Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
905
Countries
5
Sites
44
Obesity
To demonstrate that tirzepatide is superior to placebo for glycemic control.
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
- 23 Jun 2025 → ongoing
- Decision date (initial)
- 2025-06-02
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-519684-17-00
- WHO UTN
- U1111-1317-7664
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacokinetic, Efficacy, Safety
To demonstrate that tirzepatide is superior to placebo for glycemic control.
Conditions and MedDRA coding
Obesity
Regulatory references
- Scientific advice from competent authorities
- European Medicines Agency
- Plan to share IPD
- Yes
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-504413-80-00 | I8F-MC-GPHP: Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly versus Placebo in Adolescent Participants Who have Obesity or are Overweight with Weight-Related Comorbidities: A Randomized, Double-Blind Trial (SURMOUNT-ADOLESCENTS) | Eli Lilly & Co. |
| 2022-501073-40-00 | I8F-MC-GPHE: A Randomized, Open-Label, Parallel-Group, Two-Arm, Phase 4 Study to Evaluate the Long-Term Efficacy and Safety of Tirzepatide Compared with Intensified Conventional Care in Adults When Initiating Treatment Early in the Course of Type 2 Diabetes (SURPASS-EARLY) | Eli Lilly & Co. |
| 2023-507655-30-00 | I8F-MC-GPIX: Efficacy and Safety of Tirzepatide Once Weekly Versus Placebo for the Treatment of Obesity and Weight-Related Comorbidities in Adolescents: A Randomized, Double-Blind, Placebo- Controlled Trial (SURMOUNT-ADOLESCENTS-2) | Eli Lilly & Co. |
| 2023-507846-96-00 | I8F-MC-GPGN: The Effect of Tirzepatide versus Dulaglutide on Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes (SURPASS-CVOT) | Eli Lilly & Co. |
| 2022-501744-15-00 | I8F-MC-GPIJ: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Effect of Tirzepatide on the Reduction of Morbidity and Mortality in Adults with Obesity | Eli Lilly & Co. |
| 2023-506082-60-00 | I8F-MC-GPIG - Tirzepatide Study of Renal Function in People with Overweight or Obesity and Chronic Kidney Disease with or without Type 2 Diabetes: Focus on Kidney Hypoxia in Relation to Fatty Kidney Disease using Multiparametric Magnetic Resonance Imaging (TREASURE-CKD) | Eli Lilly & Co. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Have had type 1 diabetes and on insulin treatment for at least one year
- Have blood glucose levels within allowed limits for study participation
- Have obesity or overweight
- Minimum Age: 18 Years
Exclusion criteria 3
- Have had 2 or more hospitalization for very high blood glucose in the past 6 months.
- Have had 1 or more emergency treatment for very low blood glucose in the past 3 months.
- Are receiving or planning to receive treatment for diabetic eye disease
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Change from Baseline in Hemoglobin A1c (HbA1c) [Time Frame: Baseline, Week 40]
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 6
PRD11922454 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD11922457 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD11922455 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD11922453 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD11922456 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- No
PRD11922458 · Product
- Active substance
- Tirzepatide
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED PEN
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 40 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 15
| Organisation | City, country | Duties |
|---|---|---|
| Clinical Ink ORL-000013361
|
Horsham PA, United States | Data management |
| Bioagilytix Labs LLC ORG-100013030
|
Durham, United States | Laboratory analysis |
| IQVIA ORL-000013405
|
Durham NC, United States | Laboratory analysis |
| Q2 Solutions LLC ORG-100017000
|
Ithaca, United States | Laboratory analysis |
| Veeva Systems Inc. ORG-100006053
|
Pleasanton, United States | E-data capture |
| RWS Life Sciences Inc. ORG-100042348
|
East Hartford, United States | Data management |
| R Square Technology Inc. ORL-000009672
|
Chesterbrook, United States | Code 10 |
| R&G US Inc. ORG-100048358
|
North Potomac, United States | Code 10 |
| Q Squared Solutions Limited ORG-100042527
|
Livingston, United Kingdom | Laboratory analysis |
| IQVIA ORL-000013359
|
Durham NC, United States | Other |
| IQVIA ORL-000013355
|
Durham NC, United States | On site monitoring |
| Q2 Solutions ORL-000013404
