Clinical trial • Phase III • Endocrinology
CAGRILINTIDE, SEMAGLUTIDE for Type 2 diabetes
Phase III trial of CAGRILINTIDE, SEMAGLUTIDE for Type 2 diabetes.
Overview
- Trial Therapeutic Area
- Endocrinology
- Trial Disease
- Type 2 diabetes
- Trial Stage
- Phase III
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 26-04-2024
- First CTIS Authorization Date
- 20-08-2024
Trial design
tirzepatide (Mounjaro) 5 mg subcutaneous once weekly (Mounjaro 5 mg solution for injection in pre-filled pen) (trial comparator as stated in title).-controlled Phase III trial in Poland, Romania, Greece and others.
- Comparator
- tirzepatide (Mounjaro) 5 mg subcutaneous once weekly (Mounjaro 5 mg solution for injection in pre-filled pen) (trial comparator as stated in title).
- Target Sample Size
- 590
- Trial Duration For Participant
- 420
Eligibility
Recruits 590 No vulnerable populations selected. Participants must be adults (Age 18 years or above) and provide informed consent; assent for minors is not applicable and not specified..
- Pregnancy Exclusion
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
- Vulnerable Population
- No vulnerable populations selected. Participants must be adults (Age 18 years or above) and provide informed consent; assent for minors is not applicable and not specified.
Inclusion criteria
- {"criterion_text":"- Male or female."}
- {"criterion_text":"- Age 18 years or above at the time of signing the informed consent."}
- {"criterion_text":"- Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening."}
- {"criterion_text":"- HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening."}
- {"criterion_text":"- BMI ≥ 30 kg/m2 at screening. BMI will be calculated in the eCRF based on height and body weight at screening."}
- {"criterion_text":"- Stable daily dose(s) ≥ 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: - Metformin - SGLT2 inhibitor"}
Exclusion criteria
- {"criterion_text":"- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method."}
- {"criterion_text":"- Renal impairment with estimated Glomerular Filtration Rate < 30 ml/min/1.73 m2 as determined by central laboratory at screening."}
- {"criterion_text":"- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination."}
- {"criterion_text":"- Treatment with any anti-diabetic or anti-obesity medication (irrespective of indication) other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days is allowed."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change in HbA1c from baseline (week 0) to end of treatment (week 60)","definition_or_measurement_approach":"Change from baseline (week 0) to week 60; HbA1c measured as per central laboratory procedures (baseline determination noted as by central laboratory at screening)."}
- {"endpoint_text":"- Relative change in body weight from baseline (week 0) to end of treatment (week 60)","definition_or_measurement_approach":"Relative change in body weight from baseline (week 0) to week 60 (percentage change from baseline)."}
Secondary endpoints
- {"endpoint_text":"- Superiority of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Change in HbA1c from baseline (week 0) to end of treatment (week 60)","definition_or_measurement_approach":"Change from baseline (week 0) to week 60."}
- {"endpoint_text":"- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Change in FPG from baseline (week 0) to end of treatment (week 60)","definition_or_measurement_approach":"Change in fasting plasma glucose (FPG) from baseline to week 60."}
- {"endpoint_text":"- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Achievement of HbA1c target values of ≤6.5% (≤48 mmol/mol) at the end of treatment (week 60)","definition_or_measurement_approach":"Proportion achieving HbA1c ≤6.5% at week 60."}
- {"endpoint_text":"- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Achievement of HbA1c target values of <7.0% (<53 mmol/mol) at the end of treatment (week 60)","definition_or_measurement_approach":"Proportion achieving HbA1c <7.0% at week 60."}
- {"endpoint_text":"- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Achievement of ≥ 10% weight reduction from baseline (week 0) to end of treatment (week 60)","definition_or_measurement_approach":"Proportion of participants with ≥10% weight reduction from baseline to week 60."}
- {"endpoint_text":"- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Achievement of ≥ 5% weight reduction from baseline (week 0) to end of treatment (week 60)","definition_or_measurement_approach":"Proportion of participants with ≥5% weight reduction from baseline to week 60."}
- {"endpoint_text":"- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Achievement of ≥ 15% weight reduction from baseline (week 0) to end of treatment (week 60)","definition_or_measurement_approach":"Proportion of participants with ≥15% weight reduction from baseline to week 60."}
- {"endpoint_text":"- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Achievement of ≥ 20% weight reduction from baseline (week 0) to end of treatment (week 60)","definition_or_measurement_approach":"Proportion of participants with ≥20% weight reduction from baseline to week 60."}
