Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
460
Countries
4
Sites
34
Heart Failure with Preserved Ejection Fraction
To demonstrate that LY3540378 administered SC is superior to placebo for improving atrial myopathy in participants with worsening chronic HFpEF.
Key facts
- Sponsor
- Eli Lilly & Co.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 28 Mar 2023 → 19 Nov 2024
- Decision date (initial)
- 2024-11-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-505902-40-00
- EudraCT number
- 2022-000780-48
- WHO UTN
- U1111-1298-3979
- ClinicalTrials.gov
- NCT05592275
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Safety, Pharmacokinetic, Efficacy, Dose response
To demonstrate that LY3540378 administered SC is superior to placebo for improving atrial myopathy in participants with worsening chronic HFpEF.
Conditions and MedDRA coding
Heart Failure with Preserved Ejection Fraction
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Have chronic heart failure
Exclusion criteria 4
- Have heart transplant
- Have uncontrolled irregular heart beats
- Have heart failure triggered by blood clot in lungs
- Have stroke
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from Baseline in Left Atrial Reservoir Strain (LARS)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Igg Against Serum Albumin Fused with Relaxin 2, Chain B (2-29) and Relaxin 2 (Chain A)
PRD10933250 · Product
- Active substance
- Igg Against Serum Albumin Fused with Relaxin 2, Chain B (2-29) and Relaxin 2 (Chain A)
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- 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 10
| Organisation | City, country | Duties |
|---|---|---|
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Other |
| PPD Development LP ORG-100011560
|
Richmond, United States | Laboratory analysis |
| Praxis Communications LLC ORG-100045170
|
Buffalo, United States | Other |
| Iqvia Rds Inc. ORG-100043858
|
Durham, United States | On site monitoring, Other, Code 5 |
| Eresearchtechnology Inc. ORG-100013039
|
Philadelphia, United States | Laboratory analysis |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
| The Brigham And Women’s Hospital Inc. ORG-100030562
|
Boston, United States | Laboratory analysis |
| Medable Inc. ORG-100043083
|
Palo Alto, United States | Data management |
| PRA Health Sciences ORL-000003597
|
Lenexa, United States | Laboratory analysis |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
Locations
4 EU/EEA countries · 34 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ended | 10 | 3 |
| Hungary | Ended | 36 | 6 |
| Poland | Ended | 84 | 13 |
| Spain | Ended | 65 | 12 |
| Rest of world
Japan, Argentina, Turkey, United Kingdom, United States, Brazil, Canada, Israel
|
— | 265 | — |
Investigational sites
Vseobecna Fakultni Nemocnice V Praze
II. interní klinika kardiologie a angiologie 1.LF UK a VFN, U Nemocnice 499/2, Nove Mesto, Prague
Fakultni Nemocnice U Sv Anny V Brne
II. Interní klinika, Pekarska 53, Stare Brno, Brno-Stred
Fakultni Nemocnice Brno
Interní kardiologická klinika, Jihlavska 340/20, Bohunice, Brno
Belvarosi Egeszseghaz Kft.
No Department, Platan Sor 2-4, 8900, Zalaegerszeg
Semmelweis University
Varosmajori Sziv-es Ergyogyaszati Klinika, Varosmajor Utca 68, Kerulet, Budapest XII
Kistarcsai Flor Ferenc Korház
V. Belgyogyaszat, Semmelweis Ter 1, 2143, Kistarcsa
University Of Szeged
Szent-Gyorgyi Albert Klinikai Kozpont, Tisza Lajos Korut 109, 6725, Szeged
Medifarma-98 Kft.
No Department, Praga Utca 9, 4400, Nyiregyhaza
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Belgyogyaszat- Angiologia-Nefrologiai osztaly Kardiovaszkularis ambulancia, Nagyvarad Ter 1, 1097, Budapest Ix
Centermed Sp. z o.o.
N/A, Ul. Weteranow 46, 20-044, Lublin
Klimed MK Sp. z o.o.
N/A, Aleja Jana Pawla II 59/6u, 15-704, Bialystok
Wojewodzki Szpital Im. Sw.Ojca Pio W Przemyslu
Oddzial Kardiologiczny, Ul. Monte Cassino 18, 37-700, Peremyshl
Provita Familia
N/A, ul. Kostromska 66a,, Piotrkow, Trybunalski
Specjalistyczna Praktyka Lekarska Ewa Mirek-Bryniarska
N/A, ul. Kazimierza Wielkiego 118, 30-082, Krakow
Balsammedica Sp. z o.o.
