Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
974
Countries
5
Sites
39
Hypertension
The GZPL master protocol will support 2 independent studies, J2A-MC-GZL1 (GZL1) and J2A-MC-GZL2 (GZL2). The purpose of this study is to create a framework to evaluate the safety and efficacy of orforglipron for the treatment of hypertension in participants with obesity or overweight.
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Trial duration
- 17 Jul 2025 → ongoing
- Decision date (initial)
- 2025-07-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519000-27-00
- WHO UTN
- U1111-1317-9299
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacokinetic, Efficacy
The GZPL master protocol will support 2 independent studies, J2A-MC-GZL1 (GZL1) and J2A-MC-GZL2 (GZL2). The purpose of this study is to create a framework to evaluate the safety and efficacy of orforglipron for the treatment of hypertension in participants with obesity or overweight.
Conditions and MedDRA coding
Hypertension
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Has systolic blood pressure (SBP) ≥ 140 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg (if DBP criteria alone is met, SBP must be ≥130 mmHg) at screening (visit 1).
- Has SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg (if DBP criteria alone is met, SBP must be ≥130 mmHg) at week 0 (visit 3).
- Untreated for hypertension, or on stable antihypertensive medications ≥ 30 days prior to Visit 1.
- Have a body mass index (BMI) ≥ 25 kg/m²at screening.
Exclusion criteria 6
- Has SBP ≥170 mmHg and/or DBP ≥110 mmHg at Visit 1 or at Visit 3.
- Has known secondary causes of hypertension
- Have heart failure with reduced ejection fraction (HFrEF) diagnosis
- Have had any of the following conditions within 90 days prior to screening. • hospitalization for hypertension or for congestive heart failure • acute coronary syndrome or acute myocardial infarction, or • cerebrovascular accident (stroke).
- Have type 1 diabetes (T1D)
- Have acute or chronic hepatitis, including a history of autoimmune hepatitis
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- (GZPL) Number of Participants Allocated to Each Study [Time Frame: Week -8 to Week 0] (GZL1; GZL2) Change from Baseline in office SBP [Time Frame: Baseline to Week 36]
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
PRD10193651 · Product
- Active substance
- Orforglipron Hemicalcium
- Substance synonyms
- Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 60 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10193655 · Product
- Active substance
- Orforglipron Hemicalcium
- Substance synonyms
- Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 60 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10193663 · Product
- Active substance
- Orforglipron Hemicalcium
- Substance synonyms
- Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 60 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10193667 · Product
- Active substance
- Orforglipron Hemicalcium
- Substance synonyms
- Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 60 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10193674 · Product
- Active substance
- Orforglipron Hemicalcium
- Substance synonyms
- Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 60 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10193676 · Product
- Active substance
- Orforglipron Hemicalcium
- Substance synonyms
- Orforglipron calcium, Calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridin-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}, LY3502970 hemicalcium
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL USE
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 60 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 13
| Organisation | City, country | Duties |
|---|---|---|
| IQVIA Limited ORG-100008655
|
Livingston, United Kingdom | Laboratory analysis |
| Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd. ORG-100043119
|
Shanghai, China | Laboratory analysis |
| Q Squared Solutions (Beijing) Co. Ltd. ORG-100043283
|
Beijing, China | Laboratory analysis |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | Other |
| Q2 Solutions Kk ORG-100050450
|
Koto, Japan | Laboratory analysis |
| Pharmaserve Lilly S.A.C.I. ORG-100005347
|
Kifisia, Greece | On site monitoring, Code 12, Other, Code 2, Code 5 |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
| IQVIA RDS (India) Private Limited ORG-100047036
|
Mumbai, India | Laboratory analysis |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
| Antaros Medical AB ORG-100039055
|
Molndal, Sweden | Other |
Locations
5 EU/EEA countries · 39 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruitment ended | 110 | 9 |
| Germany | Ongoing, recruitment ended | 100 | 9 |
| Greece | Ongoing, recruitment ended | 70 | 6 |
| Poland | Ongoing, recruitment ended | 72 | 8 |
| Spain | Ongoing, recruitment ended | 70 | 7 |
| Rest of world
United States, Japan, India, Argentina, China
|
— | 552 | — |
Investigational sites
CCR Ostrava s.r.o.
N/A, 28. Rijna 3348/65, Moravska Ostrava, Moravska Ostrava A Privoz
Ordinace Rihackovi s.r.o.
N/A, Novodvorska 1029/3, Zebetín, Brno
Clinoxus s.r.o.
N/A, Antala Staska 1670/80, Krc, Prague 4
Diahelp s.r.o.
N/A, Pod Brizkami 897, Zelene Predmesti, Pardubice V
Top Moravia Health s.r.o.
N/A, Vinicni 4049/235, Zidenice, Brno
MU Dr. Šárka Drinková
N/A, Habrecká 450, Ledeč nad Sázavou, Ledeč nad Sázavou
Angiocentrum Komořany
N/A, Do Koutů 2073/ 1a, Praha 4, Praha
Praglandia s.r.o.