- {"endpoint_text":"- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Change in systolic blood pressure from baseline (week 0) to end of treatment (week 60)","definition_or_measurement_approach":"Change in systolic blood pressure from baseline to week 60."}
- {"endpoint_text":"- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Change in diastolic blood pressure from baseline (week 0) to end of treatment (week 60)","definition_or_measurement_approach":"Change in diastolic blood pressure from baseline to week 60."}
- {"endpoint_text":"- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Change in waist circumference from baseline (week 0) to end of treatment (week 60)","definition_or_measurement_approach":"Change in waist circumference from baseline to week 60."}
- {"endpoint_text":"- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Ratio to baseline in lipids from baseline (week 0) to end of treatment (week 60): •\tTotal cholesterol •\tHDL cholesterol •\tLDL cholesterol •\tVLDL cholesterol •\tTriglycerides •\tNon-HDL cholesterol","definition_or_measurement_approach":"Ratios/changes from baseline to week 60 for listed lipid parameters."}
- {"endpoint_text":"- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Change in SF-36v2 score from baseline (week 0) to end of treatment (week 60): •\tPhysical Component Summary score •\tMental Component Summary score •\tVitality subscale","definition_or_measurement_approach":"Change from baseline to week 60 in SF-36v2 summary and vitality subscale scores."}
- {"endpoint_text":"- Effect of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Change in IWQOL-Lite-CT from baseline (week 0) to end of treatment (week 60): •\tPhysical Function score •\tTotal score","definition_or_measurement_approach":"Change from baseline to week 60 in IWQOL-Lite-CT scores."}
- {"endpoint_text":"- Safety and tolerability of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Number of TEAEs from baseline (week 0) to end of treatment (week 60)","definition_or_measurement_approach":"Number of treatment-emergent adverse events from baseline to week 60."}
- {"endpoint_text":"- Safety and tolerability of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (<54 mg/dL), confirmed by BG meter) from baseline (week 0) to end of treatment (week 60)","definition_or_measurement_approach":"Number of clinically significant (level 2) hypoglycaemic episodes confirmed by BG meter from baseline to week 60."}
- {"endpoint_text":"- Safety and tolerability of CagriSema 00 mg/00 mg versus tirzepatide 5 mg: Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold from baseline (week 0) to end of treatment (week 60)","definition_or_measurement_approach":"Number of severe (level 3) hypoglycaemic episodes requiring external assistance from baseline to week 60."}
Recruitment
- Planned Sample Size
- 590
- Recruitment Window Months
- 21
- Consent Approach
- Informed consent to be obtained from adult participants (age 18+). Country-specific subject information and informed consent forms are provided (documents present for PL, RO, GR, DE, HU, ES and English versions). No assent for minors is applicable.
Geography
- Total Number Of Sites
- 50
- Total Number Of Participants
- 410
Poland
- Earliest CTIS Part Ii Submission Date
- 19-07-2024
- Latest Decision Or Authorization Date
- 03-04-2026
- Processing Time Days
- 623
- Number Of Sites
- 9
- Number Of Participants
- 80
Sites
- Site Name
- Uniwersytecki Szpital Kliniczny W Bialymstoku
- Principal Investigator Name
- Adam Kretowski
- Principal Investigator Email
- adam.kretowski@umb.edu.pl
- Contact Person Name
- Adam Kretowski
- Contact Person Email
- adam.kretowski@umb.edu.pl
- Site Name
- Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
- Principal Investigator Name
- Malgorzata Jozefowska
- Principal Investigator Email
- m.jozefowska@ctw.com.pl
- Contact Person Name
- Malgorzata Jozefowska
- Contact Person Email
- m.jozefowska@ctw.com.pl
- Site Name
- Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
- Principal Investigator Name
- Radoslaw Rumianowski
- Principal Investigator Email
- radrum@mp.pl
- Contact Person Name
- Radoslaw Rumianowski
- Contact Person Email
- radrum@mp.pl
- Site Name
- Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach
- Principal Investigator Name
- Janusz Marek Gumprecht
- Principal Investigator Email
- jgumprecht@sum.edu.pl
- Contact Person Name
- Janusz Marek Gumprecht
- Contact Person Email
- jgumprecht@sum.edu.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Bialymstoku
- Department Name
- Centrum Badań Klinicznych
- Principal Investigator Name
- Irina Kowalska
- Principal Investigator Email
- metaboliczne@umb.edu.pl
- Contact Person Name
- Irina Kowalska
- Contact Person Email
- metaboliczne@umb.edu.pl
- Site Name
- Centrum Medyczne Oporow
- Principal Investigator Name
- Katarzyna Madziarska
- Principal Investigator Email
- katarzyna.madziarska@cmoporow.com
- Contact Person Name
- Katarzyna Madziarska
- Contact Person Email
- katarzyna.madziarska@cmoporow.com
- Site Name
- Kiepury Clinic MALGORZATA JARNOT Specjalistyczna Praktyka Ginekologiczno-Poloznicza
- Principal Investigator Name
- Wojciech Jablonski
- Principal Investigator Email
- apfel@poczta.onet.pl
- Contact Person Name
- Wojciech Jablonski
- Contact Person Email
- apfel@poczta.onet.pl
- Site Name
- Diab Serwis Popenda Sp. j.
