_optional OLE extension_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Study Partner_optional OLE extension_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_ Glucometer MDR_EU_Certificate_G10 092547 0018 Rev_2 | NA |
| Subject information and informed consent form (for publication) | L2_EC Glucometer Certifcate _ Roche supplies | NA |
| Subject information and informed consent form (for publication) | L2_Glucometer Accu-Chek Instant EC Conformity | NA |
| Subject information and informed consent form (for publication) | L2_Glucometer Accu-Chek Softclix EC Conformity | NA |
| Subject information and informed consent form (for publication) | L2_Glucometer IVDR_Certificate_V10 092547 0022 Rev_ 00_QMS | NA |
| Subject information and informed consent form (for publication) | L2_Lettera al Medico Curante_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Facing Material CT IFU | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information Insurance Conditions for Patient | 2 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information material Clinical Trial Ancillary Supply List_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material__EC_packet_w_Data_Privacy_as_applied_to_GP | 9 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_AccuCheck Instruction of use | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Cogstate | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Msg Templates - ROW | 6 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire EU Generic ClinCard | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_ClinCard_Card_Carrier_EU | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_ClinCard_Cardholder_FAQ_EU | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_Fee_Schedule | 4 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_How To Self Inject | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Schedule Passport Interactive_Redacted | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Test Supervisor Script Cogstate | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Tirzepatide MOA | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Understanding Study | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Appointment Reminder Card_Master_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Clinical Trial Ancillary Supply List_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Completion Certificate_Master_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Country Patient Information Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Cover Letter Visual Acuity and Fundoscopic Exam_IT | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Schedule Passport Interactive_Master_CZ | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Schedule Planner_Master_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_School Note_Master_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Thank You Card_Master_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_TIRZEPATIDE IFU_IT | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Visual Acuity and Fundoscopic Exam Results_IT | 1 |
| Subject information and informed consent form (for publication) | L2_Retention material_Appointment Reminder Card_Master_IT_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Retention material_Completion Certificate_Master_IT_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Retention Material_Schedule Passport Interactive_Master_IT_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Retention Material_Schedule Planner_Master_IT_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Retention Material_School Note_Master_IT_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Retention Material_Site Reference Cards_IT_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Retention Material_Thank You Card_Master_IT_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Retention Material_Trifold_Master_IT_Redacted | 2 |
| Subject information and informed consent form (for publication) | L3_Other subject information Contact Card for Study Participants | NA |
| Subject information and informed consent form (for publication) | L4_Appreciation Items OUS Form | 1 |
| Subject information and informed consent form (for publication) | L4_Informed consent and patient recruitment procedure | 1 |
| Subject information and informed consent form (for publication) | L4_Other subject information for Cover letter for Participants Fundoscopic Exam | 1 |
| Subject information and informed consent form (for publication) | L4_Other subject information for Participants Fundoscopic Exam Results | 1 |
| Subject information and informed consent form (for publication) | L5_Cogstate Test Scripts_CZ | 1 |
| Subject information and informed consent form (for publication) | L6_Cover Letter Visual Acuity and Fundoscopic Exam_WS_Paper | 1.0 |
| Subject information and informed consent form (for publication) | L6_TIRZEPATIDE IFU_v1_WS_Paper | 1.0 |
| Subject information and informed consent form (for publication) | L6_Visual Acuity and Fundoscopic Exam Results_WS_Paper | 1.0 |
| Subject information and informed consent form (for publication) | L7_Czech_Greenphire Travel Contact Card | 2.0 |
| Subject information and informed consent form (for publication) | L7_EC_packet_w_Data_Laws_as_applied_to_GP | 6.0 |
| Subject information and informed consent form (for publication) | L7_General_ConneX_EC_packet_w_Data_Privacy_as_applied_to_GP | 2.0 |
| Subject information and informed consent form (for publication) | L7_Greenphire ClinCard Msg Templates_ROW | 6.0 |
| Subject information and informed consent form (for publication) | L7_Greenphire ClinCard Travel Ref Guide for Subjects | 3.0 |
| Subject information and informed consent form (for publication) | L7_Greenphire_ClinCard_Card_Carrier | 1.0 |
| Subject information and informed consent form (for publication) | L7_Greenphire_ClinCard_Cardholder_FAQ_EU | 3.0 |
| Subject information and informed consent form (for publication) | L7_Greenphire_Fee_Schedule | 4.0 |
| Subject information and informed consent form (for publication) | L7_Template_Greenphire EU Generic ClinCard | 3.0 |
| Subject information and informed consent form (for publication) | L8_Study Participant Emergency Contact Card | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ_2023-504413-80-00_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EN_2023-504413-80_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ITA_2023-504413-80-00_Redacted | f |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL 2023-504413-80-00_Redacted | f |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-08-03 | Italy | Acceptable 2023-11-27
|
2023-11-27 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-11-29 | Acceptable 2023-11-27
|
2023-11-29 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-14 | Acceptable | 2024-02-09 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-17 | Italy | Acceptable 2024-08-26
|
2024-08-26 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-04-23 | Italy | Acceptable 2025-07-14
|
2025-07-16 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-31 | Italy | Acceptable 2025-07-14
|
2025-07-31 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-08-28 | Italy | Acceptable 2025-10-20
|
2025-10-20 |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-11-20 | Italy | Acceptable 2025-10-20
|
2025-11-20 |
| 9 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-11-24 | Acceptable | 2025-12-22 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-11-25 | Acceptable | 2026-01-20 |