Clinical trial • Phase III • Endocrinology

MARIDEBART CAFRAGLUTIDE for Obesity | Overweight

Phase III trial of MARIDEBART CAFRAGLUTIDE for Obesity | Overweight.

Overview

Trial Therapeutic Area
Endocrinology
Trial Disease
Obesity | Overweight
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
10-02-2025
First CTIS Authorization Date
26-05-2025

Trial design

Randomised, placebo for maridebart cafraglutide (placebo arm). active arms: amg 133 (maridebart cafraglutide) dose 1, amg 133 dose 2, amg 133 dose 3. specific dose amounts and schedules not specified in the part i data.-controlled Phase III trial in Belgium, Czechia, Denmark and others.

Randomised
Yes
Comparator
Placebo for Maridebart Cafraglutide (Placebo arm). Active arms: AMG 133 (maridebart cafraglutide) dose 1, AMG 133 dose 2, AMG 133 dose 3. Specific dose amounts and schedules not specified in the Part I data.
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
2793
Trial Duration For Participant
504

Stratification factors

  • sex assigned at birth (female, male)

Eligibility

Recruits 2793 No vulnerable populations selected (isVulnerablePopulationSelected: false). Adults only (Age ≥ 18). Informed consent must be provided prior to any study-specific activities ("Participant has provided informed consent before initiation of any study-specific ctivities/procedures."). Subject information and informed consent forms (multiple versions) are provided..

Pregnancy Exclusion
Participants of childbearing age with a positive pregnancy test assessed at screening and/or day 1 before randomization
Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false). Adults only (Age ≥ 18). Informed consent must be provided prior to any study-specific activities ("Participant has provided informed consent before initiation of any study-specific ctivities/procedures."). Subject information and informed consent forms (multiple versions) are provided.

Inclusion criteria

  • {"criterion_text":"- Participant has provided informed consent before initiation of any study-specific ctivities/procedures.\n- Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).\n- BMI ≥ 30 kg/m2 at screening, OR BMI ≥ 27 to < 30 kg/m2 at screening, with at least 1 of the following weight-related comorbidities: * hypertension: treated, or with SBP ≥ 130 mmHg or DBP ≥ 80 mmHg * dyslipidemia: treated, or with: LDL ≥ 160 mg/dL (4.1 mmol/L), or triglycerides ≥ 150 mg/dL (1.7 mmol/L), or HDL < 40 mg/dL (1.0 mmol/L) for males or HDL < 50 mg/dL (1.3 mmol/L) for females * obstructive sleep apnea * cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association (NYHA) Class I, II, or III heart failure) * metabolic dysfunction-associated steatotic liver disease\n- History of at least 1 unsuccessful attempt at weight loss by diet and exercise\n- In the opinion of the investigator, well-motivated and willing to follow study procedures for the duration of the study, including, but not limited to: following lifestyle advice, maintaining lifestyle log(s), and completing required study visits and questionnaires"}