- Principal Investigator Name
- Grazyna Popenda
- Principal Investigator Email
- przychodnia@pozserwis.com.pl
- Contact Person Name
- Grazyna Popenda
- Contact Person Email
- przychodnia@pozserwis.com.pl
- Site Name
- Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
- Principal Investigator Name
- Ewa Steckiewicz
- Principal Investigator Email
- ewasteckiewicz@etykaosrodek.pl
- Contact Person Name
- Ewa Steckiewicz
- Contact Person Email
- ewasteckiewicz@etykaosrodek.pl
Romania
- Earliest CTIS Part Ii Submission Date
- 13-08-2024
- Latest Decision Or Authorization Date
- 06-04-2026
- Processing Time Days
- 601
- Number Of Sites
- 9
- Number Of Participants
- 70
Sites
- Site Name
- Mediab S.R.L.
- Department Name
- Diabet
- Principal Investigator Name
- Mirela Suciu
- Principal Investigator Email
- o_mirela2001@yahoo.com
- Contact Person Name
- Mirela Suciu
- Contact Person Email
- o_mirela2001@yahoo.com
- Site Name
- Cabinet Medical Individual Diabet, Nutritie, Boli Metabolice Dr. Pop Lavinia
- Department Name
- Diabet
- Principal Investigator Name
- Lavinia Pop
- Principal Investigator Email
- laviniapop10@yahoo.com
- Contact Person Name
- Lavinia Pop
- Contact Person Email
- laviniapop10@yahoo.com
- Site Name
- Nutrilife S.R.L.
- Department Name
- Diabet
- Principal Investigator Name
- Marlena Pascu
- Principal Investigator Email
- marlena.pascu@nutrilife.ro
- Contact Person Name
- Marlena Pascu
- Contact Person Email
- marlena.pascu@nutrilife.ro
- Site Name
- Diabdana S.R.L.
- Department Name
- Diabet
- Principal Investigator Name
- Dana Cosma
- Principal Investigator Email
- dana_cosma_oradea@yahoo.com
- Contact Person Name
- Dana Cosma
- Contact Person Email
- dana_cosma_oradea@yahoo.com
- Site Name
- Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti
- Department Name
- Clinica Diabet I
- Principal Investigator Name
- Cornelia Zetu
- Principal Investigator Email
- corapnc@yahoo.com
- Contact Person Name
- Cornelia Zetu
- Contact Person Email
- corapnc@yahoo.com
- Site Name
- Clinica Korall S.R.L.
- Department Name
- Diabet
- Principal Investigator Name
- Adriana Filimon
- Principal Investigator Email
- adriana_teaca@yahoo.com
- Contact Person Name
- Adriana Filimon
- Contact Person Email
- adriana_teaca@yahoo.com
- Site Name
- Diabet Med S.R.L.
- Department Name
- Diabet
- Principal Investigator Name
- Daniela Strajer
- Principal Investigator Email
- diabetmedstudy@gmail.com
- Contact Person Name
- Daniela Strajer
- Contact Person Email
- diabetmedstudy@gmail.com
- Site Name
- Sanamed Hospital S.R.L.
- Department Name
- Diabet
- Principal Investigator Name
- Andra Ianculescu
- Principal Investigator Email
- andra.liana@gmail.com
- Contact Person Name
- Andra Ianculescu
- Contact Person Email
- andra.liana@gmail.com
- Site Name
- Mediab S.R.L.