N/A, Nadrazni 3368/30a, Smichov, Prague
CTC Hodonin s.r.o.
N/A, Kollarova 4338/9, 695 01, Hodonin
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Universitätsstudienzentrum für Stoffwechselerkrankungen, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Zentrum für klinische Studien Bad Homburg
N/A, Louisenstrasse 63, 61348, Bad Homburg
Zentrum fur klinische Forschung - Köln
N/A, Berliner Strasse 895, 1. OG, Köln
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
N/A, Markt 15, 23758, Oldenburg In Holstein
Hausärztlich-Kardiologisches MVZ am Felsenkeller GmbH/Zentrum für klinische Studien
Zentrum für klinische Studien, Enderstraße 59, Seidnitz-Center, Dresden
Medizentrum Essen Borbeck
N/A, Huelsmannstrasse 6, Borbeck, Essen
Ambenet GmbH Das Ambulante Behandlungsnetz
N/A, Wilhelm-Leuschner-Platz 12, Zentrum-Süd, Leipzig
Familienmedizinisches Zentrum Radowsky
N/A, Luetzner Str. 145, 04179, Leipzig
FutureMeds GmbH
N/A, Wilmersdorfer Strasse 79, Charlottenburg, Berlin
General Hospital Of Athens G Gennimatas
Endocrinology Department, Messogion Avenue 154, 115 27, Athens
Athens Medical Center S.A.
Internal Medicine Clinic, Adersen 1, 115 25, Athens
General Hospital Of Thessloniki G Gennimatas
Internal Medicine Clinic, Ethnikis Aminis 41, 546 35, Thessaloniki
University General Hospital Of Thessaloniki Ahepa
1st Cardiology Clinic, 1st St Kiriakidis Str, 546 36, Thessaloniki
General Hospital Of Thessaloniki Papageorgiou
1st department of Internal Medicine, Ring Road Of Thessaloniki, Ministry Of Pavlos Melas, Efkarpia
University General Hospital Of Ioannina
2nd Department of Internal Medicine, Niarchou Stavrou Avenue, 455 00, Ioannina
Uniwersytecki Szpital Kliniczny W Bialymstoku
Klinika Endokrynologii, Diabetologii i Chorób Wewnętrznych, Ul. Marii Curie-Sklodowskiej 24a, 15-276, Bialystok
Balsammedica Sp. z o.o.
N/A, Ul. Goleszowska 1/U5, 01-249, Warsaw
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.
N/A, Ul. Polskiej Organizacji Wojskowej 12 C, 97-300, Piotrkow Trybunalski
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Oddział Kardiologii, Ul. Monte Cassino 18, 37-700, Przemysl
Regionalna Poradnia Diabetologiczna-Zytkiewicz-Jaruga Stasinska sp.p. Lekarzy
N/A, Ul. Sw. Mikolaja 53/1a, 50-127, Wroclaw
Centrum Medyczne "Hipokrates" Elżbieta i Grzegorz Grześk
N/A, ul. Chopina 11a/2, 85-092, Bydgoszcz
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
N/A, Ul. Krolowej Jadwigi 16, 85-231, Bydgoszcz
Ośrodek Badań Klinicznych "METABOLICA" lek. Robert Witek
N/A, Ul. Najświętszej Marii Panny 9B, 33-100, Tarnów
Equip D'Atencio Primaria Barcelona Sardenya S.L.P.
Primary care, Carrer De Sardenya 466, 08025, Barcelona
Hospital Quironsalud Infanta Luisa
Endocrinology, Calle De San Jacinto 87, 41010, Sevilla
Complexo Hospitalario Universitario A Coruna
Internal medicine, Lugar Jubias De Arriba 84, 15006, A Coruna
Instituto Medico Quirurgico San Rafael S.A.
Soto Gonzalez, Poboado Nucleo Rural La Jubias 82, 15006, A Coruna
Hospital Universitario De Leon
Endocrinology and metabolism, Calle Altos De Nava S/n, 24071, Leon
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
Aliaga Verdugo, Calle Alejo Fernandez 9, 41003, Sevilla
Eap Osona Sud Alt Congost S.L.P.
