Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
1,250
Countries
4
Sites
17
Peripheral Arterial Disease
To demonstrate that orforglipron is superior to placebo in increasing maximum walking distance.
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
- 17 Feb 2026 → ongoing
- Decision date (initial)
- 2026-02-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Pharmacokinetic, Efficacy
To demonstrate that orforglipron is superior to placebo in increasing maximum walking distance.
Conditions and MedDRA coding
Peripheral Arterial Disease
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Have symptoms of Peripheral Artery Disease (PAD), causing pain when you walk
Exclusion criteria 4
- Have a BMI less than 23 kg/m2
- Have HbA1c greater than 10%
- Have had or plan to have a leg surgery to improve blood flow in your legs
- Have had a heart condition within 60 days prior to screening
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percent Change from Baseline in Maximum Walking Distance On a constant load treadmill test [Time Frame: Baseline, Week 52]
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
PRD12263029 · 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
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12263031 · 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
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12263027 · 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
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12263028 · 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
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12263030 · 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
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD12263032 · 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
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 52 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 19
| Organisation | City, country | Duties |
|---|---|---|
| Inventus Group Limited ORL-000015947
|
Wokingham, United Kingdom | Code 14 |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | Code 11 |
| Lionbridge Technologies Inc ORL-000015975
|
Waltham, United States | Other |
| Tier 1 Impact Pbc Inc. ORG-100050163
|
Covington, United States | Other |
| IQVIA Limited ORG-100008655
|
Livingston, United Kingdom | Laboratory analysis |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
| Zoom ORL-000012319
|
San Jose, United States | Other |
| Icon Public Limited Company ORG-100042517
|
Dublin 18, Ireland | Code 8 |
| The Hibbert Co. ORG-100047639
|
Trenton, United States | Other |
| Colorado Prevention Center ORG-100046058
|
Aurora, United States | Code 14 |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Code 13 |
| Clinical Trial Media Inc. ORG-100046339
|
Hauppauge, United States | Other |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
| Clinical Ink Inc. ORG-100042433
|
Winston Salem, United States | Data management |
| Greenphire LLC ORG-100041621
|
King Of Prussia, United States | Code 2 |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Other |
| Iqvia Inc. ORQ-110192931
|
Durham, United States | On site monitoring |
| Florence ORL-000012320
|
Atlanta, United States | Other |
| Reify Health Inc. ORG-100049669
|
Boston, United States | Code 2 |
Locations
4 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 60 | 7 |
| Netherlands | Authorised, recruitment pending | 50 | 3 |
| Poland | Ongoing, recruiting | 50 | 5 |
| Slovakia | Ongoing, recruiting | 25 | 2 |
| Rest of world
Brazil, Taiwan, United Kingdom, Canada, Argentina, United States, Australia, India, Japan, Korea, Republic of, China
|
— | 1,065 | — |
Investigational sites
Hôpital Européen Georges Pompidou
Service de médecine vasculaire ,7e Pôle C, 20 Rue Leblanc,, 75015, Paris
Groupe hospitalier Paris saint Joseph
Services de Chirurgie Vasculaire, 185, Rue Raymond Losserand, Losserand
Centre Hospitalier Universitaire d'Angers
Médecine Vasculaire, 4 rue Larrey, Angers, Angers
Hôpital Saint Philibert
Chirurgie et medecine vasculaire, Rue du Grand But, Lomme, Lomme
Centre Hospitalier Universitaire De Nice
Chirurgie et Médecine Vasculaire, 30 Voie Romaine, 06000, Nice
Centre Hospitalier Universitaire de Rennes , Hôpital Pontchaillou
Centre d'Investigation Clinique CIC1414, 2 Rue Henri Le Guilloux, RENNES, RENNES
CHRU Troussau
Cardiologie, Avenue de la République, Chambray Les Tours, Chambray Les Tours
Catharina Ziekenhuis Stichting
Vascular Surgery, Michelangelolaan 2, 5623 EJ, Eindhoven
Albert Schweitzer Ziekenhuis
Interne Geneeskunde, Albert Schweitzerplaats 25, 3318 AT, Dordrecht
Radboud UMC
Vascular Surgery, Geert Grooteplein-Zuid 10, 6500 HB Nijmegen, HB Nijmegen
Centrum Medyczne Intercor Sp. z o.o.
Badania Kliniczne, Ul. Kasztanowa 57, 85-605, Bydgoszcz
Przychodnie Grudziadz Sp. z o.o.
N/A, Ul. Legionow 21/23, 86-300, Grudziadz
Serce Sp. z o.o.
Poradnia Specjalistyczna, Ul. Fabryczna 15, 64-100, Leszno
Niepubliczny Zaklad Opieki Zdrowotnej Twoje Zdrowie El Sp. z o.o.