- Department Name
- Diabet
- Principal Investigator Name
- Carmen Crisan
- Principal Investigator Email
- carmenicrisan@yahoo.com
- Contact Person Name
- Carmen Crisan
- Contact Person Email
- carmenicrisan@yahoo.com
Greece
- Earliest CTIS Part Ii Submission Date
- 13-05-2024
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 687
- Number Of Sites
- 8
- Number Of Participants
- 80
Sites
- Site Name
- Laiko General Hospital Of Athens
- Department Name
- 1st Dpt. of Propadeutic Internal Medicine
- Principal Investigator Name
- Alexandros Kokkinos
- Principal Investigator Email
- rjd@otenet.gr
- Contact Person Name
- Alexandros Kokkinos
- Contact Person Email
- rjd@otenet.gr
- Site Name
- Athens Medical Center S.A.
- Department Name
- Diabetes Department and Clinical Research Center
- Principal Investigator Name
- John Doupis
- Principal Investigator Email
- john.doupis@harvard-alumni.org
- Contact Person Name
- John Doupis
- Contact Person Email
- john.doupis@harvard-alumni.org
- Site Name
- General Hospital Venizeleio
- Department Name
- Diabetic clinic
- Principal Investigator Name
- Efthymia Mandalaki
- Principal Investigator Email
- efimanda@gmail.com
- Contact Person Name
- Efthymia Mandalaki
- Contact Person Email
- efimanda@gmail.com
- Site Name
- Alexandra Hospital
- Department Name
- Therapeutic Clinic
- Principal Investigator Name
- Theodora Psaltopoulou
- Principal Investigator Email
- tpsaltop@hotmail.com
- Contact Person Name
- Theodora Psaltopoulou
- Contact Person Email
- tpsaltop@hotmail.com
- Site Name
- General Hospital Of Thessloniki G Gennimatas
- Department Name
- Internal Medicine Clinic
- Principal Investigator Name
- Ioannis Stergiou
- Principal Investigator Email
- iostergiou@yahoo.gr
- Contact Person Name
- Ioannis Stergiou
- Contact Person Email
- iostergiou@yahoo.gr
- Site Name
- Ippokratio General Hospital Of Thessaloniki
- Department Name
- 2nd Medical Department
- Principal Investigator Name
- Aris Liakos
- Principal Investigator Email
- arliakos@auth.gr
- Contact Person Name
- Aris Liakos
- Contact Person Email
- arliakos@auth.gr
- Site Name
- University General Hospital Of Ioannina
- Department Name
- Internal Medicine
- Principal Investigator Name
- Vasileios Tsimichodimos
- Principal Investigator Email
- vtsimi@uoi.gr
- Contact Person Name
- Vasileios Tsimichodimos
- Contact Person Email
- vtsimi@uoi.gr
- Site Name
- Evangelismos S.A.
- Department Name
- Department of Endocrinology
- Principal Investigator Name
- Theodora Stratigou
- Principal Investigator Email
- theodorastratigou@yahoo.gr
- Contact Person Name
- Theodora Stratigou
- Contact Person Email
- theodorastratigou@yahoo.gr
Germany
- Earliest CTIS Part Ii Submission Date
- 13-05-2024
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 687
- Number Of Sites
- 8
- Number Of Participants
- 60
Sites
- Site Name
- Zentrum für klinische Forschung Allgäu Oberschwaben
- Principal Investigator Name
- Joachim Sauter
- Principal Investigator Email
- joachim@dr-sauter-wangen.de
- Contact Person Name
- Joachim Sauter
- Contact Person Email
- joachim@dr-sauter-wangen.de
- Site Name
- Praxis am Markt Dr. Becker
- Principal Investigator Name
- Bernd Becker
- Principal Investigator Email
- dr.b.becker-essen@t-online.de
- Contact Person Name
- Bernd Becker
- Contact Person Email
- dr.b.becker-essen@t-online.de
- Site Name
- Wendisch/Dahl Hamburg