Exclusion criteria

  • {"criterion_text":"- Obesity induced by other endocrinologic disorders, monogenetic or syndromic forms of obesity\n- New York Heart Association Class IV heart failure\n- History of unstable major depressive disorder or other severe psychiatric disorder 2 years before screening\n- History of organ transplant or on transplant list\n- History of other conditions that the investigator, may preclude the participant from following the protocol and completing the study\n- Clinically significant gastric-emptying abnormality\n- Use 90 days before randomization of medications, supplements, or alternative remedies for weight loss\n- Use 90 days before randomization of glucose-lowering drugs for the treatment of diabetes\n- Use 90 days before randomization or require use during the trial of medications that may cause significant weight gain including, but not limited to chronic systemic glucocorticoid therapy, tricyclic antidepressants, atypical tetracyclic antidepressants, atypical antipsychotics, lithium, and all formulations of valproic acid\n- Is receiving treatment in another investigational device or drug study, or within 90 days since ending treatment on another investigational device or drug study. This does not apply to other investigational procedures or participation in observational research studies\n- Participation in a study that includes maridebart cafraglutide or AMG 598\n- Self-reported change in body weight > 5kg 90 days before screening\n- Hemoglobin A1c ≥ 6.5% & fasting plasma glucose ≥ 126 mg/dL at screening. If only 1 of the above labs meets the threshold at screening, then the participant should be retested for both & excluded if any repeated test result meets the threshold\n- Estimated glomerular filtration rate < 30 mL/min/1.73 m2 according to 2021 Chronic Kidney Disease Epidemiology Collaboration creatinine-cystatin C equation or receiving dialysis at screening\n- Calcitonin ≥ 50 ng/L at screening\n- Thyroid-stimulating hormone < 0.4 mIU/L or TSH > 6.0 mIU/L with free thyroxine below the lower limit of normal at screening\n- Acute or chronic hepatitis, signs & symptoms of any liver disease other than MASLD, ALT > 3.0 x the upper limit of normal, or total bilirubin > 1.2 x ULN\n- Systolic blood pressure ≥ 180 mmHg and/or DBP ≥ 120 mmHg at screening\n- Patient Health Questionnaire-9 score of ≥ 15 on day 1 before randomization\n- Suicidal ideation of category 4 or 5 on the Columbia-Suicide Severity Rating Scale Baseline version at screening, or on the C-SSRS Since Last Visit version on day 1 before randomization\n- History of suicide attempt evaluated through C-SSRS Baseline version at screening or any suicidal behavior on the C-SSRS Since Last Visit version on day 1 before randomization\n- Participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment & the 16 weeks after last dose of investigational product\n- Previous or planned surgical, endoscopic, or device-based treatment for obesity\n- Participants who are breastfeeding or plan to breastfeed while on study through 16 weeks after last dose of investigational product\n- Participants planning to become pregnant while on study and 16 weeks after the last dose of investigational product\n- Participants of childbearing age with a positive pregnancy test assessed at screening and/or day 1 before randomization\n- Any disorder, unwillingness, or inability, not covered by the other exclusion criteria, that in the investigator’s opinion, might jeopardize the participant’s safety or compliance with the protocol\n- Major surgery planned during the study\n- Investigative site personnel directly affiliated with the study and/or their immediate family\n- Participant has known sensitivity to any of the products or components to be administered during dosing\n- History of malignancy 5 years before screening\n- Type 1 or 2 diabetes mellitus or any other types of diabetes mellitus\n- History of chronic pancreatitis\n- History of acute pancreatitis 180 days before screening\n- Family or personal history of MTC or multiple endocrine neoplasia syndrome type 2\n- History of the following 60 days before screening: myocardial infarction, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke, or hospitalization for unstable angina, heart failure, or transient ischemic attack"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Percent change from baseline in body weight at week 72","definition_or_measurement_approach":"Percent change from baseline in body weight measured at week 72 (primary efficacy comparison: maridebart cafraglutide versus placebo)"}

Secondary endpoints

  • {"endpoint_text":"- Change from baseline in waist circumference (cm) at week 72","definition_or_measurement_approach":"Absolute change from baseline in waist circumference measured in cm at week 72"}
  • {"endpoint_text":"- Achieving ≥5% reduction in body weight from baseline at week 72","definition_or_measurement_approach":"Proportion of participants achieving ≥5% reduction in body weight from baseline at week 72"}
  • {"endpoint_text":"- Achieving ≥10% reduction in body weight from baseline at week 72","definition_or_measurement_approach":"Proportion of participants achieving ≥10% reduction in body weight from baseline at week 72"}
  • {"endpoint_text":"- Achieving ≥15% reduction in body weight from baseline at week 72","definition_or_measurement_approach":"Proportion of participants achieving ≥15% reduction in body weight from baseline at week 72"}
  • {"endpoint_text":"- Achieving ≥20% reduction in body weight from baseline at week 72","definition_or_measurement_approach":"Proportion of participants achieving ≥20% reduction in body weight from baseline at week 72"}
  • {"endpoint_text":"- Change from baseline in SBP (mmHg) at week 72","definition_or_measurement_approach":"Change from baseline in systolic blood pressure measured in mmHg at week 72"}
  • {"endpoint_text":"- Percent change from baseline in fasting triglycerides at week 72","definition_or_measurement_approach":"Percent change from baseline in fasting triglyceride concentration at week 72"}
  • {"endpoint_text":"- Change from baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at week 72","definition_or_measurement_approach":"Change from baseline in IWQOL-Lite-CT Physical Function Composite Score at week 72 (patient-reported outcome)"}
  • {"endpoint_text":"- Change from baseline in fasting plasma glucose at week 72","definition_or_measurement_approach":"Change from baseline in fasting plasma glucose measured at week 72"}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
2793
Recruitment Window Months
22
Consent Approach
Informed consent must be provided prior to any study-specific activities ("Participant has provided informed consent before initiation of any study-specific ctivities/procedures."). Subject information and informed consent forms (L1/L2 SIS and ICF) are available in multiple language versions (examples in the documents list include English, German, Spanish, Polish, Italian, Finnish, Danish, Czech, Dutch, French). Specialized ICFs are available (e.g., pregnancy ICF, home dosing ICF, genetic research, DXA substudy). No assent for minors is described (study enrols adults ≥18).