Poradnia Kardiologiczna, Ul. Robotnicza 79, 82-300, Elblag
Centrum Medyczne Komorniki Sp. z o.o.
Poradnia Kardiologiczna, Ul. Stawna 7, 62-052, Komorniki
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 |
|---|---|---|---|---|---|
| France | 2026-02-17 | 2026-04-07 | |||
| Poland | 2026-02-22 | 2026-04-10 | |||
| Slovakia | 2026-05-08 | 2026-05-18 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 97 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-523283-21-00_Redacted | a |
| Protocol (for publication) | D4_Patient Documents Copyright | 1 |
| Protocol (for publication) | D4_Patient facing document_PGIS-PAD Walking Ability_eCOA_PL | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FRA | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Redacted | 1.2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangments_PL | 1 |
| Recruitment arrangements (for publication) | K2_Document additionnel_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Appreciation Items | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure_FRA_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Master_PL_redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_CC_Script_Secondary_Master_PL_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Database_and_Patient_Messaging_Master_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital_Ad_Copy_Master_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Digital_Ad_Visuals_Master_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Doctor Referral Letter TC_FRA_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Doctor Referral Letter_FRA_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Flyer_FRA_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_Master_PL_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter-Doctor-Referral_Master_PL_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter-Doctor-to-Patient_Master_PL_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_List of sites_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_LITES Survey Participant Invitation Email_FRA | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Poster_FRA_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_Master_PL_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Screener_Secondary_Master_PL_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Social_Media_Video_Script_1_Master_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_WS_Script_Secondary_Master_PL | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Brochure_Redacted | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Doctor to Patient Letter_Redacted | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Flyer_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_Poster_Redacted | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruitment_Materials_Flyer_Redacted | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruitment_Materials_Poster_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_GZPR_Main TC_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_GZPR_Main_FR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Data Privacy Addendum | 1.1 |
| 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 | 1.6 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_PL_Redacted | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Confidentiality Notice_Netherlands_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent - Participant-Facing Screenshots_Redacted | 1.4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent Security and Privacy Quick Reference Guide_Redacted | 1.5 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent Submission Letter | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eSignature In-Person Consent Quick Reference Guide | 1.2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_GI-AE Brochure | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Hypo Awareness Brochure | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IQVIA E2E Privacy Policy | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IQVIA Getting Started Patient-facing landing page_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Lilly In Trial Experience Survey LITES Ethics Cover Letter | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Lilly In-Trial Experience Survey LITES Privacy Policy | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Lilly In-Trial Experience Survey LITES Study Specific Form | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Lilly In-Trial Experience Survey LITES Terms of Use | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_LITES Participant Invitation Email | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_LITES Study Participant and Study Partner Survey | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_LITES_Ethics Cover Letter_Template | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_LITES_Participant Invitation Email_Template_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_LITES_Privacy Policy_Master_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_LITES_Study Participant and Study Partner Survey_Master_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_LITES_Study Participant_Study Partner Survey_Screenshots_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_LITES_Study Specific Form | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_LITES_Terms of Use_Master_PL | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Postcard Anytime | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Postcard During study | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Postcard End of study | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant Postcard Start of study | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Information Card | 2 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Connect Participant | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Guide_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Supportive Partner Guide | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Survey_Participant_Postcard Anytime_Master_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Survey_Participant_Postcard During study_Master_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Survey_Participant_Postcard End of study_Master_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Survey_Participant_Postcard Start of study_Master_PL | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Card | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_LITES Survey Participant Invitation Email_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_LITES Survey Participant Postcard Anytime_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_LITES Survey Participant Postcard During Study_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_LITES Survey Participant Postcard End of Study_FRA | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_LITES Survey Participant Postcard Start of Study_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_LITES Survey Privacy Policy_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_LITES Survey Screenshots_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_LITES Survey Study-Specific Form | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_LITES Survey Terms of Use_FRA | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_LITES Survey_FRA | 1.0 |
| Subject information and informed consent form (for publication) | L3_Recruitment arrangements_Informed consent and patient recruitment procedure_PL | 2 |
| Subject information and informed consent form (for publication) | L4_Info Re insurance Conditions for Patient | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2025-523283-21-00_FR_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2025-523283-21-00_PL_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_NL_2025-523283-21-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_SK_2025-523283-21-00_Redacted | initial |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-15 | Netherlands | Acceptable 2026-02-16
|
2026-02-17 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-03-04 | Acceptable | 2026-06-01 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-03-06 | Acceptable | 2026-04-16 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-10 | Acceptable | 2026-04-29 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-10 | Netherlands | Acceptable | 2026-05-22 |