Primary care, Placa Del Pla Del Mestre 7, 08540, Centelles
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 | 2025-07-21 | 2025-08-05 | 2025-11-20 | ||
| Germany | 2025-08-26 | 2025-08-29 | 2025-11-20 | ||
| Greece | 2025-09-10 | 2025-09-12 | 2025-12-01 | ||
| Poland | 2025-07-31 | 2025-08-07 | 2025-11-20 | ||
| Spain | 2025-07-17 | 2025-07-21 | 2025-11-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 93 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Sub-protocol 2024-519000-27-00 GZL1_Redacted | N/A |
| Protocol (for publication) | D1_ Sub-protocol 2024-519000-27-00 GZL2_Redacted | N/A |
| Protocol (for publication) | D1_GZL1_Protocol_2024-519000-27-00_GR_Redacted | 1 |
| Protocol (for publication) | D1_GZL2_Protocol_2024-519000-27-00_GR_Redacted | 1 |
| Protocol (for publication) | D1_Master Protocol 2024-519000-27-00 GZPL_Redacted | a |
| Protocol (for publication) | D1_Master Protocol a_2024-519000-27-00_Summary of changes_Redacted | a |
| Protocol (for publication) | D1_Protocol_2024-519000-27-00_GR_Redacted | a |
| Protocol (for publication) | D1_Protocol_2024-519000-27-00_GR_Summary of changes_GR_Redacted | a |
| Protocol (for publication) | D4_Patient Documents Copyright | 1.0 |
| Protocol (for publication) | D4_Study Participant Contact Card_GR | 2 |
| Recruitment arrangements (for publication) | 1_Recruitment and Informed consent procedure_GR | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure template | 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_PL | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment materials_Trialbee Global Privacy Policy | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment materials_Trialbee_Digital Marketing Content | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment materials_Trialbee_Landing Page_Redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment materials_Trialbee_Overview Supplementary Information | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment materials_Trialbee_Secondary Assessment And Communication_Redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment materials_Trialbee_Self Assessment_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Trial Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment arrangments_Informed consent and patient recruitment procedure_PL | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Funnelinhalt Lilly_PI Radowsky_Familien-medizinisches Zentrum Radowsky | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material Vorlage-FB_INSTAGRAM_PI Radowsky_Familien-medizinisches Zentrum Radowsky | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_GR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_GR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter doctor referral | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter Doctor Referral | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_GR | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_text emovis GmbH | 1.3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trial Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Flyer | 1 |
| Recruitment arrangements (for publication) | K3_Other subject information material_Flyer_Master_PL | 1 |
| Recruitment arrangements (for publication) | K3_Other subject information material_Poster_Master_PL | 1 |
| Recruitment arrangements (for publication) | K3_Other subject information material_Trial-Brochure_PL | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment digital campaign_Trialbee_Digital Marketing Content | 1.0 |
| Recruitment arrangements (for publication) | K3_Recruitment digital campaign_Trialbee_Global Privacy Policy | 1.0 |
| Recruitment arrangements (for publication) | K3_Recruitment digital campaign_Trialbee_Landing Page_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K3_Recruitment digital campaign_Trialbee_Overview Supplementary Information | 1.0 |
| Recruitment arrangements (for publication) | K3_Recruitment digital campaign_Trialbee_Secondary Assessment And Communication_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K3_Recruitment digital campaign_Trialbee_Self Assessment_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main_GR_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Data Privacy Addendum | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted_PL | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Compensation Information Sheet_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Compensation information sheet_Redacted | 1.0 |
| 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_Letter Participant Welcome_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Information Card | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Study Guide_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Study Guide_GR_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Participant Contact Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Thank You End Of Study_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Thank You Participation_GR | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information Material_Visit Card_GR | 2 |
| 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 material_ZoomHealth_TermsofService | 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_Study Guide_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Trial Brochure | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Visit Card | 2.0 |
| Subject information and informed consent form (for publication) | L2_Patient cards | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Documents Not submitted_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Study Participant Contact Card_GR | 2 |
| Subject information and informed consent form (for publication) | L3_Info Re insurance Conditions for Patient_PL | 1 |
| Synopsis of the protocol (for publication) | D1_ Master protocol synopsis GZPL_ES_2024-519000-27-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_GZL1 Protocol synopsis_ENG_2024-519000-27-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_GZL1_Protocol Synopsis_2024-519000-27-00_GR_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_GZL2 Protocol synopsis_ENG_2024-519000-27-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_GZL2_Protocol Synopsis_2024-519000-27-00_GR_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_GZPL Protocol synopsis_ENG_2024-519000-27-00_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-519000-27-00_GR_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL 2024-519000-27-00_GZL1_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL 2024-519000-27-00_GZL2_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL 2024-519000-27-00_GZPL_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Sub protocol synopsis GZL1_ES_2024-519000-27-00_Redacted | initial |
| Synopsis of the protocol (for publication) | D1_Sub protocol synopsis GZL2_ES_2024-519000-27-00_Redacted | initial |
| Synopsis of the protocol (for publication) | D4_Protocol Synopsis_GZL1_CZE_2024-519000-27-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D4_Protocol Synopsis_GZL2_CZE_2024-519000-27-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D4_Protocol Synopsis_GZPL_CZE_2024-519000-27-00_Redacted | a |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-04-01 | Germany | Acceptable with conditions 2025-07-01
|
2025-07-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-24 | Germany | Acceptable with conditions | 2025-08-26 |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-01 | Germany | Acceptable with conditions | 2025-11-06 |
| 4 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-10-03 | Acceptable with conditions | 2025-12-01 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-12-19 | Germany | Acceptable 2026-02-19
|
2026-02-20 |
| 6 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-03-02 | Germany | Acceptable 2026-02-19
|
2026-03-02 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-02 | Acceptable 2026-02-19
|
2026-03-02 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-03-16 | Germany | Acceptable | 2026-05-15 |