Methods

  • Physician referral letters (doctor-to-patient) — channel: referral letters for physicians; country-specific versions available (e.g., Germany).
  • Site advertisements and site website/intranet advertisements — channel: advertisements on site premises and site websites/intranets (documents: 'Advertisement on sites', 'Advertisement on sites website or intranet').
  • Patient brochures and digital patient brochure — channel: printed and digital brochures for prospective participants (documents: 'Patient Brochure', 'Digital Patient Brochure').
  • Pre-enrollment cards and study pre-consent information — channel: pre-enrollment materials provided at sites to potential participants (documents: 'Patient Pre-Enrollment Card', 'Study Pre-Consent Information').
  • Sanos Clinics recruitment materials (country-specific) — channel: clinic network recruitment (document: 'K2_Recruitment material Sanos Clinics' associated with Denmark).
  • Invitation letters to potential participants and doctor-to-patient letters — channel: direct mail/email to potential participants via sites.
  • Site-level recruitment texts/templates (country-specific) — channel: standardized recruitment texts/templates for use by individual sites (e.g., Germany 'Sigal Recruitment Texts for site 26033').

Geography

Total Number Of Sites
98
Total Number Of Participants
1060

Belgium

Earliest CTIS Part Ii Submission Date
2025-05-05
Latest Decision Or Authorization Date
2025-05-26
Processing Time Days
21
Number Of Sites
7
Number Of Participants
59

Sites

Site Name
Emmaues
Department Name
Endocrinologie
Principal Investigator Name
Anne-Marie Vandenbroucke
Principal Investigator Email
anne-marie.vandenbroucke@emmaus.be
Contact Person Name
Anne-Marie Vandenbroucke
Site Name
Centre hospitalier universitaire de Liege
Department Name
Service de diabétologie, nutrition, maladies métaboliques
Principal Investigator Name
Nathalie Esser
Principal Investigator Email
nathalie.esser@chuliege.be
Contact Person Name
Nathalie Esser
Contact Person Email
nathalie.esser@chuliege.be
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Endocrinology, Diabetology and Metabolic
Principal Investigator Name
Eveline Dirinck
Principal Investigator Email
eveline.dirinck@uantwerpen.be
Contact Person Name
Eveline Dirinck
Contact Person Email
eveline.dirinck@uantwerpen.be
Site Name
UZ Leuven
Department Name
Endocrinology
Principal Investigator Name
Roman Vangoitsenhoven
Principal Investigator Email
roman.Vangoitshoven@uzleuven.be
Contact Person Name
Roman Vangoitsenhoven
Site Name
CHU Helora
Department Name
Endocrinologie – Diabetologie
Principal Investigator Name
Ides Michel Colin
Principal Investigator Email
Ides.Michel.COLIN@helora.be
Contact Person Name
Ides Michel Colin
Contact Person Email
Ides.Michel.COLIN@helora.be
Site Name
Algemeen Ziekenhuis Groeninge
Department Name
Endocrinologie - Diabetologie
Principal Investigator Name
Gerd Vanhaverbeke
Principal Investigator Email
gerd.vanhaverbeke@azgroeninge.be
Contact Person Name
Gerd Vanhaverbeke
Site Name
Universitair Ziekenhuis Gent
Department Name
Endocrinologie en stofwisselingsziekten
Principal Investigator Name
Imke Matthys
Principal Investigator Email
Imke.matthys@uzgent.be
Contact Person Name
Imke Matthys
Contact Person Email
Imke.matthys@uzgent.be

Czechia

Earliest CTIS Part Ii Submission Date
2025-05-06
Latest Decision Or Authorization Date
2025-05-28
Processing Time Days
22
Number Of Sites
11
Number Of Participants
94