|
Durham NC, United States | Laboratory analysis |
| ACI Clinical WCG Clinical ORL-000013356
|
Bala Cynwyd PA, United States | Code 10 |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other |
| Cleveland Clinic Foundation ORG-100028017
|
Cleveland, United States | Other |
Locations
5 EU/EEA countries · 44 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruitment ended | 93 | 5 |
| France | Ongoing, recruitment ended | 93 | 13 |
| Germany | Ongoing, recruitment ended | 62 | 10 |
| Italy | Ongoing, recruitment ended | 62 | 8 |
| Spain | Ongoing, recruitment ended | 62 | 8 |
| Rest of world
Brazil, Mexico, Japan, United States, Israel, Argentina
|
— | 533 | — |
Investigational sites
Esbjerg Og Grindsted Sygehus
N/A, Finsensgade 35, 6700, Esbjerg
Region Sjaelland
N/A, Lykkebaekvej 1, 4600, Koege
Regionshospitalet Goedstrup
N/A, Hospitalsparken 15, 7400, Herning
Nordsjællands Hospital
N/A, Dyrehavevej 29, 3400, Hillerød
Steno Diabetes Center Copenhagen
NA, Borgmester Ib Juuls Vej 83, 2730, Herlev
Hopital de la Conception
Endocrinology - Metabolic diseases - Nutrition, 147 Boulevard Baille, Marseille, Marseille
Centre Hospitalier Universitaire De Montpellier
AMTIM, 191 Avenue Du Doyen Gaston Giraud, 34295, Montpellier Cedex 5
Hopital Europeen Marseille
Diabetology - Endocrinology, 6 Rue Desiree Clary, 13003, Marseille
Hopital le Creusot - Groupe SOS - Site Foch
diabetologie, 26, rue d'Harfleur, Le Creusot
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
Endocrinology, 54 Rue Henri Sainte Claire Deville, 83100, Toulon
Les Hopitaux Universitaires De Strasbourg
Medecine Interne, Endocrinologie et Nutrition, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre du diabete DIAB-eCARE
N/A, 64 Avenue Rockefeller, Lyon, Lyon
Hôpital Côte de Nacre
Endocrinologie Diabetologie, Av. de la Côte de Nacre, 14300 Caen, Caen
Centre Hospitalier Sud Francilien
Endocrino diabétologie, 40 Avenue Serge Dassault, 91106, Corbeil Essonnes Cedex
CHU Rangueil
Diabetology - Metabolic diseases - Nutrition, 1 Avenue du Professeur Jean Poulhès, Toulouse, Toulouse
Centre De Recherche Clinique Portes Du Sud
Diabetology, 2 Avenue Du 11 Novembre 1918, 69200, Venissieux
Hopital NOVO
Endocrinology department, 6 Avenue De L Ile De France, 95300, Pontoise
Centre Hospitalier Universitaire De Nantes
CIC Endocrinology-Diabetology-Nutrition, Boulevard Du Professeur Jacques Monod, 44800, Saint Herblain
Universitaet Leipzig
Department Endokrinologie, Liebigstrasse 20, Zentrum-Suedost, Leipzig
MVZ DiaMedicum Bad Mergentheim GmbH
N/A, Theodor-Klotzbuecher-Strasse 12, 97980, Bad Mergentheim
Diabetes-Zentrum-Wilhelmsburg GbR
N/A, Krieterstrasse 30, Wilhelmsburg, Hamburg
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
N/A, Markt 15, 23758, Oldenburg In Holstein
Arztpraxis Christine Kosch Pirna
N/A, Königsteiner Strasse 6 b, Sachsen, Pirna
Diabetes- und Stoffwechselpraxis Bochum
N/A, In der Hönnebecke 80, 44869, Bochum
Diabetologikum DDG Ludwigshafe
N/A, Ludwigsplatz 9, 67059, Ludwigshafen
Institut fuer Diabetesforschung Muenster GmbH
N/A, Hohenzollernring 70, Herz-Jesu, Muenster
InnoDiab Forschung GmbH
N/A, Eleonorastrasse 42, Ruettenscheid, Essen
Klinikgruppe Dr. Guth GmbH & Co. KG
Klinik für Diabetes und Stoffwechselerkrankungen, Greifswalder Strasse 11, 17495, Karlsburg
Azienda Ospedaliera Universitaria Federico II Di Napoli
Dipartimento di Medicina Clinica e Chirurgia, Via Sergio Pansini 5, 80131, Naples
Azienda Ospedaliero Universitaria Careggi
Diabetologia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Universita Cattolica Del Sacro Cuore
UOSD Diabetologia, Largo Agostino Gemelli 8, 00168, Rome
Azienda Ospedaliera di Padova
UOC Malattie del Metabolismo, Via Nicolo' Giustiniani 2, 35128, Padova
Ospedale San Raffaele S.r.l.
" UO Medicina Generale a indirizzo Diabetologico e Endocrino-Metabolico", Via Olgettina 60, 20132, Milan
Azienda Ospedaliero Universitaria Renato Dulbecco
Malattie del Metabolismo, Viale Europa, 88100, Catanzaro
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Dipartimento di Scienze Mediche e Chirurgiche, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
SC Endocrinologia, Diabetologia e Metabolismo U, 14 Corso Achille Mario Dogliotti, 3° piano, Torino
Hospital De La Santa Creu I Sant Pau
Endocrinology and Nutrition, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitari Vall D Hebron
Endocrinology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
University Hospital Virgen Del Rocio S.L.
