Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
950
Countries
4
Sites
33
Obesity
To demonstrate that eloralintide is superior to placebo for change in body weight.
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
- 11 May 2026 → ongoing
- Decision date (initial)
- 2026-04-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2025-523659-73-00
- WHO UTN
- U1111-1330-8951
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Diagnosis, Pharmacokinetic, Pharmacodynamic, Efficacy, Therapy
To demonstrate that eloralintide is superior to placebo for change in body weight.
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 on stable incretin therapy at screening
- Have persistent obesity or overweight defined as: o ≥30 kg/m2 OR o ≥27 kg/m2 with at least one existing obesity related complication at screening: hypertension dyslipidemia obstructive sleep apnea cardiovascular disease, or type 2 diabetes
- Have a stable body weight (<5% body weight change) at screening
Exclusion criteria 4
- Participants must NOT: Have had or are planning to have surgery, an endoscopic procedure, and/or device-based therapy for weight loss (with exceptions)
- Participants must NOT: Have type 1 diabetes
- Participants must NOT: Have taken certain medications for blood sugar within 90 days prior to screening
- Participants must NOT: Have had a serious heart condition within 90 days prior to screening
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percent Change from Baseline in Body Weight [Time Frame: Baseline, Week 64]
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD13082122 · Product
- Active substance
- LY3841136 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD13082120 · Product
- Active substance
- LY3841136 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD13082123 · Product
- Active substance
- LY3841136 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD13082121 · Product
- Active substance
- LY3841136 Sodium
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 1 Day(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 9
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | Data management |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| Iqvia Inc. ORG-100010622
|
Durham, United States | Laboratory analysis |
| Care Access Research LLC ORL-000015894
|
Boston, MA, United States | Code 2 |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
| Trialbee AB ORG-100051369
|
Malmo, Sweden | Code 2 |
Locations
4 EU/EEA countries · 33 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 71 | 9 |
| Czechia | Ongoing, recruiting | 62 | 4 |
| Romania | Authorised, recruitment pending | 48 | 10 |
| Spain | Ongoing, recruiting | 105 | 10 |
| Rest of world
Taiwan, Mexico, China, India, Australia, United States, Israel, Brazil, Japan
|
— | 664 | — |
Investigational sites
Imelda General Hospital
Associatie Dialyse Endocrinologie, Wolzakken 22, Imelda GI Clinical Research Center,, Putte
Emmaues
Endocrinologie, Liersesteenweg 435, 2800, Mechelen
Ziekenhuis Oost-Limburg Campus St.-Jan
Cardiology, Synaps Park 1, Building G room G0.03,, Genk
Jan Yperman Ziekenhuis
Departement Endocrinologie-Diabetologie, Briekestraat 12, 8900, Ieper
Algemeen Ziekenhuis Groeninge
Endocrinologie, President Kennedylaan 4, 8500, Kortrijk
Algemeen Ziekenhuis Damiaan Oostende
Endocrinology, Gouwelozestraat 100, 8400, Ostend
Meclinas
Meclinas, Stationsstraat 102-108, 2800, Mechelen
Université Libre de Bruxelles - Hôpital Erasme
Endocrinology, Route de Lennik 808,, 1070, Brussels, Bruxelles-Capitale
UZ Leuven
Endocrinology, Herestraat 49, 3000, Leuven
Diahaza s.r.o.
diabetology, Palackeho 492/62, 769 01, Holesov
ResTrial s.r.o.
N/A, Zhorelecka 514/2, Bohnice, Prague 8
MUDr. Michala Pelikanova s.r.o.
N/A, Krcska 1079/59, 140 00, Praha 4
Milan Kvapil s.r.o.
diabetology, Michnova 1622/4, Chodov, Prague
Easydiet S.R.L.
Diebetes, nutrition and metabolic diseases, Strada Alexandrescu Grigore Nr 80 Sector 1, 010627, Bucharest
Nutrilife S.R.L.
Diebetes, nutrition and metabolic diseases, Strada Dobrogeanu-Gherea Constantin 10-12, 013764, Bucharest
Mariodiab Clinic S.R.L.
Diebetes, nutrition and metabolic diseases, Bulevardul 15 Noiembrie, Nr 75,Bl 75, Brasov
Dentosim-Queen S.R.L.