Sites

Site Name
Institute For Clinical And Experimental Medicine
Department Name
IKEM, Centrum diabetologie, Vídeňská 1958/9, 140 21 Praha 4
Principal Investigator Name
Martin Haluzík
Principal Investigator Email
halm@ikem.cz
Contact Person Name
Martin Haluzík
Contact Person Email
halm@ikem.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Všeobecná Interní klinika FN Brno, Jihlavská 20, 625 00 Brno
Principal Investigator Name
Ondřej Ludka
Principal Investigator Email
Ludka.Ondrej@fnbrno.cz
Contact Person Name
Ondřej Ludka
Contact Person Email
Ludka.Ondrej@fnbrno.cz
Site Name
Endohope Havirov s.r.o.
Department Name
Endohope Havířov, Podlesí, Dlouhá třída 1134/83, Havířov, 736 01
Principal Investigator Name
Evžen Machytka
Principal Investigator Email
machytka@endohope.cz
Contact Person Name
Evžen Machytka
Contact Person Email
machytka@endohope.cz
Site Name
Medicus Services s.r.o.
Department Name
Medicus services s.r.o., Kardiologická poradna, Nadrazni 1317/5, Brandýs nad Labem, 250 01
Principal Investigator Name
Jiří Krupička
Principal Investigator Email
jikru@volny.cz
Contact Person Name
Jiří Krupička
Contact Person Email
jikru@volny.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Fakultní nemocnice Královské Vinohrady, Diabetologické centrum, Šrobárova 1150/50, Praha 10, 100 34
Principal Investigator Name
Ludmila Brunerová
Principal Investigator Email
ludmila.brunerova@fnkv.cz
Contact Person Name
Ludmila Brunerová
Contact Person Email
ludmila.brunerova@fnkv.cz
Site Name
Endokrinologie Cerny Most s.r.o.
Department Name
Endokrinologie Černý Most, s.r.o., Generála Janouška 902/17, 198 00 Praha 9
Principal Investigator Name
Lukáš Zlatohlávek
Principal Investigator Email
lukas.zlatohlavek@gmail.com
Contact Person Name
Lukáš Zlatohlávek
Contact Person Email
lukas.zlatohlavek@gmail.com
Site Name
OB klinika a.s.
Department Name
Fakultní nemocnice Královské Vinohrady, Diabetologické centrum, (OB klinika a.s. entry: Centrum pro léčbu obezity a metabolických poruch)
Principal Investigator Name
Petra Šrámková
Principal Investigator Email
petra.sramkova@obklinika.cz
Contact Person Name
Petra Šrámková
Contact Person Email
petra.sramkova@obklinika.cz
Site Name
Endohope klinika s.r.o.
Department Name
Endohope Praha Smíchov, Kartouzská 204/06, Praha 5 - Smíchov, 150 00
Principal Investigator Name
Jana Selucká
Principal Investigator Email
studie.selucka@seznam.cz
Contact Person Name
Jana Selucká
Contact Person Email
studie.selucka@seznam.cz
Site Name
CCR Ostrava s.r.o.
Department Name
CCR Ostrava s.r.o., 28. října 3348/65, 702 00
Principal Investigator Name
Sylva Brtníková
Principal Investigator Email
sylva.brtnikova@ccrostrava.com
Contact Person Name
Sylva Brtníková
Contact Person Email
sylva.brtnikova@ccrostrava.com
Site Name
Vseobecna Fakultni Nemocnice V Praze
Department Name
III. inter. klin. 1.LF UK a VFN v Praze,Diabet. a Obez. cen. VFN,Fakul. pol. VFN,Karlovo nam. 554/32
Principal Investigator Name
Martin Prázný
Principal Investigator Email
martin.prazny@outlook.com
Contact Person Name
Martin Prázný
Contact Person Email
martin.prazny@outlook.com
Site Name
PreventaMed s.r.o.
Department Name
PreventaMed, s.r.o., Vila zdraví, Domovina 2, 779 00 Olomouc
Principal Investigator Name
Jiří Pumprla
Principal Investigator Email
research@vilazdravi.cz
Contact Person Name
Jiří Pumprla
Contact Person Email
research@vilazdravi.cz

Denmark

Earliest CTIS Part Ii Submission Date
2025-05-21
Latest Decision Or Authorization Date
2025-05-27
Processing Time Days
6
Number Of Sites
7
Number Of Participants
77

Sites

Site Name
Region Midtjylland
Department Name
Endocrinology & metabolism
Principal Investigator Name
Soren Nielsen
Principal Investigator Email
soerniel@rm.dk
Contact Person Name
Soren Nielsen
Contact Person Email
soerniel@rm.dk
Site Name
Gentofte Hospital
Department Name
Endocrinology & metabolism
Principal Investigator Name
Asger Bach Lund
Principal Investigator Email
Asger.Lund.01@regionh.dk
Contact Person Name
Asger Bach Lund
Contact Person Email
Asger.Lund.01@regionh.dk
Site Name
Sanos A/S (Herlev)
Department Name
Cardiology
Principal Investigator Name
Bernt Husoy
Principal Investigator Email
bhu@sanosclinic.com
Contact Person Name
Bernt Husoy
Contact Person Email
bhu@sanosclinic.com
Site Name
Region Hovedstaden
Department Name
Endocrinology & metabolism
Principal Investigator Name
Carsten Dirksen
Principal Investigator Email
carsten.dirksen@regionh.dk
Contact Person Name
Carsten Dirksen
Contact Person Email
carsten.dirksen@regionh.dk
Site Name
Sanos A/S (Borgergade)
Department Name
Cardiology
Principal Investigator Name
Cecilie Rovsing
Principal Investigator Email
cec@sanosclinic.com
Contact Person Name
Cecilie Rovsing
Contact Person Email
cec@sanosclinic.com
Site Name
Region Midtjylland (Herning)
Department Name
Endocrinology & metabolism
Principal Investigator Name
Morten Bottcher
Principal Investigator Email
morboett@rm.dk
Contact Person Name
Morten Bottcher
Contact Person Email
morboett@rm.dk
Site Name
Steno Diabetes Center Copenhagen
Department Name
Cardiology
Principal Investigator Name
Trine Nielsen
Principal Investigator Email
trine.nielsen.01@regionh.dk
Contact Person Name
Trine Nielsen
Contact Person Email
trine.nielsen.01@regionh.dk