Endocrinology and Nutrition, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario De Mostoles
Endocrinology and Nutrition, Calle Rio Jucar S/N, 28935, Mostoles
Hospital Universitario Marques De Valdecilla
Endocrinology, Diabetes & Nutrition, Avenida Valdecilla Sn, 39008, Santander
Hospital Clinic De Barcelona
ICMDM - Clinical Institute of Digestive and Metabolic Diseases, Calle Villarroel 170, 08036, Barcelona
Complexo Hospitalario Universitario A Coruna
Endocrinology, Lugar Jubias De Arriba 84, 15006, A Coruna
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 |
|---|---|---|---|---|---|
| Denmark | 2025-06-23 | 2025-07-10 | 2025-12-12 | ||
| France | 2025-06-27 | 2025-07-01 | 2025-12-12 | ||
| Germany | 2025-06-23 | 2025-06-30 | 2025-12-12 | ||
| Italy | 2025-06-30 | 2025-07-16 | 2025-12-12 | ||
| Spain | 2025-06-25 | 2025-06-27 | 2025-12-12 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 91 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-519684-17-00_Redacted | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Copyright statement | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Hypoglycemic Events Diary-3_Translation Certificate | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Hypoglycemic Events Diary-4_Translation Certificate | 1.0 |
| Protocol (for publication) | D4_Patient facing documents_Study Medication Injection Diary_Simple_Translation Certificate | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Allocation | 1.0 |
| 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 Arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment materials_Trialbee Privacy Policy | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment materials_Trialbee_Digital Marketing Content | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment materials_Trialbee_Landing Page | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment materials_Trialbee_Overview Supplementary Information | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment materials_Trialbee_Secondary Assessment And Communication | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment materials_Trialbee_Self Assessment | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Procedure | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material Brochure_DA_DK_Redacted | 1.2 |
| Recruitment arrangements (for publication) | K2_Recruitment material Postcard Devices Video_DK-DA | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material Video Devices_DK-DA | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Brochure_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Brochure, Flyer, Poster and retention items Translation Certificate_Redacted | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Flyer_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Flyer_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Letter-Doctor-To-Patient_Master_Redacted | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Poster_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Material_Poster_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_SURPASS-T1D_Brochure_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_SURPASS-T1D_Flyer_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_SURPASS-T1D_Poster_Master | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee Digital Marketing Content | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee Landing Page | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee Overview Supplementary Information | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee Privacy Policy | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee Seconday Assessment And Communication | 2.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee Self Assessment | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Digital Marketing Content | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Landing Page | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Overview Supplementary Information | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Privacy Policy | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Secondary Assessment And Communication | 2 |
| Recruitment arrangements (for publication) | K2_Recruitment material_Trialbee_Self Assessment | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment_Brochure_Master_ES | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment_Flyer_Master_ES | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment_Letter-Doctor-To-Patient_Master_ES_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K2_Recruitment_Poster_Master_ES | 1.1 |
| Recruitment arrangements (for publication) | K3_Recruitment material Letter-Doctor-To-Patient_DA_DK_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K4_Recruitment material Flyer_DA_DK | 1.1 |
| Recruitment arrangements (for publication) | K5_Recruitment material Poster_DA_DK | 1.1 |
| Recruitment arrangements (for publication) | K7_Complete Consent Remote Consent Tracking QRG_Redacted | 4.1 |
| Recruitment arrangements (for publication) | K7_Complete Consent Security and Privacy Overview | 1.5 |
| Recruitment arrangements (for publication) | K7_eConsent Resource_Review Boards | 5.0 |
| Recruitment arrangements (for publication) | K7_eSignature In-Person Consent QRG | 7.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Addendum Genetic_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Main_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main - Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF for pregnant partner of study participant | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum ICF for study participant with pregnant partner | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Confidentiality Notice for TLC | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Confidentiality Notice Translation Certificate_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material IFU Tirzepatide Translation Certificate_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material IQVIA Complete Consent Participant-Facing Screenshots_Redacted | 1.4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Leaflet on trial subject rights | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Main ICF Translation Certificate_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material patient Card Translation Certificate_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Patient landing page_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Pregnant Participant ICF Translation Certificate_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Pregnant Partner ICF Translation Certificate_Redacted | 1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_eConsent Submission Letter | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IQVIA Complete Consent Security and Privacy QRG_Redacted | 1.5 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_IQVIA Privacy Policy eConsent | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Participant-Facing Screenshots_Redacted | 1.4 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient landing page_Redacted | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Study Participant Contact Card | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_TIRZEPATIDE-CT-IFU | 1 |
| Subject information and informed consent form (for publication) | L2_Other Subject Information_Country Patient Information Card | 1 |
| Subject information and informed consent form (for publication) | L3_Other subject information material Instructions For Use | 1.0 |
| Subject information and informed consent form (for publication) | L3_Other subject information material_IFU Tirzepatide | 1 |
| Subject information and informed consent form (for publication) | L3_Patient Cards | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ENG_2024-519684-17-00_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2024-519684-17-00_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2024-519684-17-00_Redacted | 1 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-13 | Denmark | Acceptable 2025-06-02
|
2025-06-02 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-06-05 | Acceptable 2025-06-02
|
2025-06-05 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-06-18 | Denmark | Acceptable 2025-06-02
|
2025-06-18 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-18 | Denmark | Acceptable 2025-09-19
|
2025-09-19 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-10-30 | Acceptable 2025-09-19
|
2025-10-30 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-26 | Denmark | Acceptable | 2025-12-19 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2026-02-20 | Acceptable | 2026-02-20 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-02-25 | Denmark | Acceptable | 2026-02-25 |