Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
390
Countries
8
Sites
37
Non-alcoholic steatohepatitis
1. To evaluate the effect of efinopegdutide versus placebo on the proportion of individuals with NASH resolution without worsening of fibrosis at Week 52. 2. To evaluate the safety and tolerability of efinopegdutide.
Key facts
- Sponsor
- Merck Sharp & Dohme LLC
- 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
- 1 Sep 2023 → 30 Dec 2025
- Decision date (initial)
- 2023-08-21
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Merck Sharp & Dohme LLC
External identifiers
- EU CT number
- 2022-502647-35-00
- WHO UTN
- U1111-1285-0933
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
1. To evaluate the effect of efinopegdutide versus placebo on the proportion of individuals with NASH resolution without worsening of fibrosis at Week 52.
2. To evaluate the safety and tolerability of efinopegdutide.
Secondary objectives 2
- To evaluate the effect of efinopegdutide versus placebo on the proportion of individuals with ≥1-stage improvement in fibrosis without worsening of steatohepatitis at Week 52.
- To evaluate the effect of efinopegdutide versus placebo on the mean percent change from baseline in body weight at Week 52.
Conditions and MedDRA coding
Non-alcoholic steatohepatitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 22.0 | PT | 10053219 | Non-alcoholic steatohepatitis | 100000004871 |
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
- Histologic confirmation of NASH based on liver biopsy. Histologic criteria for study entry include: • Nonalcoholic fatty liver disease (NAFLD) Activity Score ≥4 with a score ≥1 point in each component (steatosis, ballooning, and lobular inflammation), AND • NASH Clinical Research Network (CRN) fibrosis score indicative of Stage 2 or 3.
- No history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM controlled by diet or stable doses of antihyperglycemic agents (AHAs)
- Participants in South Korea are eligible between the ages of 19 to 80 years of age (inclusive)
Exclusion criteria 6
- History of liver disease other than NASH
- History or evidence of cirrhosis
- History of pancreatitis
- History of Type 1 Diabetes Mellitus (T1DM), diabetic ketoacidosis, or diabetes secondary to pancreatectomy
- History of bariatric surgery ≤5 years before study participation
- Has significant systemic or major illnesses, including recent events (≤6 months before study entry) of congestive heart failure, unstable angina, myocardial infarction, arterial revascularization, stroke, or transient ischemic attack
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis at Week 52
- Percentage of Participants Who Experienced an Adverse Event (AE)
- Percentage of Participants Who Discontinuing Study Medication Due to an AE
Secondary endpoints 2
- Percentage of Participants With ≥1 Stage Improvement in Fibrosis Without Worsening of Steatohepatitis At Week 52
- Change from Baseline in Body Weight At Week 52
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD9386877 · Product
- Active substance
- Efinopegdutide
- Substance synonyms
- HM12525A, HM-12525A, JNJ-64565111, MK-6024
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 5200 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10228843 · Product
- Active substance
- Efinopegdutide
- Substance synonyms
- HM12525A, HM-12525A, JNJ-64565111, MK-6024
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 5200 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10228842 · Product
- Active substance
- Efinopegdutide
- Substance synonyms
- HM12525A, HM-12525A, JNJ-64565111, MK-6024
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 5200 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
PRD10228841 · Product
- Active substance
- Efinopegdutide
- Substance synonyms
- HM12525A, HM-12525A, JNJ-64565111, MK-6024
- Pharmaceutical form
- SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 5200 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- MERCK & CO. INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 5
SUB32188 · Substance
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 2.4 mg milligram(s)
- Max total dose
- 124.8 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Discard secondary package, replace with clinical kit box. Overlabel primary container and clinical kit box with clinical labels. 1 pen per kit.
SUB32188 · Substance
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 2.4 mg milligram(s)
- Max total dose
- 124.8 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Discard secondary package, replace with clinical kit box. Overlabel primary container and clinical kit box with clinical labels. 1 pen per kit.
SUB32188 · Substance
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 2.4 mg milligram(s)
- Max total dose
- 124.8 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Discard secondary package, replace with clinical kit box. Overlabel primary container and clinical kit box with clinical labels. 1 pen per kit.