Finland

Earliest CTIS Part Ii Submission Date
2025-05-07
Latest Decision Or Authorization Date
2025-06-02
Processing Time Days
26
Number Of Sites
3
Number Of Participants
50

Sites

Site Name
Health Step Finland Oy (Medistudia, Kuopio)
Department Name
Clinical trials
Principal Investigator Name
Timo Lakka
Principal Investigator Email
timo.lakka@uef.fi
Contact Person Name
Timo Lakka
Contact Person Email
timo.lakka@uef.fi
Site Name
HUS-Yhtymae (Helsinki)
Department Name
Obesity Research Unit
Principal Investigator Name
Kirsi Pietilainen
Principal Investigator Email
kirsi.pietilainen@helsinki.fi
Contact Person Name
Kirsi Pietilainen
Contact Person Email
kirsi.pietilainen@helsinki.fi
Site Name
Pohjois-Pohjanmaan hyvinvointialue (Oulu)
Department Name
Research unit
Principal Investigator Name
Janne Hukkanen
Principal Investigator Email
janne.hukkanen@oulu.fi
Contact Person Name
Janne Hukkanen
Contact Person Email
janne.hukkanen@oulu.fi

Germany

Earliest CTIS Part Ii Submission Date
2025-05-13
Latest Decision Or Authorization Date
2025-05-27
Processing Time Days
14
Number Of Sites
33
Number Of Participants
473

