Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
2,300
Countries
4
Sites
36
Obesity
The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1)
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
- 10 Oct 2023 → 30 Apr 2026
- Decision date (initial)
- 2023-09-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503657-35-00
- WHO UTN
- U1111-1287-2294
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Efficacy
The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1)
Conditions and MedDRA coding
Obesity
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
- Be overweight
- Have history of unsuccessful dietary weight loss effort
- (GOA1) Have index knee pain for >12 weeks prior to screening and at least one of the following (GOA1) Age >50 years (GOA1) Morning stiffness in the index knee less than 30 minutes in duration (GOA1) Crepitus in the index knee
Exclusion criteria 3
- Have a self-reported or documented change in body weight > 5kg within 90 days prior to screening
- (GOA1) Pain from another location with radiation to the knee (for example, hip pain referred to the knee, radicular pain)
- (GOA1) Knee infection
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Percent Change from Baseline in Body Weight
- Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score for GOA1 Subset
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
PRD10345209 · Product
- Active substance
- LY3437943 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10345508 · Product
- Active substance
- LY3437943 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10345188 · Product
- Active substance
- LY3437943 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10345551 · Product
- Active substance
- LY3437943 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD10345489 · Product
- Active substance
- LY3437943 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 0 mg milligram(s)
- Max treatment duration
- 1 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 12
| Organisation | City, country | Duties |
|---|---|---|
| Brightech International, LLC ORL-000001293
|
Somerset, NJ, United States | Code 10 |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
| Q2 Solutions BioSciences ORL-000001587
|
Ithaca NY, United States | Laboratory analysis |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| IQVIA RDS (India) Private Limited ORG-100047036
|
Mumbai, India | Laboratory analysis |
| Yprime LLC ORG-100042888
|
Malvern, United States | E-data capture |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| Clario ORL-000001584
|
San Mateo CA, United States | Laboratory analysis |
| Pharmaceutical Product Development, LLC (PPD) ORL-000001586
|
Zavenstem, Belgium | Laboratory analysis |
| Techdata Service Company LLC ORG-100047422
|
Kng Of Prussa, United States | Code 10 |
| RWS Life Sciences, Inc. ORL-000001588
|
Hartford, CT, United States | Other |
Locations
4 EU/EEA countries · 36 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ended | 136 | 8 |
| Poland | Ended | 170 | 12 |
| Romania | Ended | 109 | 10 |
| Spain | Ended | 25 | 6 |
| Rest of world
Canada, India, China, United States, Brazil, Korea, Republic of, Taiwan, Australia, United Kingdom, Mexico
|
— | 1,860 | — |
Investigational sites
University Of Debrecen
N/A, Bartok Bela Ut 2-26, 4031, Debrecen
Medifarma-98 Kft.
N/A, Praga Utca 9, 4400, Nyiregyhaza
Clindiab Kft.
N/A, Szakolcai Utca 8/XVIII, XVIII Kerulet, Budapest XVIII
DRC Kft.
N/A, Ady Endre Utca 12/b, 8230, Balatonfured
University Of Debrecen
N/A, Nagyerdei Korut 98, 4032, Debrecen
University Of Szeged
N/A, Kalvaria Sugarut 57, 6725, Szeged
Regia Med Kft.
N/A, Bregyo Koz 5, 8000, Szekesfehervar
Obudai Egeszsegugyi Centrum Kft.
N/A, Lajos Utca 74-76, 1036, Budapest III
Samodzielny Publiczny Zakład Opieki Zdrowotnej Opolskie Centrum Onkologii im. prof. Tadeusza Koszar
Ośrodek Badań Klinicznych "METABOLICA" Lek. Robert Witek, Najświętszej Marii Panny 9B,, 33-100, Małopolskie, Tarnów
Uniwersytecki Szpital Kliniczny W Bialymstoku
Uniwersytecki Szpital Kliniczny w Bialymstoku (Klinika Endokrynologii), LOC-100074827: Ul. Marii Curie-Sklodowskiej 24a,, 15-276, Bialystok
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.
Centrum Kliniczno-Badawcze, Ul. Studzienna 35-36/a, 82-300, Elblag
Terpa Sp. z o.o. S.K.