- Principal Investigator Name
- Dominik Dahl
- Principal Investigator Email
- dr.dahl@dzhw.de
- Contact Person Name
- Dominik Dahl
- Contact Person Email
- dr.dahl@dzhw.de
- Site Name
- Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
- Principal Investigator Name
- Susanne Reger-Tan
- Principal Investigator Email
- sreger-tan@hdz-nrw.de
- Contact Person Name
- Susanne Reger-Tan
- Contact Person Email
- sreger-tan@hdz-nrw.de
- Site Name
- Medicover Neuroendokrinologie MVZ
- Principal Investigator Name
- Günter K Stalla
- Principal Investigator Email
- guenter.stalla@medicover.de
- Contact Person Name
- Günter K Stalla
- Contact Person Email
- guenter.stalla@medicover.de
- Site Name
- Medical Center - University Of Freiburg
- Principal Investigator Name
- Jochen Seufert
- Principal Investigator Email
- jochen.seufert@uniklinik-freiburg.de
- Contact Person Name
- Jochen Seufert
- Contact Person Email
- jochen.seufert@uniklinik-freiburg.de
- Site Name
- Schwerpunktpraxis für Diabetes und Ernährungsmedizin
- Principal Investigator Name
- Winfried Keuthage
- Principal Investigator Email
- keuthage@diabetes-praxis-muenster.de
- Contact Person Name
- Winfried Keuthage
- Contact Person Email
- keuthage@diabetes-praxis-muenster.de
- Site Name
- Universitaetsklinikum Essen AöR
- Principal Investigator Name
- Annie Mathew
- Principal Investigator Email
- Annie.Mathew@uk-essen.de
- Contact Person Name
- Annie Mathew
- Contact Person Email
- Annie.Mathew@uk-essen.de
Hungary
- Earliest CTIS Part Ii Submission Date
- 25-06-2024
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 685
- Number Of Sites
- 10
- Number Of Participants
- 70
Sites
- Site Name
- PVN Kutato Kft.
- Principal Investigator Name
- Judit Nádas
- Principal Investigator Email
- nadasjudit@gmail.com
- Contact Person Name
- Judit Nádas
- Contact Person Email
- nadasjudit@gmail.com
- Site Name
- Qualiclinic Kft.
- Principal Investigator Name
- Janos Tibor Kis
- Principal Investigator Email
- kis.janos.tibor.dr@gmail.com
- Contact Person Name
- Janos Tibor Kis
- Contact Person Email
- kis.janos.tibor.dr@gmail.com
- Site Name
- Komaromi Selye Janos Korhaz
- Department Name
- Belgyogyaszati szakrendeles
- Principal Investigator Name
- Katalin Revesz
- Principal Investigator Email
- reveszkati62@gmail.com
- Contact Person Name
- Katalin Revesz
- Contact Person Email
- reveszkati62@gmail.com
- Site Name
- Obudai Egeszseguegyi Centrum Kft.
- Principal Investigator Name
- Viktor Vass
- Principal Investigator Email
- vassviktor@yahoo.com
- Contact Person Name
- Viktor Vass
- Contact Person Email
- vassviktor@yahoo.com
- Site Name
- ClinDiab Kft.
- Principal Investigator Name
- Krisztina Wudi
- Principal Investigator Email
- krisztina.wudi@clindiab.hu
- Contact Person Name
- Krisztina Wudi
- Contact Person Email
- krisztina.wudi@clindiab.hu
- Site Name
- Med-Tima Kft.
- Principal Investigator Name
- Tímea Tanczer
- Principal Investigator Email
- tantim@t-online.hu
- Contact Person Name
- Tímea Tanczer
- Contact Person Email
- tantim@t-online.hu
- Site Name
- Semmelweis University
- Department Name
- Department of Internal Medicine and Oncology
- Principal Investigator Name
- Győző Kocsis
- Principal Investigator Email
- kocsis.gyozo@semmelweis.hu
- Contact Person Name
- Győző Kocsis
- Contact Person Email
- kocsis.gyozo@semmelweis.hu
- Site Name
- Szocs Depot Egeszsegugyi Szolgaltato Kft.