Sites

Site Name
Velocity Clinical Research GmBH
Department Name
-
Principal Investigator Name
Isabelle Schenkenberger
Principal Investigator Email
ISchenkenberger@velocityclinical.com
Contact Person Name
Isabelle Schenkenberger
Site Name
Zentrum für Klinische Studien Bad Homburg
Department Name
-
Principal Investigator Name
Seyed Yasser Saiedi Hosseini
Principal Investigator Email
saiedi@kpwj.de
Contact Person Name
Seyed Yasser Saiedi Hosseini
Contact Person Email
saiedi@kpwj.de
Site Name
Diabeteszentrum Hamburg West
Department Name
Innere Medizin, Diabetologie
Principal Investigator Name
Dominik Dahl
Principal Investigator Email
info@dzhw.de
Contact Person Name
Dominik Dahl
Contact Person Email
info@dzhw.de
Site Name
Universitaetsklinikum Aachen AöR
Department Name
-
Principal Investigator Name
Julia Brandts
Principal Investigator Email
jbrandts@ukaachen.de
Contact Person Name
Julia Brandts
Contact Person Email
jbrandts@ukaachen.de
Site Name
Zentrum fuer klinische Studien Suedbrandenburg GmbH
Department Name
-
Principal Investigator Name
Andreas Hagenow
Principal Investigator Email
a.hagenow@zks-sbb.com
Contact Person Name
Andreas Hagenow
Contact Person Email
a.hagenow@zks-sbb.com
Site Name
Diabetespraxis Dr. Braun
Department Name
Innere Medizin, Diabetologie
Principal Investigator Name
Hermann Braun
Principal Investigator Email
braun@diabetespraxis-braun.de
Contact Person Name
Hermann Braun
Contact Person Email
braun@diabetespraxis-braun.de
Site Name
ClinPhenomics CVC GmbH
Department Name
Innere Medizin und Kardiologie
Principal Investigator Name
Martin Duersch
Principal Investigator Email
m.duersch@clph.de
Contact Person Name
Martin Duersch
Contact Person Email
m.duersch@clph.de
Site Name
Praxis am Markt Dr. Becker
Department Name
-
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
InnoDiab Forschung GmbH
Department Name
-
Principal Investigator Name
Thomas Schürholz
Principal Investigator Email
thomas.schuerholz@innodiab.de
Contact Person Name
Thomas Schürholz
Contact Person Email
thomas.schuerholz@innodiab.de
Site Name
Universitaet Leipzig
Department Name
Klinik u. Poliklinik für Endokrinologie, Nephrologie, Rheumatologie
Principal Investigator Name
Matthias Blueher
Principal Investigator Email
matthias.blueher@medizin.uni-leipzig.de
Contact Person Name
Matthias Blueher
Site Name
MVZ DiaMedicum Bad Mergentheim GmbH
Department Name
-
Principal Investigator Name
Simon Vidal
Principal Investigator Email
vidal@diabetespraxis.de
Contact Person Name
Simon Vidal
Contact Person Email
vidal@diabetespraxis.de
Site Name
Zentrum für klinische Studien Alexander Segner
Department Name
-
Principal Investigator Name
Alexander Segner
Principal Investigator Email
alexander.segner@zks-igb.de
Contact Person Name
Alexander Segner
Contact Person Email
alexander.segner@zks-igb.de
Site Name
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum
Department Name
Klinik für Diabetologie und Endokrinologie, Diabeteszentrum
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
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Endokrinologie, Stoffwechsel- und Ernaehrungsmedizin
Principal Investigator Name
Lukas Maurer
Principal Investigator Email
lukas.maurer@charite.de
Contact Person Name
Lukas Maurer
Contact Person Email
lukas.maurer@charite.de
Site Name
Praxis für Prävention und Therapie Prof. Dr. med. Stephan Jacob
Department Name
-
Principal Investigator Name
Stephan Jacob
Principal Investigator Email
prof.dr.jacob@web.de
Contact Person Name
Stephan Jacob
Contact Person Email
prof.dr.jacob@web.de
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden
Department Name
Medizinische Klinik und Poliklinik III - Studienzentrum für Stoffwechselerkrankungen
Principal Investigator Name
Nikolaos Perakakis
Principal Investigator Email
nikolaos.perakakis@uniklinikum-dresden.de
Contact Person Name
Nikolaos Perakakis
Site Name
Marienhaus Klinikum Mainz GmbH
Department Name
Klinik für Innere Medizin 1, Kardiologie
Principal Investigator Name
Sabine Genth-Zotz
Principal Investigator Email
Sabine.Genth-Zotz@marienhaus.de
Contact Person Name
Sabine Genth-Zotz
Site Name
Medical Center - University Of Freiburg
Department Name
Klinik fuer Kardiologie und Angiologie II
Principal Investigator Name
Stefan Leggewie
Principal Investigator Email
stefan.leggewie@uniklinik-freiburg.de
Contact Person Name
Stefan Leggewie
Site Name
Zentrum für klinische Studien Allgäu Oberschwaben. Praxis Sauter & Sauter & Dr. Vorbach
Department Name
-
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
Institut fuer Diabetesforschung Muenster GmbH
Department Name
-
Principal Investigator Name
Ludger Rose
Principal Investigator Email
l.rose@diabetes-muenster.de
Contact Person Name
Ludger Rose
Contact Person Email
l.rose@diabetes-muenster.de
Site Name
Zentrum für klinische Studien
Department Name
-
Principal Investigator Name
Alexander Segner
Principal Investigator Email
alexander.segner@zks-igb.de
Contact Person Name
Alexander Segner
Contact Person Email
alexander.segner@zks-igb.de
Site Name
Praxis am Bahnhof Spandau
Department Name
-
Principal Investigator Name
Uta Dorothea Stephan
Principal Investigator Email
utdost@web.de
Contact Person Name
Uta Dorothea Stephan
Contact Person Email
utdost@web.de
Site Name
R.E.D. Institut fuer medizinische Studien und Fortbildung GmbH
Department Name
-
Principal Investigator Name
Thomas Schaum
Principal Investigator Email
hecht@red-institut.de
Contact Person Name
Thomas Schaum
Contact Person Email
hecht@red-institut.de
Site Name
Praxis fuer Prävention und Therapie Prof. Dr. med. Stephan Jacob (Villingen-Schwenningen)
Department Name
-
Principal Investigator Name
Stephan Jacob
Principal Investigator Email
prof.dr.jacob@web.de
Contact Person Name
Stephan Jacob
Contact Person Email
prof.dr.jacob@web.de
Site Name
Diabetologische Schwerpunktpraxis Hohenmoelsen-Weissenfels
Department Name
-
Principal Investigator Name
Karsten Milek
Principal Investigator Email
office@doc-milek.com
Contact Person Name
Karsten Milek
Contact Person Email
office@doc-milek.com
Site Name
Ambenet GmbH Das Ambulante Behandlungsnetz
Department Name
-
Principal Investigator Name
Hans-Detlev Stahl
Principal Investigator Email
studien@ambenet.de
Contact Person Name
Hans-Detlev Stahl
Contact Person Email
studien@ambenet.de
Site Name
MVZ DiaMedicum Bad Mergentheim GmbH (duplicate listing)
Department Name
-
Principal Investigator Name
Simon Vidal
Principal Investigator Email
vidal@diabetespraxis.de
Contact Person Name
Simon Vidal
Contact Person Email
vidal@diabetespraxis.de

Italy

Earliest CTIS Part Ii Submission Date
2025-05-14
Latest Decision Or Authorization Date
2025-05-28
Processing Time Days
14
Number Of Sites
6
Number Of Participants
20

