Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
1,800
Countries
4
Sites
45
Obesity
The main purpose of this study is to evaluate the efficacy and safety of retatrutide once weekly in participants with obesity and established cardiovascular disease (CVD).
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
- 5 Sep 2023 → 26 May 2026
- Decision date (initial)
- 2023-08-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-503659-88-00
- WHO UTN
- U1111-1287-3354
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
The main purpose of this study is to evaluate the efficacy and safety of retatrutide once weekly in participants with obesity and established cardiovascular disease (CVD).
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
- Have obesity.
- Have established heart disease.
- Have history of unsuccessful dietary weight loss effort
Exclusion criteria 7
- have had the following within 90 days before screening: heart attack, stroke, a procedure to get blood flowing back into the heart, or been hospitalized for either congestive heart failure or sudden chest pain because of a blood clot in the heart
- Have been taking weight loss drugs, including over-the-counter medications, within 90 days before screening
- Have a self-reported change in body weight greater than 11 pounds within 90 days before screening.
- have undergone weight loss surgery (e.g. stomach stapling, lap banding) within 1 year before screening
- Have Type 1 diabetes
- Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- Have had chronic or acute pancreatitis
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percent Change from Baseline in Body Weight
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
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
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
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 |
|---|---|---|
| IQVIA RDS (India) Private Limited ORG-100047036
|
Mumbai, India | Laboratory analysis |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring |
| Biotel Research LLC ORG-100039864
|
Rochester, United States | Laboratory analysis |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| Brightech International, LLC ORL-000001293
|
Somerset, NJ, United States | Code 10 |
| Yprime LLC ORG-100042888
|
Malvern, United States | E-data capture |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| PPD Global Central Labs ORG-100046496
|
Zaventem, Belgium | Laboratory analysis |
| Techdata Service Company LLC ORG-100047422
|
Kng Of Prussa, United States | Code 10 |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
Locations
4 EU/EEA countries · 45 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Hungary | Ended | 87 | 12 |
| Poland | Ended | 117 | 10 |
| Slovakia | Ended | 81 | 9 |
| Spain | Ended | 104 | 14 |
| Rest of world
Argentina, Australia, Mexico, Canada, United States
|
— | 1,411 | — |
Investigational sites
DRC Kft.
N/A, Ady Endre Utca 12/b, 8230, Balatonfured
Zala Megyei Szent Rafael Korhaz
N/A, Zrinyi Miklos Utca 1, 8900, Zalaegerszeg
Regia Med Kft.
N/A, Bregyo Koz 5, 8000, Szekesfehervar
Clindiab Kft.
N/A, Szakolcai Utca 8/XVIII, XVIII Kerulet, Budapest XVIII
Obudai Egeszsegugyi Centrum Kft.
N/A, Zarda Utca 11-13, 8900, Zalaegerszeg
Medifarma-98 Kft.
N/A, Praga Utca 9, 4400, Nyiregyhaza
University Of Debrecen
N/A, Bartok Bela Ut 2-26, 4031, Debrecen
Szent Lazar Megyei Korhaz
N/A, Fuleki Ut 54-56, 3100, Salgotarjan
Trantor 99 Bt.
N/A, Damjanich Janos Ut 127, Kerulet, Budapest XXI
Obudai Egeszsegugyi Centrum Kft.
N/A, Lajos Utca 74-76, 1036, Budapest III
Obudai Egeszsegugyi Centrum Kft.
N/A, Ground Floor 1 Door, Arany Janos Ter 2, Kaposvar
University Of Szeged
N/A, Kalvaria Sugarut 57, 6725, Szeged
Salvia Lekston I Madej Sp. J.
N/A, Ul. Panewnicka 201/1, 40-772, Katowice
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
Klimed MK Sp. z o.o.
KLIMED Marek Klimkiewicz, Aleja Jana Pawla II 59/6u, 15-704, Bialystok
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A., Ul. Dr Stefana Kopcinskiego 21, 90-242, Lodz
RST Rehabilitacja
N/A, Królowej Jadwigi 11, 32-089, Bialy Kosciol, Małopolskie
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.
Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET, Ul. Rusznikarska 17, 31-261, Cracow
Ambulatorium Sp. z o.o.
Ambulatorium Sp. z o.o., Ul. Topolowa 28, 82-300, Elblag
Pratia S.A.