SUB32188 · Substance
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 2.4 mg milligram(s)
- Max total dose
- 124.8 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Discard secondary package, replace with clinical kit box. Overlabel primary container and clinical kit box with clinical labels. 1 pen per kit.
SUB32188 · Substance
- Active substance
- Semaglutide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 2.4 mg milligram(s)
- Max total dose
- 124.8 mg milligram(s)
- Max treatment duration
- 52 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Discard secondary package, replace with clinical kit box. Overlabel primary container and clinical kit box with clinical labels. 1 pen per kit.
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
Merck Sharp & Dohme LLC
- Sponsor organisation
- Merck Sharp & Dohme LLC
- Address
- 126 East Lincoln Avenue
- City
- Rahway
- Postcode
- 07065-4607
- Country
- United States
Scientific contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Ravi Shankar
Public contact point
- Organisation
- Merck Sharp & Dohme LLC
- Contact name
- Ravi Shankar
Third parties 12
| Organisation | City, country | Duties |
|---|---|---|
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| ICON Medical Imaging ORL-000001154
|
Blue Bell, United States | Other |
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | Other |
| AG Mednet Inc. ORG-100039869
|
Boston, United States | Other |
| Sampled (formerly Infinity Biologix) ORL-000000382
|
Piscataway, NJ, United States | Other |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Interactive response technologies (IRT) |
| Pharmaceutical Product Development LLC ORG-100016999
|
Richmond, United States | Other |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| AIT Bioscience, LLC ORL-000001146
|
Indianapolis, United States | Other |
| Echosens ORG-100045196
|
Paris, France | Other |
| QBIO ORL-000001155
|
Ithaca, United States | Other |
| Perceptive Eclinical Limited ORG-100041144
|
Nottingham, United Kingdom | Other |
Locations
8 EU/EEA countries · 37 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 4 | 2 |
| Belgium | Ended | 4 | 3 |
| Czechia | Ended | 4 | 3 |
| France | Ended | 9 | 7 |
| Hungary | Ended | 1 | 2 |
| Italy | Ended | 8 | 5 |
| Portugal | Ended | 7 | 4 |
| Spain | Ended | 30 | 11 |
| Rest of world
Singapore, Taiwan, China, South Africa, United Kingdom, Canada, Japan, Turkey, Korea, Democratic People's Republic of, Hong Kong, Israel, Colombia, Puerto Rico, Chile, Mexico, Peru, Thailand, United States, Switzerland
|
— | 323 | — |
Investigational sites
Medical University Of Graz
Division of Gastroenterology and Hepatology, Neue Stiftingtalstrasse 6, 8010, Graz
Klinik Landstrabe
Department of Internal Medicine I with Diabetology, Endocrinology and Nephrology, Juchgasse 25, Landstrasse, Vienna
Az Maria Middelares Gent
digestif center, Buitenring-Sint-Denijs 30, 9000, Gent
Antwerp University Hospital
Gastro-enterology and hepatology department, Drie Eikenstraat 655, 2650, Edegem
UZ Leuven
Gastro-enterology and hepatology department, Herestraat 49, 3000, Leuven
Klin Med s.r.o.
Klin Med s.r.o., Jugoslavska 567/16, Vinohrady, Prague 2
Vseobecna Fakultni Nemocnice V Praze
IV. Interní klinika – klinika gastroenterologie a hepatologie, U Nemocnice 499/2, Nove Mesto, Prague 2
Krajska nemocnice Liberec a.s.
Oddělení gastroenterologie a hepatologie, Husova 1430/34, 460 01, Liberec I-Stare Mesto
Assistance Publique Hopitaux De Paris
Hepato-Gastroenterology Department, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Centre Hospitalier Lyon Sud
Service of Endocrinology, Diabetes and Nutrition, Chemin Du Grand Revoyet, 69310, Pierre Benite
Assistance Publique Hopitaux De Paris
Hepatology, 27 Rue Du Faubourg Saint Jacques, 75014, Paris
CHU De Rouen
Hepato-Gastroenterology Department, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Hospitalier Universitaire De Nice
Hepato-Gastroenterology Department, 151 Route De Saint Antoine, 06200, Nice
Centre Hospitalier Universitaire De Bordeaux
Hepato-Gastroenterology, Avenue De Magellan, 33600, Pessac
Hopital De La Croix Rousse
Hepato-Gastroenterology Department, 103 Grande Rue De La Croix Rousse, 69317, Lyon Cedex 04
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Hepatologia Szakrendelo, Albert Florian Ut 5-7, 1097, Budapest IX
SYNEXUS Magyarorszag Kft.