NA, Ul. Goleszowska 1/U5, 01-249, Warsaw
Uniwersytecki Szpital Kliniczny W Bialymstoku
NA, Zurawia 14, 15-540, Bialystok
Irmed Klimkiewicz Rudziewicz-Kowalska sp. j.
N/A, Ul. Polskiej Organizacji Wojskowej 12 C, 97-300, Piotrkow Trybunalski
Uniwersytecki Szpital Kliniczny Im. Wojskowej Akademii Medycznej Uniwersytetu Medycznego W Lodzi Centralny Szpital Weteranow SPZOZ
NA, Ul. Stefana Zeromskiego 113, 90-549, Lodz
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
NA, Ul. Pabianicka 62, 93-513, Lodz
Centrum Medyczne Intercor Sp. z o.o.
N/A, Ul. Kasztanowa 57, 85-605, Bydgoszcz
1 Wojskowy Szpital Kliniczny Z Poliklinika samodzielny publiczny zakład opieki zdrowotnej W Lublinie
NA, Ul. Aleje Raclawickie 23, 20-049, Lublin
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
N/A, Ul. Krolowej Jadwigi 16, 85-231, Bydgoszcz
Hospital Universitario 12 De Octubre
Cardiology, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital San Juan de la Cruz
Internal Medicine, Avenida Ciudad de Linares Km 1, 23400, Ubeda, Jaen
Bellvitge University Hospital
UMICO, Carrer De La Feixa Llarga Sn, 08907, L'hospitalet De Llobregat
Hospital Universitario Virgen De La Victoria
Cardiology, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Germans Trias I Pujol
Cardiology, Carretera Canyet 1a Planta, 08916, Badalona
Marina Salud S.A.
Cardiology, Partida Beniadla S/n, 03700, Denia
Complexo Hospitalario Universitario De Santiago
Cardiology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Virgen De Valme
Internal Medicine, Avenida Bellavista S/n, 41014, Sevilla
Hospital Clinico Universitario De Valencia
Cardiology, Avenida Blasco Ibanez 17, 46010, Valencia
University Clinical Hospital Virgen De La Arrixaca
Cardiology, Carretera De Cartagena Sn, El Palmar, Murcia
Hospital Universitario Reina Sofia
Cardiology, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitario Ramon Y Cajal
Cardiology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
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 | 2023-03-28 | 2023-04-19 | |||
| Poland | 2023-03-31 | 2023-04-13 | |||
| Spain | 2023-03-28 | 2023-04-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| J3E-MC-EZDB Primary Summary of Results_ 2023-505902-40-00 SUM-103023
|
2025-10-21T15:57:24 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| J3E-MC-EZDB Lay Person Summary of Resulst_ 2023-505902-40-00 | 2026-01-20T05:30:01 | Submitted | Laypersons Summary of Results |
| J3E-MC-EZDB_Lay person summaries_translated copies (Czech, Hungarian, Polish, Spanish) | 2026-03-31T06:12:37 | Submitted | Laypersons Summary of Results |
Documents 116 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | EZDB Plain Language Summary Czech | 1 |
| Laypersons summary of results (for publication) | EZDB Plain Language Summary Hungarian | 1 |
| Laypersons summary of results (for publication) | EZDB Plain Language Summary Polish | 1 |
| Laypersons summary of results (for publication) | EZDB Plain Language Summary Spanish | 1 |
| Laypersons summary of results (for publication) | J3E-MC-EZDB Lay Person Summary of Resulst_ 2023-505902-40-00 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and ICF procedure | 4 |
| 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 arrangments_EZDB_PL | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangments_List of sites_Redacted | 4 |
| Recruitment arrangements (for publication) | K1_Recruitment materials_Dr to Patient Letter_Master | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment materials_Recruitment brochure | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment materials_Recruitment poster | 2.0 |
| Recruitment arrangements (for publication) | K2 Recruitment material_Recruitment_Poster_Master_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Appt_Reminder Card | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Redacted | 3.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Care_Partner_Brochure_Master_PL_Redacted | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Dr to Patient Letter_Master_PL_Redacted | 5 |
| Recruitment arrangements (for publication) | K2_Recruitment material_EN_Doctor to Doctor Letter_Redacted | 4.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Brochure_Redacted | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HU_Poster | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Injection_Reminder_Magnet | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Injection_Reminder_MirrorCling | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment_Brochure_Master_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment_Brochure_Master_PL_Redacted | 4 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Recruitment_Poster | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Thank you_Card | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Visit Guide_Redacted | 3.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_What to expect in Clinical Pamphlet | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_WhattoexpectinClinicalPamphlet_Master_PL | 1 |
| Recruitment arrangements (for publication) | K3_List of planned sites Poland | 1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Addendum ICF for genetic samples | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Genetic | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_Redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DPA | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DPA_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Greenphire ICF | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pharmacogenetic | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pharmacogenetic_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Main ICF_EZDB_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Main ICF_EZDB_Redacted_ | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Reimbursement_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other information material_ConneX_EC_packet_w_Data_Privacy_as_applied_to_GP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other information material_EC_packet_w_Data_Privacy_as_applied_to_GP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other information material_Greenphire ClinCard Msg Templates | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other information material_Greenphire ClinCard Travel Ref Guide for Subjects | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other