Sites

Site Name
ASST Fatebenefratelli Sacco
Department Name
Malattie Endocrine e Diabetologia
Principal Investigator Name
Paolo Fiorina
Principal Investigator Email
paolo.fiorina@asst-fbf-sacco.it
Contact Person Name
Paolo Fiorina
Site Name
Azienda Ospedaliero Universitaria Careggi
Department Name
Dipartimento Medico Geriatrico
Principal Investigator Name
Edoardo Mannucci
Principal Investigator Email
edoardo.mannucci@unifi.it
Contact Person Name
Edoardo Mannucci
Contact Person Email
edoardo.mannucci@unifi.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Dipartimento Medico chirurgico delle malattie digestive epatiche ed endocrino metaboliche
Principal Investigator Name
Uberto Pagotto
Principal Investigator Email
uberto.pagotto@unibo.it
Contact Person Name
Uberto Pagotto
Contact Person Email
uberto.pagotto@unibo.it
Site Name
Centro Cardiologico Monzino S.p.A.
Department Name
Unita di Diabetologia, Endocrinologia e Malattie Metaboliche
Principal Investigator Name
Stefano Genovese
Principal Investigator Email
Stefano.Genovese@cardiologicomonzino.it
Contact Person Name
Stefano Genovese
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Stabilimento Cisanello Unità Operativa di Endocrinologia 1
Principal Investigator Name
Ferruccio Santini
Principal Investigator Email
ferruccio.santini@unipi.it
Contact Person Name
Ferruccio Santini
Contact Person Email
ferruccio.santini@unipi.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
Unità Operativa Complessa Medicina Interna Centro medico dell'obesità
Principal Investigator Name
Paolo Sbraccia
Principal Investigator Email
sbraccia@med.uniroma2.it
Contact Person Name
Paolo Sbraccia
Contact Person Email
sbraccia@med.uniroma2.it

Poland

Earliest CTIS Part Ii Submission Date
2025-05-13
Latest Decision Or Authorization Date
2025-06-01
Processing Time Days
19
Number Of Sites
12
Number Of Participants
179

Sites

Site Name
Futuremeds Sp. z o.o. (Warsaw)
Principal Investigator Name
Olga Jeziorska
Principal Investigator Email
olga.jeziorska@futuremeds.com
Contact Person Name
Olga Jeziorska
Contact Person Email
olga.jeziorska@futuremeds.com
Site Name
Ekamed Sp. z o.o. (Lublin)
Principal Investigator Name
Ewa Skokowska
Principal Investigator Email
ewa.skokowska@ekamed.pl
Contact Person Name
Ewa Skokowska
Contact Person Email
ewa.skokowska@ekamed.pl
Site Name
Futuremeds Sp. z o.o. (Gdynia)
Principal Investigator Name
Katarzyna Szudejko
Principal Investigator Email
DL_Gdynia@futuremeds.com
Contact Person Name
Katarzyna Szudejko
Contact Person Email
DL_Gdynia@futuremeds.com
Site Name
Clinical Research Center Sp. z o.o. Medic-R sp.k.
Principal Investigator Name
Wojciech Telec
Principal Investigator Email
agnieszka.kmieciak@cr-center.pl
Contact Person Name
Wojciech Telec
Site Name
Clinical Best Solutions Sp. z o.o. S.K.
Principal Investigator Name
Magdalena Szuflinska-Sidorowicz
Principal Investigator Email
magda.szuflinska@gmail.com
Contact Person Name
Magdalena Szuflinska-Sidorowicz
Contact Person Email
magda.szuflinska@gmail.com
Site Name
Centrum Zdrowia Metabolicznego Pawel Bogdanski
Principal Investigator Name
Pawel Bogdanski
Principal Investigator Email
pawelbogdanski73@gmail.com
Contact Person Name
Pawel Bogdanski
Contact Person Email
pawelbogdanski73@gmail.com
Site Name
Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name
Clinic of Internal, Autoimmune, and Metabolic Diseases
Principal Investigator Name
Michal Holecki
Principal Investigator Email
holomed@gmail.com
Contact Person Name
Michal Holecki
Contact Person Email
holomed@gmail.com
Site Name
Kresmed Sp. z o. o.
Principal Investigator Name
Barbara Stogowska-Nikiciuk
Principal Investigator Email
basia_stogowska@poczta.onet.pl
Contact Person Name
Barbara Stogowska-Nikiciuk
Contact Person Email
basia_stogowska@poczta.onet.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
ETG Lublin Sp. z o.o.
Principal Investigator Name
Marek Styczkiewicz
Principal Investigator Email
m.styczkiewicz@etg-network.com
Contact Person Name
Marek Styczkiewicz
Contact Person Email
m.styczkiewicz@etg-network.com
Site Name
GABINET LECZENIA OTYŁOSCI I CHOROB DIETOZALEZNYCH - dr hab.n.med. Lucyna Ostrowska
Principal Investigator Name
Lucyna Ostrowska
Principal Investigator Email
lucyna.ostrowska.db@gmail.com
Contact Person Name
Lucyna Ostrowska
Contact Person Email
lucyna.ostrowska.db@gmail.com
Site Name
Salvia Lekston I Madej Sp. j.
Principal Investigator Name
Marcin Basiak
Principal Investigator Email
marcinbasiak@tlen.pl
Contact Person Name
Marcin Basiak
Contact Person Email
marcinbasiak@tlen.pl