NA, Becsi Ut 61, 1036, Budapest III
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Sc Medicina – Indirizzo Metabolico, Via Francesco Sforza 35, 20122, Milan
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
UOC di Gastroenterologia ed Epatologia, Via Del Vespro 129, 90127, Palermo
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Dipartimento di Medicina Interna e Gastroenterologia, Largo Francesco Vito 1, 00168, Rome
Humanitas Research Hospital
Medicina Interna ed Epatologia, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
S.C. Gastroenterologia U. - DH piano terra, Corso Bramante 88, 10126, Turin
Unidade Local De Saude De Santa Maria E.P.E.
Service of Gastroenterology and Hepatology, Avenida Professor Egas Moniz, 1649-035, Lisbon
Unidade Local De Saude Lisboa Ocidental E.P.E.
Service of Gastroenterology, Rua Da Junqueira 126, 1349-019, Lisbon
Unidade Local De Saude Do Alto Minho E.P.E.
Service of Gastroenterology, Estrada De Santa Luzia, 4904-858, Viana Do Castelo
Unidade Local De Saude Do Alto Ave E.P.E.
Service of Internal Medicine, Rua Dos Cuteleiros De Guimaraes, 4835-044, Guimaraes
Hospital Universitario Puerta De Hierro De Majadahonda
Gastroenterología and Hepatology, Calle De Joaquin Rodrigo 2, 28222, Majadahonda
Complexo Hospitalario Universitario A Coruna
Servicio de Endocrinología, Lugar Jubias De Arriba 84, 15006, A Coruna
Hospital Universitario Virgen De La Victoria
UGC Endocrinologia y nutricion, Calle Del Arroyo Teatinos S N, 29010, Malaga
Complexo Hospitalario Universitario De Santiago
Servicio de Hepatología, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitari Vall D Hebron
Liver Unit, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario La Paz
Servicio de Gastroenterologia y Hepatologia, Paseo Castellana 261, 28046, Madrid
Hospital Unviersitario Miguel Servet
Servicio Gastroenterologia, Paseo De Isabel La Catolica 1-3, 50009, Zaragoza
University Hospital Virgen Del Rocio S.L.
Servicio de Hepatología, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital General De Tomelloso
Servicio de Gastroenterología y Hepatología, Vereda De Socuellamos S/n, 13700, Tomelloso
Hospital Universitario Ramon Y Cajal
Servicio de Gastroenterología y Hepatología, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Marques De Valdecilla
Gastroenterologia y Hepatologia, 5 Planta, Avenida Valdecilla S/n, Santander
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 |
|---|---|---|---|---|---|
| Austria | 2024-01-11 | 2024-08-19 | 2024-03-15 | 2024-08-19 | |
| Belgium | 2023-10-25 | 2025-10-28 | 2023-11-17 | 2024-08-19 | |
| Czechia | 2023-11-28 | 2025-12-17 | 2024-03-20 | 2024-08-19 | |
| France | 2023-10-04 | 2025-11-20 | 2023-10-30 | 2024-08-19 | |
| Hungary | 2023-10-18 | 2025-07-31 | 2023-10-31 | 2024-08-19 | |
| Italy | 2023-10-03 | 2025-12-29 | 2023-10-30 | 2024-08-19 | |
| Portugal | 2023-11-02 | 2025-12-03 | 2023-11-27 | 2024-08-19 | |
| Spain | 2023-09-01 | 2025-11-28 | 2023-09-08 | 2024-08-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 107 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2022-502647-35_SM07_for pub | 05R |
| Protocol (for publication) | D4_Copyright Statement_SM07_for pub | 04DEC2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_BEL_EN_for pub | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_CZE_CS_for pub | 12APR2023 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_FRA_FR_for pub | 03APR2024 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_HUN_EN_for pub | 05APR2023 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and IC Procedure_PRT_EN_for pub | 4-0 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_ESP_ES_for pub | 28MAR2023 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements_ITA_EN_for pub | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment Doc Healthcare Provider_ESP_ES_NSM04_for pub | 1-0 |
| Recruitment arrangements (for publication) | K1_Recruitment Doc Physitian letter_ESP_ES_NSM04_for pub | 1-0 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Healthcare Provider_CZE_CS_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_CZE_CS_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Master Tissue Brochure_PRT_PT_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Banner Ad_FRA_FR_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_BEL_EN_for pub | v1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_BEL_FR_for pub | v1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_BEL_NL_for pub | v1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_CZE_CS_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_ESP_ES_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_FRA_FR_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_Liver