Gabinety TERPA, Ul. Pogodna 34, 20-337, Lublin
Centrum Zdrowia Metabolicznego Pawel Bogdanski
Centrum Zdrowia Metabolicznego Pawel Bogdanski, ul. Nowina 14F, 60-589, Poznan
Salvia Lekston I Madej Sp. J.
NZOZ Salvia CM, Ul. Panewnicka 201/1, 40-772, Katowice
Ambulatorium Sp. z o.o.
Ambulatorium Sp. z o.o, Ul. Topolowa 28, 82-300, Elblag
Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otylosci
Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otylosci, Ulica Zagórska 10/5, Świętokrzyskie, Kielce
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Centrum badan Klinicznych PI-House sp. z o.o, Ul. Na Zaspe 3, 80-546, Gdansk
Centermed Sp. z o.o.
Centermed Sp. z o.o., Ul. Weteranow 46, 20-044, Lublin
Centrum Medyczne Intercor Sp. z o.o.
Intercor, Ul. Kasztanowa 57, 85-605, Bydgoszcz
Medicover Integrated Clinical Services Sp. z o.o.
Medicover Integrated Clinical Services Sp. z o.o., Ul. Chlodna 52, 00-872, Warsaw
Diamed Obesity S.R.L.
Societatea Diamed Obesity SRL, Gheorghe Doja Nr 73, 800291, Galati
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
C.M.D.T.A Neomed, Strada Crisului Nr. 1, 500283, Brasov
Diabdana S.R.L.
Diabdana SRL, Calea Republicii Nr 77, 410147, Oradea
Cabinet Medical Dr Geru S.R.L.
Cabinet Medical Dr.Geru, Aleea Lirei Nr 1, Ap. 2, Timisoara
Minimed S.R.L.
Diabetes, Strada Pacii Nr.7, 600274, Bacau
Gama Diamed S.R.L.
SC Gama Diamed SRL, T S Saveanu Nr 1, 905500, Mangalia
Policlinica Astra Sibiu
Policlinica Astra Sibiu, Strada Grigore Alexandrescu, Nr. 1, Sibiu
Clinica Korall S.R.L.
Clinica Korall, P-Ta Eroii Revolutiei, Corp A Apartament M-2 Nr 22, Satu Mare
Hightech Medical Services SRL
Hightech Medical Services SRL, Bulevardul Alexandru Ioan Cuza nr. 76, 11057, București
Consultmed S.R.L.
SC Consultmed SRL, Block 550, Soseaua Pacurari 70, Jassi
Area Sanitaria De Ferrol
Área Sanitaria De Ferrol, Avenida Residencia S/n, 15405, Ferrol
Complexo Hospitalario Universitario A Coruna
Complexo Hospitalario Universitario A Coruña, Lugar Jubias De Arriba 84, 15006, A Coruna
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional, Calle Alejo Fernandez 9, 41003, Sevilla
Hospital General Universitario De Valencia
Hospital General Universitario De Valencia, Avenida Del Tres Cruces S/n, 46014, Valencia
Hospital Universitari Vall D Hebron
Hospital Universitari Vall D Hebron, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Marques De Valdecilla
Hospital Universitario Marqués de Valdecilla, 5 Planta, Avenida Valdecilla S/n, Santander
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 |
|---|---|---|---|---|---|
| Hungary | 2023-10-11 | 2025-09-23 | 2023-10-16 | 2024-05-28 | |
| Poland | 2023-10-12 | 2026-04-09 | 2023-10-17 | 2024-08-01 | |
| Romania | 2023-10-11 | 2026-01-23 | 2023-10-11 | 2024-05-28 | |
| Spain | 2023-10-10 | 2025-11-11 | 2023-10-17 | 2024-08-01 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 178 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Master protocol 2023-503657-35-00 GZBJ_Redacted | e |
| Protocol (for publication) | D1_Sub protocol 2023-503657-35-00 GOA1_Redacted | a |
| Protocol (for publication) | D4_Patient facing documents_copyright | 1.0 |
| Recruitment arrangements (for publication) | GOA1_Patient_Messaging_Master_PL | 1 |
| Recruitment arrangements (for publication) | GOA1_Website_Copy_Master_PL | 1 |
| Recruitment arrangements (for publication) | GZBJ_Patient_Messaging_Master_PL | 1 |
| Recruitment arrangements (for publication) | GZBJ_Website_Copy_Master_PL | 1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_GOA1 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_GOA1_English | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_GOA1_PL | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_GZBJ | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_GZBJ_English | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_GZBJ_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Spanish | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Chronic_Weight_Social_Media_Video_Master_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Digital_Ads_Comorbidities_Master_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Digital_Ads_General_Chronic_Weight_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Digital_Ads_General_Chronic_Weight_Master_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Master_CC_WS_Script_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Master_CC_WS_Script_Master_PL | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_OA_Social_Media_Video_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_OA_Social_Media_Video_Master_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Obesity_and_Establish_CVD_Social_Media_Video_Master_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Obesity_Social_Media_Video_Master_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Program_Database_Messaging_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Program_Database_Messaging_Master_PL | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Program_Social_Media_Video_Master_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Program_Website_Copy_Master_PL | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Program_Website_Policies_Master_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Screener_Edition 2_Master_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Search_Ads_Master_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_SHOPPING-LIST_MASTER_V1_30JAN2023_RO (Romania) | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_Spanish | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Flyer | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_POSTER | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_POSTER_MASTER_V1_20APR2023_RO(Romania) | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_Spanish | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_TRIAL BROCHURE DG_MASTER_V1_20APR2023_RO(Romania) | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_TRIAL-BROCHURE | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_TRIAL-BROCHURE_MASTER_V1_20APR2023_RO(Romania) | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_TRIAL-BROCHURE-DG | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_CWM_Chronic_Weight_Social_Media_Video_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_CWM_Digital_Ads_Comorbidities_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_CWM_Digital_Ads_Comorbidities_Master_V1_28Aug2023 | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_CWM_Digital_Ads_General_Chronic_Weight_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_CWM_Obesity_and_Establish_CVD_Social_Media_Video_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_CWM_Obesity_Social_Media_Video_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_CWM_Program_Database_Messaging_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_CWM_Program_Social_Media_Video_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_CWM_Program_Website_Copy_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_CWM_Program_Website_Policies_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_CWM_Program_Website_Policies_Master_V1_28Aug2023 | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_CWM_Screener_Edition 2_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_CWM_Screener_Edition 2_Master_V1_28Aug2023 | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_CWM_Search_Ads_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment materials_GOA1_Patient_Messaging_Master | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitmet materials_GOA1_Website_Copy_Master | 1.0 |
| Recruitment arrangements (for publication) | K3_List of planned sites Poland | 3 |
| Recruitment arrangements (for publication) | K3_List of planned sites Poland_TC | 1 |
| Recruitment arrangements (for publication) | K4_Informed consent and patient recruitment procedure | 2 |
| Recruitment arrangements (for publication) | K4_Informed consent and patient recruitment procedure_TC | 2 |
| Recruitment arrangements (for publication) | L2_Other subject information_getting back in the game after significant weight loss_PL | 1 |
| Recruitment arrangements (for publication) | L2_Other subject information_losing weight and re-entering the social scene_PL | 1 |
| Recruitment arrangements (for publication) | L2_Other subject information_why is it so difficult to lose weight_PL | 1 |
| Subject information and informed consent form (for publication) | L1_Greenphire ICF | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Main_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ICF Summary of Changes_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic_Redacted | 1.1 |
| 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 SoC_PL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF GOA1_Spanish_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF_PL_GOA1_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Greenphire addendum ICF_Spanish | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF GZBJ_Spanish_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_SoC_24Jan2025_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Main ICF_GZBJ_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Main_GZBJ_TC_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of changes_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_GGG_CARE-PARTER-GUIDE_MASTER_V1_18APR2023_RO | 1 |
| Subject information and informed consent form (for publication) | L2_GGG_GI-AE Reference card_V3_20JUN2023_RO | 3.0 |
| Subject information and informed consent form (for publication) | L2_GGG_Hypoglycemia brochure_V2_21MAR2023_RO | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other information given to patients_Spanish_Spain_ConneX Spain Travel Contact Card | 2 |
| Subject information and informed consent form (for publication) | L2_Other information given to patients_Spanish_Spain_ConneX Spain Travel Ref Guide for Subjects | 2 |
| Subject information and informed consent form (for publication) | L2_Other information given to patients_Spanish_Spain_Greenphire ClinCard Msg Templates | 6 |