- Principal Investigator Name
- Albert Szocs
- Principal Investigator Email
- drszocsalbert@gmail.com
- Contact Person Name
- Albert Szocs
- Contact Person Email
- drszocsalbert@gmail.com
- Site Name
- Central Hospital Of Northern Pest Military Hospital
- Department Name
- Diabetology
- Principal Investigator Name
- Judit Hevesi
- Principal Investigator Email
- hevesi.judit0607@gmail.com
- Contact Person Name
- Judit Hevesi
- Contact Person Email
- hevesi.judit0607@gmail.com
- Site Name
- University Of Szeged
- Department Name
- 1st Department of Internal Medicine
- Principal Investigator Name
- Róbert Takács
- Principal Investigator Email
- takacs.robert@med.u-szeged.hu
- Contact Person Name
- Róbert Takács
- Contact Person Email
- takacs.robert@med.u-szeged.hu
Spain
- Earliest CTIS Part Ii Submission Date
- 11-06-2024
- Latest Decision Or Authorization Date
- 01-04-2026
- Processing Time Days
- 659
- Number Of Sites
- 6
- Number Of Participants
- 50
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Principal Investigator Name
- Andreea Ciudin
- Principal Investigator Email
- andreea.ciudin@vallhebron.cat
- Contact Person Name
- Andreea Ciudin
- Contact Person Email
- andreea.ciudin@vallhebron.cat
- Site Name
- Centro Periferico De Especialidades Bola Azul
- Principal Investigator Name
- Pedro Mezquita Raya
- Principal Investigator Email
- pmr.hut@gmail.com
- Contact Person Name
- Pedro Mezquita Raya
- Contact Person Email
- pmr.hut@gmail.com
- Site Name
- Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
- Principal Investigator Name
- Alberto Aliaga Verdugo
- Principal Investigator Email
- a.aliaga@ntde.es
- Contact Person Name
- Alberto Aliaga Verdugo
- Contact Person Email
- a.aliaga@ntde.es
- Site Name
- Hospital Clinico Universitario De Valladolid
- Principal Investigator Name
- Daniel Antonio de Luis Román
- Principal Investigator Email
- dluisro@saludcastillayleon.es
- Contact Person Name
- Daniel Antonio de Luis Román
- Contact Person Email
- dluisro@saludcastillayleon.es
- Site Name
- Hospital Universitario Clinico San Cecilio
- Principal Investigator Name
- Miguel Quesada Charneco
- Principal Investigator Email
- Miguel.quesada.sspa@juntadeandalucia.es
- Contact Person Name
- Miguel Quesada Charneco
- Contact Person Email
- Miguel.quesada.sspa@juntadeandalucia.es
- Site Name
- Clinica Universidad De Navarra
- Principal Investigator Name
- Javier Escalada
- Principal Investigator Email
- fescalada@unav.es
- Contact Person Name
- Javier Escalada
- Contact Person Email
- fescalada@unav.es
Sponsor
Primary sponsor
- Full Name
- Novo Nordisk A/S
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Denmark
Contract research organisations
- Name
- Icon Clinical Research Limited
- Responsibilities
- Event Adjudication
- Name
- 4G Clinical B.V.
- Responsibilities
- code 3
Third parties
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Event Adjudication","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Celerion Inc.","duties_or_roles":"Special lab-Leptin, soluble leptin receptor","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"eCOA (Study app supplier)","organisation_type":"Pharmaceutical company"}
- {"country":"Netherlands","full_name":"4G Clinical B.V.","duties_or_roles":"code 3","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Oracle America Inc.","duties_or_roles":"code 7","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Abbott GmbH","duties_or_roles":"BG Meter","organisation_type":"Pharmaceutical company"}
- {"country":"Greece","full_name":"Affidea Piraeus Biopathological","duties_or_roles":"Ophthalmological Examinations","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"Finland","full_name":"SYRINX Bioanalytics Oy","duties_or_roles":"Special lab-Anti-Cagrilintide antibodies","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- cagrilintide semaglutide (CagriSema) 1.0 mg/1.0 mg s.c. once weekly
- Active Substance
- CAGRILINTIDE, SEMAGLUTIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Starting Dose
- 1.0 mg/1.0 mg (co-administered), subcutaneous, once weekly (as stated in title)
- Dose Levels
- 1.0 mg/1.0 mg
- Frequency
- Once weekly
- Maximum Dose
- 1.0 mg/1.0 mg
- Investigational Product Name
- Mounjaro 5 mg solution for injection in pre-filled pen (tirzepatide) 5 mg s.c. once weekly
- Active Substance
- TIRZEPATIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- Marketing authorisation EU (EU/1/22/1685/005)
- Starting Dose
- 5 mg, subcutaneous, once weekly
- Dose Levels
- 5 mg
- Frequency
- Once weekly
- Maximum Dose
- 5 mg
- Investigational Product Name
- Mounjaro 2.5 mg solution for injection in pre-filled pen (tirzepatide) 2.5 mg s.c. once weekly
- Active Substance
- TIRZEPATIDE
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS
- Route
- Subcutaneous
- Authorisation Status
- Marketing authorisation EU (EU/1/22/1685/002)
- Starting Dose
- 2.5 mg, subcutaneous, once weekly
- Dose Levels
- 2.5 mg
- Frequency
- Once weekly
- Maximum Dose
- 2.5 mg
- Combination Treatment
- Yes
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