Biopsy_ESP_ES_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Brochure_PRT_PT_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Flyer_CZE_CS_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Flyer_ESP_ES_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Letter_ESP_ES_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Print Ad_FRA_FR_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_BEL_EN_for pub | v1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_BEL_FR_for pub | v1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_BEL_NL_for pub | v1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_CZE_CS_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Patient Visit Guide_PRT_PT_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Poster_CZE_CS_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Study Card_CZE_CS_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Website_BEL_EN_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Website_BEL_FR_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Website_BEL_NL_for pub | 1 |
| Recruitment arrangements (for publication) | K2_Recruitment Doc Website_FRA_FR_for pub | 1 |
| Subject information and informed consent form (for publication) | L1_Glucometer user manual_CZE_CS_for pub | IMC00558 |
| Subject information and informed consent form (for publication) | L1_ICF_Associated Person_Privacy_ITA_IT_for pub | 26MAR2024 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_BEL_EN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_BEL_FR_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_BEL_NL_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_CZE_CS_for pub | v0-00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_ESP_ES_for pub | ESP_v01 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_FRA_FR_for pub | 0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_FRA_UR_for pub | 0.00R |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_HUN_HU_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR consent_ITA_IT_for pub | 0.00 |
| Subject information and informed consent form (for publication) | L1_ICF_FBR data privacy_ITA_IT_for pub | 04APR2023 |
| Subject information and informed consent form (for publication) | L1_ICF_Genetic consent_HUN_HU_for pub | v0-00 |
| Subject information and informed consent form (for publication) | L1_ICF_Genetic consent_PRT_PT_for pub | 01 |
| Subject information and informed consent form (for publication) | L1_ICF_Main addendum_FRA_FR_SM06_for pub | AM03v3.0 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_BEL_EN_SM06_for pub | AM02v2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_BEL_FR_SM06_for pub | AM02v2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_BEL_NL_SM06_for pub | AM02v2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_CZE_CS_SM06_for pub | Czech v3R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ESP_ES_SM06_for pub | AM02v2.00R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FRA_FR_for pub | AM02v2.0R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_FRA_UR_for pub | AM02v2.0R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_HUN_HU_SM06_for pub | AM02v2.0R |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_ITA_IT_SM06_for pub | AM02v2.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main consent_PRT_PT_SM06_for pub | AM02v2.00 |
| Subject information and informed consent form (for publication) | L1_ICF_Main data privacy_ITA_IT_for pub | 04APR2023 |
| Subject information and informed consent form (for publication) | L1_ICF_Main GDPR_CZE_CS_for pub | v3-0 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_associated person_ESP_ES_SM06_for pub | 00R |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_DILI sample_ITA_IT_for pub | 04APR2023 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adult_PRT_PT_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_BEL_EN_SM07_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_BEL_FR_SM07_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_Greenphire adults_BEL_NL_SM07_for pub | 0.01 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_ESP_ES_SM07_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_pregnancy follow-up_PRT_PT_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_trial at a glance_BEL_EN_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_trial at a glance_BEL_FR_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_ICF_Optional_trial at a glance_BEL_NL_for pub | 00 |
| Subject information and informed consent form (for publication) | L1_Injection diary_CZE_CS_Part 1_for pub | 2-0_00_1-0 |