N/A, Ul. Dabrowki 13, 40-081, Katowice
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
N/A, Ul. 3 Maja 13/15, 41-800, Zabrze
NBR Polska
NBR Polska, 31 Aleja Wincentego Witosa, 00-710, Mazowieckie
Metabol KLINIK s.r.o.
Ambulancia pre diabetológiu, poruchy látkovej premeny a výživy, Cukrova 3, 811 08, Stare Mesto
Human-Care s.r.o.
Ambulancia diabetológie a porúch látkovej premeny a výživy, Rastislavova 45, 040 01, Kosice 1
Areteus s.r.o.
Diabetologická ambulancia, M. R. Stefanika 25a/3782, 075 01, Trebisov
Medi-Dia s.r.o.
Diabetologická ambulancia, Namestie Slobody 65, 083 01, Sabinov
MediVet s.r.o.
Diabetologická ambulancia, Jana Holleho 1672/24, 901 01, Malacky
Diabint s.r.o.
Ambulancia vnútorného lekárstva, diabetológie, poruchy látkovej premeny a výživy, Sidonie Sakalovej 161/16, Velka Bytca, Bytca
Tatratrial s.r.o.
Ambulancia diabetológie a porúch látkovej premeny a výživy, Namestie 1. Maja 11, 048 01, Roznava
MediTask s.r.o.
Diabetologická ambulancia, Vajnorska 1354/40, Nove Mesto, Bratislava
Vseobecna Nemocnica S Poliklinikou n.o.
Ambulancia diabetológie a porúch látkovej premeny a výživy, Namestie Republiky 15, 984 01, Lucenec
Hospital Quironsalud Infanta Luisa
Endocrinology and metabolism, Calle De San Jacinto 87, 41010, Sevilla
Hospital General Universitario Gregorio Maranon
Endocrinology, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Virgen De Las Montanas
Medicina Interna, Paseo Ambulatorio Sn, 11650, Villamartin
Hospital Universitario Reina Sofia
Medicina Interna, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Virgen Del Camino
Medicina Interna, Carretera De Chipiona Sn, 11540, Sanlucar De Barrameda
Hospital Universitario De La Ribera
Endocrinology, Carretera Corbera 1, 46600, Alzira
University Hospital Virgen Del Rocio S.L.
Endocrinology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitari Vall D Hebron
Endocrinology and metabolism, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Nisa Sevilla Aljarafe
Unidad de Salud Metabólica. Diabetes y Obesidad, Avenida Placido Fernandez Viagas S/n, 41950, Castilleja De La Cuesta
Hospital Universitario Marques De Valdecilla
Endocrinology and metabolism, 5 Planta, Avenida Valdecilla S/n, Santander
University Hospital Son Espases
Endocrinology, Carretera Valldemossa 79, 07120, Palma
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Endocrinology, Av Alcalde Rovira Roure 80, 25198, Lleida
Hospital Universitario Virgen De La Victoria
Endocrinology and metabolism, Calle Del Arroyo Teatinos S N, 29010, Malaga
Area Sanitaria De Ferrol
Endocrinology, Avenida Residencia S/n, 15405, Ferrol
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 | 2023-09-05 | 2026-05-04 | 2023-09-12 | 2024-10-04 | |
| Poland | 2023-09-11 | 2026-04-21 | 2023-09-13 | 2024-10-04 | |
| Slovakia | 2023-09-05 | 2026-04-30 | 2023-09-08 | 2024-10-04 | |
| Spain | 2023-09-12 | 2026-04-08 | 2023-09-15 | 2024-10-04 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 125 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-503659-88-00_Redacted | c |
| Protocol (for publication) | D4_Patient facing documents_copyright | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_List of sites_TC | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_TC | 2.0 |
| Recruitment arrangements (for publication) | K2_Other subject information material_ES_Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Other subject information material_ES_Flyer | 1.0 |
| Recruitment arrangements (for publication) | K2_Other subject information material_ES_Poster | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Appreciation Items | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Digital_Ads_Comorbidities_Master | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Digital_AdsGeneral_Chronic_Weight_Master | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Master_CC_WS_Script | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Program_Database_Messaging_Master | 3.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Program_Website | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Program_Website_Policies_Master | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Screener_Master | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_Search Ads_Master | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_SocialMediaVideo_Chronic_Weight | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_SocialMediaVideo_Obesity | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_SocialMediaVideo_Obesity_and_Establish_CVD | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CWM_SocialMediaVideo_Program | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GZBM_Patient_Messaging | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_GZBM_Website __ | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Flyer | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_List of planned sites_Redacted | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_List of sites | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Obesity_and_Establish_CVD_Social_Media_Video_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Paper_PL_C-SSRS-Baseline Screening | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PL_ IFU | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PL_Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PL_C-SSRS-Since Last Assessed | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PL_Chronic_Weight_Social_Media_Video_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PL_Diet and Physical Activity Log | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PL_Digital_Ads_Comorbidities_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PL_Digital_Ads_General_Chronic_Weight_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PL_Master_CC_WS_Script_Master | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PL_Obesity_Social_Media_Video_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PL_Patient_Messaging_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PL_Program_Database_Messaging_Master | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PL_Program_Social_Media_Video_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PL_Program_Website_Copy_Master | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PL_Program_Website_Policies_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PL_Screener_Edition 2_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PL_Search_Ads_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_PL_Website_Copy_Master | 3 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment and ICF procedure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_TRIAL-BROCHURE_MASTER | 1 |