Diebetes, nutrition and metabolic diseases, Strada Mihai Viteazul 27a, 540098, Targu Mures
Diabdana S.R.L.
Diebetes, nutrition and metabolic diseases, Calea Republicii Nr 77, 410147, Oradea
Gama Diamed S.R.L.
Diebetes, nutrition and metabolic diseases, T S Saveanu Nr 1, 905500, Mangalia
Rinart Diab S.R.L.
Diebetes, nutrition and metabolic diseases, Strada Matei Basarab 65, 130168, Targoviste
Clinica Korall S.R.L.
Diebetes, nutrition and metabolic diseases, Piata Eroilor Revolutiei, Corp A Apartament M 2 Nr 22, Satu Mare
Centrul Medical De Diagnostic Si Tratament Ambulator Neomed S.R.L.
Diebetes, nutrition and metabolic diseases, Block 1 Staircase C Apartment 2 Room 2, Strada Crisului Nr 1, Brasov
Cabinet Medical Dr Geru S.R.L.
Diebetes, nutrition and metabolic diseases, Aleea Lirei Nr 1, Ap. 2, Timisoara
Hospital Universitari Vall D Hebron
Endocrinology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
NA, Calle Alejo Fernandez 9, 41003, Sevilla
Instituto Gallego de Cirugía Ocular
Endocrinology, Calle de la Tierra, 26, Ferrol
Hospital Universitario Marques De Valdecilla
Endocrinology, Diabetes and Nutrition, Avenida Valdecilla Sn, 39008, Santander
Hospital Nisa Sevilla Aljarafe
Endocrinology and nutrition, Avenida Placido Fernandez Viagas S/n, 41950, Castilleja De La Cuesta
Instituto Medico Quirurgico San Rafael S.A.
Endocrinology, Poboado Nucleo Rural La Jubias 82, 15006, A Coruna
Hospital Universitario Quironsalud Madrid
Endocrinology and nutrition, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Quironsalud Infanta Luisa
Endocrinology, Calle De San Jacinto 87, 41010, Sevilla
Clinica Juaneda S.A.
Endocrinology, Calle Company 30, 07014, Palma
Hospital Universitario Torrecardenas
Endocrinology, Calle Paraje Torrecardenas S/n, 04009, Almeria
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2026-05-20 | 2026-05-21 | |||
| Spain | 2026-05-11 | 2026-05-11 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 129 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-523659-73-00_Redacted | c |
| Protocol (for publication) | D1_Protocol addendum EU 2025-523659-73-00_Redacted | 2 |
| Protocol (for publication) | D4_Patient Documents Copyright_2025-523659-73-00 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and consenting procedure_Annex 3 | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Recruitment and Informed Consent Procedure | 1.0 |
| Recruitment arrangements (for publication) | K2_Brochure_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Doctor to Patient Letter_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_ENLIGHTEN_Trialbee_Digital Marketing Content_RO | 1 |
| Recruitment arrangements (for publication) | K2_ENLIGHTEN_Trialbee_Landing Page_RO_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_ENLIGHTEN_Trialbee_OverviewSupplementaryInformation | 1 |
| Recruitment arrangements (for publication) | K2_ENLIGHTEN_Trialbee_Secondary Assessment_RO_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_ENLIGHTEN_Trialbee_Self_Assessment_RO_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Flyer_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Poster_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Arrangements_Meclinas recruitment plan_BEDU_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Arrangements_Meclinas Website Text_BEDU_Redacted | 3.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Arrangments_Meclinas Slagzinnen_BEDU | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure Master_CZRedacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure_BEDU_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure_BEFR_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Flyer_BEDU_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Flyer_BEFR_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HbA1c Brochure | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_HbA1c-Brochure-OUS_CZ | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter Dr referral_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter Dr to patient_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter-Doctor-Referral_Master_CZ_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Letter-Doctor-To-Patient_BEDU_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Letter-Doctor-To-Patient_BEFR_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter-Doctor-To-Patient_CZ_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Meclinas Post_BEDU_Redacted | 2.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Meclinas Poster_BEDU_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_BEDU_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Poster_BEFR_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Digital Marketing Content_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Digital Marketing Content_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Digital Marketing Content_English_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Landing Page_BEDU_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Landing Page_BEFR_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Landing Page_English_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Overview_English | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Privacy Policy_BEDU | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Privacy Policy_BEFR | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Privacy Policy_English | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Secondary Assessment_BEDU_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Secondary Assessment_BEFR_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Secondary Assessment_English_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Self_Assessment_BEDU_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Self_Assessment_BEFR_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Self_Assessment_English_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Trialbee_Global Privacy Policy_RO | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment digital campaign_Trialbee_Digital Marketing Content | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment digital campaign_Trialbee_Global Privacy Policy | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment digital campaign_Trialbee_Landing page_Redaction | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment digital campaign_Trialbee_Overview Supplementary Information | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment digital campaign_Trialbee_Secondary Assessment_Redacted | 1 |