| Subject information and informed consent form (for publication) | L1_Injection diary_CZE_CS_Part 2_for pub | 1-0_00_1-0 |
| Subject information and informed consent form (for publication) | L1_Injection diary_CZE_CS_Part 3_for pub | 1-0_00_1-0 |
| Subject information and informed consent form (for publication) | L1_Injection diary_CZE_CS_Part 4_for pub | 1-0_00_1-0 |
| Subject information and informed consent form (for publication) | L1_Injection diary_CZE_CS_Part 5_for pub | 1-0_00_1-0 |
| Subject information and informed consent form (for publication) | L1_Injection diary_CZE_CS_Part 6_for pub | 1-0_00_1-0 |
| Subject information and informed consent form (for publication) | L1_Patient handout_CZE_CS_for pub | 2-0 |
| Subject information and informed consent form (for publication) | L1_Patient ID Card_CZE_CS_for pub | 1.0_00_1.2 |
| Subject information and informed consent form (for publication) | L1_Patient ID Card_HUN_HU_for pub | 1-0 |
| Subject information and informed consent form (for publication) | L1_Patient injection diary_ Part 1_CZE_CS_for pub | Part 1_v2 |
| Subject information and informed consent form (for publication) | L1_Patient injection diary_Part 2_CZE_CS_for pub | Part 2_v2 |
| Subject information and informed consent form (for publication) | L1_Patient injection diary_Part 3_CZE_CS_for pub | Part 3_v2 |
| Subject information and informed consent form (for publication) | L1_Patient injection diary_Part 4_CZE_CS_for pub | Part 4_v2 |
| Subject information and informed consent form (for publication) | L1_Patient injection diary_Part 5_CZE_CS_for pub | Part 5_v2 |
| Subject information and informed consent form (for publication) | L1_Patient injection diary_Part 6_CZE_CS_for pub | Part 6_v2_ |
| Subject information and informed consent form (for publication) | L1_Patient instructions_CZE_CS_for pub | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC RSI_Semaglutide_Novo Nordisk_SM11_for pub | 02OCT2024 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC RSI_Semaglutide_Novo Nordisk_for pub | 09APR2021 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-502647_FRA_FR_SM06_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-502647-35_BEL_DE_SM06_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-502647-35_BEL_FR_SM06_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-502647-35_BEL_NL_SM06_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-502647-35_CZE_CS_SM06_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-502647-35_HUN_HU_SM06_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-502647-35_ITA_IT_SM06_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-502647-35_PRT_PT_SM06_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-502647-35_SM06_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_2022-502647-35-00_ESP_ES_SM06_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_PPLS_AUT_DE_ 2022-502647-35_for pub | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2022-502647-35_CZE_CS_SM06_for pub | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Scientific Synopsis_2022-502647-35-00_AUT_DE_for pub | 03 |
Application history
13 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-24 | Czechia | Acceptable with conditions 2023-08-21
|
2023-08-21 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2023-08-22 | Acceptable with conditions 2023-08-21
|
2023-08-22 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2023-09-14 | Czechia | Acceptable with conditions 2023-08-21
|
2023-09-14 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2023-09-14 | Czechia | Acceptable with conditions 2023-08-21
|
2023-09-14 |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-13 | Czechia | Acceptable 2023-12-13
|
2023-12-14 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-02-08 | Acceptable | 2024-03-13 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-04-12 | Czechia | Acceptable 2024-06-13
|
2024-06-13 |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-07-18 | Czechia | Acceptable 2024-10-09
|
2024-10-09 |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-12-06 | Czechia | Acceptable with conditions 2025-03-07
|
2025-03-07 |
| 10 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-03-27 | Czechia | Acceptable with conditions 2025-07-07
|
2025-07-07 |
| 11 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-07-11 | Acceptable with conditions | 2025-07-23 | |
| 12 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-09-18 | Czechia | Acceptable 2025-11-20
|
2025-11-20 |
| 13 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-12-10 | Acceptable 2025-11-20
|
2025-12-10 |