| Subject information and informed consent form (for publication) | L2_Other information given to patients_Spanish_Spain_Greenphire EU Generic ClinCard | 3 |
| Subject information and informed consent form (for publication) | L2_Other information given to patients_Spanish_Spain_Greenphire_ClinCard_Card_Carrier_EU | 3 |
| Subject information and informed consent form (for publication) | L2_Other information given to patients_Spanish_Spain_Greenphire_ClinCard_Cardholder_FAQ_EU | 3 |
| Subject information and informed consent form (for publication) | L2_Other information given to patients_Spanish_Spain_Greenphire_Fee_Schedule | 4 |
| Subject information and informed consent form (for publication) | L2_Other information material_EC_packet_w_Data_Privacy_as_applied_to_GP | 9 |
| Subject information and informed consent form (for publication) | L2_Other information material_Greenphire ClinCard Msg Templates-ROW | 6 |
| Subject information and informed consent form (for publication) | L2_Other information material_Greenphire_ClinCard_Card_Carrier_EU | 3 |
| Subject information and informed consent form (for publication) | L2_Other information material_Greenphire_ClinCard_Cardholder_FAQ_EU | 3 |
| Subject information and informed consent form (for publication) | L2_Other information material_Greenphire_Fee_Schedule | 4 |
| Subject information and informed consent form (for publication) | L2_Other information material_Template-Greenphire EU Generic ClinCard | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Emergency Card GOA1 - Poland | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Emergency Card GZBJ - Poland | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appreciation Items | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Care Partner Guide | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Getting back in the game after significant weightloss | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_GI-AE Reference Card | 3.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Hypoglycaemia Brochure | 2.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Losing weight and re-entering the social scene | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Participant Welcome Letter | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Shopping List | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Study Guide | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Thank You_Participation | 1.2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Thank You_Screening | 1.2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Visit Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Why is it so difficult to lose weight | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_LETTER-PARTICIPANT-WELCOME_GOA1 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_THANK-YOU-PARTICIPATION_MASTER_GOA1 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_VISIT-CARD_MASTER_GOA1 | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_VISIT-CARD_MASTER_GZBJ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_CARE-PARTER-GUIDE_MASTER | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_CARE-PARTER-GUIDE_MASTER_Print | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_CARE-PARTER-GUIDE_POLAND | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_CARE-PARTER-GUIDE_POLAND_Print | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_getting back in the game after significant weight loss_RO | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_GI-AE-REFERENCE-CARD | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information_GI-AE-REFERENCE-CARD_Print | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information_GOA1_STUDY-GUIDE_MASTER | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_GOA1_STUDY-GUIDE_MASTER_Print | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_GOA1_STUDY-GUIDE-DG_MASTER | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_GOA1_STUDY-GUIDE-DG_MASTER_Print | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_GZBJ_GOA1_SCHEDULE-OF-ACTIVITIES_MASTER | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_GZBJ_STUDY-GUIDE_MASTER | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_GZBJ_STUDY-GUIDE_MASTER_Print | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_GZBJ_STUDY-GUIDE-DG_MASTER | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_GZBJ_STUDY-GUIDE-DG_MASTER_Print | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_HYPOGLYCAEMIA-AWARENESS-BROCHURE | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information_HYPOGLYCAEMIA-AWARENESS-BROCHURE_Print | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information_losing weight and re-entering the social scene_RO | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_why is it so difficult to lose weight_RO | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject informGZBJ_GOA1_SCHEDULE-OF-ACTIVITIES_MASTER_Print | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Facing documentation | 1 |