Spain

Earliest CTIS Part Ii Submission Date
2025-05-16
Latest Decision Or Authorization Date
2025-06-02
Processing Time Days
17
Number Of Sites
13
Number Of Participants
108

Sites

Site Name
Centro Periferico De Especialidades Bola Azul
Department Name
Servicio Medicina Interna
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
Clinica Universidad De Navarra (Madrid)
Department Name
Servicio de Endocrinologia
Principal Investigator Name
Javier Escalada San Martin
Principal Investigator Email
fescalada@unav.es
Contact Person Name
Javier Escalada San Martin
Contact Person Email
fescalada@unav.es
Site Name
Clinica Universidad De Navarra (Pamplona)
Department Name
Servicio de Endocrinologia
Principal Investigator Name
Javier Escalada San Martin
Principal Investigator Email
fescalada@unav.es
Contact Person Name
Javier Escalada San Martin
Contact Person Email
fescalada@unav.es
Site Name
Hospital Quironsalud Infanta Luisa
Department Name
Servicio de Endocrinologia
Principal Investigator Name
Margarita Rivas Fernandez
Principal Investigator Email
margaritarivasfernandez@yahoo.es
Contact Person Name
Margarita Rivas Fernandez
Site Name
Hospital Virgen Del Camino
Department Name
Servicio Medicina Interna
Principal Investigator Name
Manuel Beltran Robles
Principal Investigator Email
mbrobles76@hotmail.com
Contact Person Name
Manuel Beltran Robles
Contact Person Email
mbrobles76@hotmail.com
Site Name
Hospital Nisa Sevilla Aljarafe
Department Name
Unidad Salud CardioMetabólica Diabetes y Obesidad
Principal Investigator Name
Cristobal Jesus Morales Portillo
Principal Investigator Email
cr.morales@hotmail.com
Contact Person Name
Cristobal Jesus Morales Portillo
Contact Person Email
cr.morales@hotmail.com
Site Name
Instituto Medico Quirurgico San Rafael S.A.
Department Name
Servicio de Endocrinologia
Principal Investigator Name
Alfonso Soto Gonzalez
Principal Investigator Email
asotog30@outlook.es
Contact Person Name
Alfonso Soto Gonzalez
Contact Person Email
asotog30@outlook.es
Site Name
Hospital Ruber Juan Bravo
Department Name
Servicio de Endocrinologia
Principal Investigator Name
Esteban Jodar Gimeno
Principal Investigator Email
secretariadireccion.rjb@quironsalud.es
Contact Person Name
Esteban Jodar Gimeno
Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
Servicio de Endocrinologia
Principal Investigator Name
Juan Diego Salazar Leon
Principal Investigator Email
mdjuansalazar@gmail.com
Contact Person Name
Juan Diego Salazar Leon
Contact Person Email
mdjuansalazar@gmail.com
Site Name
Clinica Juaneda S.A.
Department Name
Unidad de Obesidad
Principal Investigator Name
Santiago Tofe Povedano
Principal Investigator Email
santiago.tofe@ssib.es
Contact Person Name
Santiago Tofe Povedano
Contact Person Email
santiago.tofe@ssib.es
Site Name
Nuevas Tecnologias En Diabetes Y En Endocrinologia S.L. Profesional
Department Name
Servicio Endocrinologia
Principal Investigator Name
Alberto Aliaga Verdugo
Principal Investigator Email
info@ntde.es
Contact Person Name
Alberto Aliaga Verdugo
Contact Person Email
info@ntde.es
Site Name
Clinica Universidad De Navarra (other site)
Department Name
Servicio de Endocrinologia
Principal Investigator Name
Javier Escalada San Martin
Principal Investigator Email
fescalada@unav.es
Contact Person Name
Javier Escalada San Martin
Contact Person Email
fescalada@unav.es

Sponsor

Primary sponsor

Full Name
Amgen Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Bioclinica Inc.
Responsibilities
Imaging (DXA)
Name
IQVIA Limited
Responsibilities
Recruitment and Retention, eCOA, DCT, eConsent, ABPM, Monitoring, Optional Dietician resource
Name
Suvoda LLC
Name
Altasciences Compagnie Inc.
Name
Medidata Solutions Inc.
Name
Labcorp Central Laboratory Services SARL
Name
Bioagilytix Labs LLC

Third parties

  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Imaging (DXA)","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Recruitment and Retention, eCOA, DCT, eConsent, ABPM, Monitoring, Optional Dietician resource","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
AMG 133
Active Substance
MARIDEBART CAFRAGLUTIDE
Modality
Monoclonal antibody
Routes Of Administration
SUBCUTANEOUS USE
Route
Subcutaneous
Investigational Product Name
Placebo for Maridebart Cafraglutide
Modality
Other
Combination Treatment
Yes

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