| Recruitment arrangements (for publication) | K3_Recruitment digital campaign_Trialbee_Self Assessment_Redaction | 1 |
| Subject information and informed consent form (for publication) | L1_Main ICF_RO_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_Optional PreScreening V601 ICF | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional PreScreening BEDU | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional PreScreening BEFR | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional PreScreening English | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DPA_CZ | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_BEDU_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_BEFR_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_CZ_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_ENG_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional prescreening | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional_PreScreening_CZ_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant partner_Redacted | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Compensation Information Sheet_English_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent_Landing page_BEDU_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent_Landing page_BEFR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent_Participant Facing Screenshots_BEDU_Redacted | 1.4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent_Participant Facing Screenshots_BEFR_Redacted | 1.4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent_Privacy Policy_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent_Privacy Policy_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent_Security and Privacy_BEDU_Redacted | 1.5 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent_Security and Privacy_BEFR_Redacted | 1.5 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent_Submission Letter_English | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ENG_ICF sponsor statement_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_BEDU_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_BEFR_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IFU_English_Redacted | 2.0 |
| 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_ZoomHealth_Privacy Statement_English | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_PrivacyStatement_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_PrivacyStatement_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_Screenshots_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_Screenshots_BEFR | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_Screenshots_English | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_TermsofService_BEDU | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_TermsOfService_English | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_ZoomHealth_TermsofService_French | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_IFU_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Other_subject_information_material_Compensation_Information_Sheet_BEDU_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other_subject_information_material_Compensation_Information_Sheet_BEFR_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Patient Cards | 1 |
| Subject information and informed consent form (for publication) | L2_Retention material_CT_GI-AE-Brochure_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Retention material_CT_Study-Connect-Participant_Edition1_Master_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Retention material_CT_Study-Connect-Participant_Edition2_Master_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Retention material_CT_Study-Connect-Participant_Edition3_Master_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Retention material_CT_Study-Connect-Participant_Edition4_Master_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Retention material_CWM_Health-Journey-Support_Master_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Retention material_Study-Connect-Participant_Master_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Retention material_Study-Guide_Master_CZ_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Retention material_Welcome-Guide_Master_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Retention material_Welcome-Guide-DG_Master_CZ | 1 |
| Subject information and informed consent form (for publication) | L2_Study Participant Contact Card | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information material_Triabee_Global Privacy Policy | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information material_Triabee_Overview Supplementary Information | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information material_Triabee_Self_Assessment_Redacted | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information material_Trialbee_Digital Marketing Content | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information material_Trialbee_Landing Page_Redacted | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information material_Trialbee_Secondary Assessment_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BE_2025-523659-73-00_BEDE_REDACTED | b |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BE_2025-523659-73-00_BEDU_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis BE_2025-523659-73-00_BEFR_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ_2025-523659-73-00_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG_2025-523659-73-00_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2025-523659-73-00_Redacted | b |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_RO_2025-523659-73-00_Redacted | b |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-12-09 | Czechia | Acceptable with conditions 2026-04-20
|
2026-04-21 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-04-30 | Acceptable with conditions | 2026-05-08 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-04-30 | Czechia | Acceptable with conditions | 2026-05-19 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-05-01 | Acceptable with conditions | 2026-06-03 |