| Subject information and informed consent form (for publication) | L2_STUDY-GUIDE_MASTER_V1_26JUN2023_RO | 1 |
| Subject information and informed consent form (for publication) | L2_Thank You Card_Dropout | 3 |
| Subject information and informed consent form (for publication) | L2_Thank You Card_End of Study | 3 |
| Subject information and informed consent form (for publication) | L2_Thank You Card_Participation | 3 |
| Subject information and informed consent form (for publication) | L2_Thank You Card_Screening | 3 |
| Subject information and informed consent form (for publication) | L3_ Greenphire EU Generic ClinCard (v3.0 April 2019) | 3 |
| Subject information and informed consent form (for publication) | L3_Appreciation Items List_GOA1 | 1 |
| Subject information and informed consent form (for publication) | L3_Appreciation Items List_GZBJ | 2 |
| Subject information and informed consent form (for publication) | L3_Greenphire ClinCard Msg Templates - ROW (v6.0 Feb 2018) | 3 |
| Subject information and informed consent form (for publication) | L3_Greenphire_ClinCard_Card_Carrier_EU_V3.0 | 3 |
| Subject information and informed consent form (for publication) | L3_Greenphire_ClinCard_Cardholder_FAQ_EU_V3.0 | 3 |
| Subject information and informed consent form (for publication) | L3_Greenphire_Fee_Schedule_V4.0 | 4 |
| Subject information and informed consent form (for publication) | L3_Greephire_EC_packet_w_Data_Privacy_as_applied_to_GP_v7.0 | 7 |
| Subject information and informed consent form (for publication) | L3_Other patient material_Ancillary Items List | 2 |
| Subject information and informed consent form (for publication) | L3_Other patient material_Study Participant Contact Card - Romania | 2 |
| Subject information and informed consent form (for publication) | L3_Reimbursement_Greenphire_ClinCard Sample | 1 |
| Subject information and informed consent form (for publication) | L3_Reimbursement_Greenphire_EC Submission Overview Hungary | 1 |
| Subject information and informed consent form (for publication) | L3_Reimbursement_HU_Greenphire_ClinCard Carrier | 1 |
| Subject information and informed consent form (for publication) | L3_Reimbursement_HU_Greenphire_ClinCard FAQ | 1 |
| Subject information and informed consent form (for publication) | L3_Reimbursement_HU_Greenphire_ClinCard Msg Templates | 1 |
| Subject information and informed consent form (for publication) | L3_Reimbursement_HU_Greenphire_Fee Schedule | 1 |
| Subject information and informed consent form (for publication) | L3_RETATRUTIDE Instructions for use | 1 |
| Subject information and informed consent form (for publication) | L4_Annex 3_Recruitment and consenting procedure | 1 |
| Subject information and informed consent form (for publication) | L4_Annex 7_Financial compensation for patients | 1 |
| Subject information and informed consent form (for publication) | L4_Patient Card | 1 |
| Subject information and informed consent form (for publication) | L5_Directions for Use_HU | 1 |
| Subject information and informed consent form (for publication) | L5_Info Re insurance Conditions for Patient | 1 |
| Subject information and informed consent form (for publication) | Patient information card_Spanish | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2023-503657-35-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis EN 2023-503657-35-00_GOA1_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis PL_2023-503657-35-00_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-503657-35-00_PL_GOA1_Redacted | a |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-503657-35-00_PL_GOA1_TC_Redacted | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-503657-35-00_PL_GZBJ_TC_Redacted | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_HU 2023-503657-35_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_RO_2023-503657-35_Redacted | e |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SP_2023-503657-35-00_GOA1_Redacted | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SP_2023-503657-35-00_GZBJ_Redacted | 3.0 |
Application history
10 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-06 | Hungary | Acceptable 2023-09-25
|
2023-09-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-15 | Hungary | Acceptable 2024-02-26
|
2024-02-28 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-04-09 | Hungary | Acceptable 2024-02-26
|
2024-04-09 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-04-24 | Acceptable | 2024-06-10 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-04-24 | Hungary | Acceptable | 2024-05-31 |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-30 | Acceptable | 2024-06-10 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-04-30 | Acceptable | 2024-07-22 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-10-01 | Hungary | Acceptable 2024-11-14
|
2024-11-18 |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-03-20 | Hungary | Acceptable 2025-05-12
|
2025-05-16 |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-08-12 | Acceptable | 2025-10-07 |