| Recruitment arrangements (for publication) | N2_List of planned sites_Poland | 1 |
| Subject information and informed consent form (for publication) | Justification for race and ethnicity collection | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Data Privacy Addendum | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DEXA_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Greenphire | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF SoC_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_SoC_PL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_TC_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_SoC_24Jan2025_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_TC_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_TC_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_V4_Redacted | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of changes_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS anf ICF Genetic | 1 |
| Subject information and informed consent form (for publication) | L1_SIS anf ICF Main_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ Greenphire_ClinCard_Cardholder_FAQ_EU | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material__EC_packet_w_Data_Privacy_as_applied_to_GP | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appreciation Items | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Bags | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CARE PARTER GUIDE MASTER | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Certificate Lug Stainless Steel Bottle | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Clinical Trial Ancillary Supply List | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CONTACT-CARD_MASTER | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CWM_Losing weight and re-entering the social scene | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_CWM_Why is it so difficult to lose weight | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Food Bag Lunch Set Product Certificate | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Getting back in the game after significant weightloss | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GI AE REFERENCE CARD | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire ClinCard Msg Templates - ROW | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire EU Generic ClinCard | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_ClinCard_Card_Carrier_EU | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Greenphire_Fee_Schedule | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GZBM_Appreciation Items_v2 | 2 |
| 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 | 2.0 |
| 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_Shopping List | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Study Guide | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Thank You_Dropout | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Thank You_End of Study | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Thank You_Participation | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Thank You_Screening | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Visit Card | 1 |
| 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_HYPOGLYCAEMIA ONE PAGE AWARENESS BROCHURE | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Letter_Participant_Welcome | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_LETTER-PARTICIPANT-WELCOME_MASTER | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Emergency Card_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PL_CARE-PARTER-GUIDE_MASTER | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PL_GI-AE-REFERENCE-CARD_Poland | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PL_HYPOGLYCAEMIA-ONE-PAGE-AWARENESS-BROCHURE_Poland | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PL_Study Guide | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PL_Trial_Brochure | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_PL_Visit Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_RETATRUTIDE IFU | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_STUDY-GUIDE_MASTER | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_VISIT-CARD_MASTER | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information_getting back in the game after significant weight loss | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_losing weight and re-entering the social scene | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_why is it so difficult to lose weight | 1 |
| Subject information and informed consent form (for publication) | L2_Patient cards | 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 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2023-503659-88_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES 2023-503659-88_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_HU 2023-503659-88_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL 2023-503659-88_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SK_2023-503659-88_Redacted | c |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SK_2023-503659-88_TC_Redacted | 1.1 |
Application history
11 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-09 | Hungary | Acceptable 2023-08-21
|
2023-08-22 |
| 2 | SUBSTANTIAL MODIFICATION | SM-5 | 2023-12-13 | Hungary | Acceptable 2024-02-28
|
2024-03-01 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-04-04 | Hungary | Acceptable 2024-02-28
|
2024-04-04 |
| 4 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-04-17 | Acceptable | 2024-05-30 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-04-17 | Acceptable | 2024-06-07 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-04-17 | 2024-06-03 | ||
| 7 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-04-18 | Hungary | Acceptable | 2024-05-24 |
| 8 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-03-06 | Hungary | Acceptable 2025-05-05
|
2025-05-06 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-09-09 | Acceptable 2025-05-05
|
2025-09-09 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-10-06 | Hungary | Acceptable 2026-01-26
|
2026-01-27 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-02-04 | Hungary | Acceptable 2026-01-26
|
2026-02-04 |