information material_Greenphire EU Generic ClinCard | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other information material_Greenphire Travel Contact Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other information material_Greenphire_ClinCard_Card_Carrier_EU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other information material_Greenphire_ClinCard_Cardholder_FAQ_EU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other information material_Greenphire_Fee_Schedule | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Appt_Reminder_Card_Master_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Dr-to-Patient_Letter_Master_PL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Emergency Card EZDB | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EZDB DFU of IP A | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EZDB DFU of IP B | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EZDB DFU of IP C | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EZDB Patient Diary_2 injections | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EZDB Patient Diary_4 injections | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EZDB Syringe Injection Guide | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_EZDB Syringe Injection Video Script | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Appointment Reminder Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Care Partner Brochure | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Care Partner Brochure_Redacted | 4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Doctor to Patient Letter | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Doctor to Patient Letter_Redacted | 5 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Injection Reminder Magnet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Injection Reminder Mirror Cling | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Site Contact Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Study Folder | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Thank You Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Visit Guide | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_Visit Guide_Redacted | 3 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_HU_What To Expect Pamphlet | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Injection_Reminder_Magnet_PL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Injection_Reminder_MirrorCling_Master_PL_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Emergency Card | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Site_Contact_Card_Master_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study_Folder_Master_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject Directions for Use_A | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject Directions for Use_B | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Subject Directions for Use_C | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Syringe Injection Guide_v1_WS_Paper | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Syringe Injection Guide_v1_WS_Video | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Thankyou_Card_Master_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit_Guide_Master_PL_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Patient Documents Not submitted_PL | 1 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_ConneX Spain Travel Contact Card | 2.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_ConneX Spain Travel Ref Guide for Subjects | 1.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_Greenphire ClinCard Msg Templates | 6.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_Greenphire EU Generic ClinCard | 3.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_Greenphire_ClinCard_Card_Carrier | 3.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_Greenphire_ClinCard_Cardholder | 3.0 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_Greenphire_Fee_Schedule | 1.0 |
| Subject information and informed consent form (for publication) | L3_Appreciation Item Listing | 1 |
| Subject information and informed consent form (for publication) | L4_Patient Card | 1.0 |
| Subject information and informed consent form (for publication) | L5_Directions for Use_A_HU | 1 |
| Subject information and informed consent form (for publication) | L5_Directions for Use_B_HU | 2 |
| Subject information and informed consent form (for publication) | L5_Directions for Use_C_HU | 1 |
| Subject information and informed consent form (for publication) | L5_Directions for Use_HU_Syringe injection guide | 1 |
| Subject information and informed consent form (for publication) | L5_Directions for Use_HU_Syringe injection video script | 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) | L6_Reimbursement_Greenphire_ClinCard Sample | 3.0 |
| Subject information and informed consent form (for publication) | L6_Reimbursement_Greenphire_EC Submission Overview General | 2.0 |
| Subject information and informed consent form (for publication) | L6_Reimbursement_Greenphire_EC Submission Overview Hungary | 1.0 |
| Subject information and informed consent form (for publication) | L6_Reimbursement_HU_Greenphire_ClinCard FAQ | 3.0 |
| Subject information and informed consent form (for publication) | L6_Reimbursement_HU_Greenphire_ClinCard Guide | 1.0 |
| Subject information and informed consent form (for publication) | L6_Reimbursement_HU_Greenphire_ClinCard Msg Templates | 6.0 |
| Subject information and informed consent form (for publication) | L6_Reimbursement_HU_Greenphire_Fee Schedule_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L6_Reimbursement_HU_Greenphire_Travel Contact Card_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L6_Reimbursement_HU_Greenphire_Travel Guide_Redacted | 3.0 |
| Summary of results (for publication) | J3E-MC-EZDB Primary Summary of Results_ 2023-505902-40-00 | 1 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-29 | Hungary | Acceptable 2024-01-16
|
2024-01-16 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-05-17 | Hungary | Acceptable 2024-07-09
|
2024-07-15 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2024-08-16 | 2024-11-11 | ||
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-08-16 | Acceptable | 2024-10-16 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-09-17 | Hungary | Acceptable | 2024-10-22 |