Clinical trial • Phase II • Endocrinology

MARIDEBART CAFRAGLUTIDE for Type 2 diabetes mellitus

Phase II trial of MARIDEBART CAFRAGLUTIDE for Type 2 diabetes mellitus. Randomised, placebo for amg 133 (placebo)-controlled. 180 participants.

Overview

Trial Therapeutic Area
Endocrinology
Trial Disease
Type 2 diabetes mellitus
Trial Stage
Phase II
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
18-07-2024
First CTIS Authorization Date
08-11-2024

Trial design

Randomised, placebo for amg 133 (placebo)-controlled Phase II trial in Austria, Italy, Spain and others.

Randomised
Yes
Comparator
Placebo for AMG 133 (placebo)
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
180
Trial Duration For Participant
168

Eligibility

Recruits 180 Vulnerable population not selected. Subjects are adults (Age ≥ 18 years, or legal adult age per country) and must provide informed consent prior to any study-specific activities/procedures..

Vulnerable Population
Vulnerable population not selected. Subjects are adults (Age ≥ 18 years, or legal adult age per country) and must provide informed consent prior to any study-specific activities/procedures.

Inclusion criteria

  • {"criterion_text":"- Subject has provided informed consent before initiation of any study-specific activities/procedures."}
  • {"criterion_text":"- Age ≥ 18 years at screening (or ≥ legal age within the country if it is older than 18 years)."}
  • {"criterion_text":"- BMI of ≥ 23 to ≤ 50 kg/m2 at screening"}
  • {"criterion_text":"- Diagnosis of T2DM at least 180 days before screening based on the World Health Organization (WHO) classification"}
  • {"criterion_text":"- HbA1c at screening of ≥ 7.0% (53.0 mmol/mol) and ≤ 10.5% (91.3 mmol/mol)."}
  • {"criterion_text":"- Treatment of T2DM with a stable dose of metformin (either immediate release or extended release, ≥ 1000 mg/day and not more than the locally approved dose) with or without an SGLT2-inhibitor for at least 90 days before screening."}
  • {"criterion_text":"- Subject is able and willing to comply with the requirements of the study protocol including SMBG and completion of subject diary"}

Exclusion criteria

  • {"criterion_text":"- Type 1 diabetes mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes, except T2DM."}
  • {"criterion_text":"- Fasting glucose > 270 mg/dL (15.0 mmol/L) at screening."}
  • {"criterion_text":"- History of proliferative diabetic retinopathy, diabetic macular edema, or non-proliferative diabetic retinopathy that requires acute treatment (based on a fundoscopic examination performed by an ophthalmologist or another suitably qualified healthcare provider [eg, optometrist] within 90 days before screening or in the period between screening and randomization)."}
  • {"criterion_text":"- Change in body weight > 5 kg within 90 days before screening, per subject report or medical records."}
  • {"criterion_text":"- One or more episode of severe hypoglycemia within 180 days before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, or history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Change from baseline to week 24 in hemoglobin A1c (HbA1c)","definition_or_measurement_approach":"Change from baseline to week 24 in hemoglobin A1c (HbA1c); measured as the difference in HbA1c between baseline and Week 24."}

Secondary endpoints

  • {"endpoint_text":"- Percent change from baseline to week 24 in body weight","definition_or_measurement_approach":"Percent change in body weight from baseline to Week 24."}
  • {"endpoint_text":"- Achieving HbA1c < 7.0% at week 24 Achieving HbA1c ≤ 6.5% at week 24","definition_or_measurement_approach":"Proportion of subjects achieving specified HbA1c thresholds (<7.0% and ≤6.5%) at Week 24."}
  • {"endpoint_text":"- Achieving ≥ 5% reduction in body weight from baseline at week 24 Achieving ≥ 10% reduction in body weight from baseline at week 24","definition_or_measurement_approach":"Proportion of subjects achieving ≥5% and ≥10% body weight reduction from baseline at Week 24."}
  • {"endpoint_text":"- Change from baseline to week 24 in fasting glucose","definition_or_measurement_approach":"Change in fasting plasma glucose from baseline to Week 24."}
  • {"endpoint_text":"- Percent changes from baseline to week 24 in total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), non-high density lipoprotein cholesterol (non-HDL-C), very-low-density lipoprotein cholesterol (VLDL-C), triglycerides, and free fatty acids (FFA)","definition_or_measurement_approach":"Percent change from baseline to Week 24 for listed lipid parameters and free fatty acids."}
  • {"endpoint_text":"- Changes from baseline to week 24 in systolic blood pressure (SBP) and diastolic blood pressure (DBP)","definition_or_measurement_approach":"Change in SBP and DBP from baseline to Week 24."}
  • {"endpoint_text":"- Plasma maridebart cafraglutide concentrations including observed predose plasma concentration (Cpredose) at week 20 and, if available, maximum observed plasma concentration (Cmax) as defined by week 20 day 5 to 14 postdose sample","definition_or_measurement_approach":"PK assessment: predose plasma concentration (Cpredose) at Week 20 and, if available, Cmax defined from postdose samples from Day 5 to Day 14 of Week 20."}
  • {"endpoint_text":"- Incidence of treatment-emergent adverse events and serious adverse events","definition_or_measurement_approach":"Incidence rates of TEAEs and SAEs during the treatment period."}
  • {"endpoint_text":"- Incidence of anti-maridebart cafraglutide antibody formation including neutralizing antibodies against native glucagon-like peptide 1 (GLP-1)","definition_or_measurement_approach":"Incidence of anti-drug antibodies, including neutralizing antibodies against native GLP-1."}
  • {"endpoint_text":"- Change from baseline to week 24 in high-sensitivity C-reactive protein (hs-CRP)","definition_or_measurement_approach":"Change in hs-CRP from baseline to Week 24."}

Recruitment

Planned Sample Size
180
Recruitment Window Months
23
Consent Approach
Written informed consent must be provided by each subject before any study-specific procedures. Subjects are adults (Age ≥ 18 years or legal adult age in the country). Informed consent forms and subject information sheets are available (document library includes multiple ICF and SIS files) in English and country/language-specific translations (examples in the dossier include French (FR), Romanian (RO) and English versions and other local language versions as provided per country).

Methods

  • GP letter (general practitioner invitation) - document types include GP letter files
  • Patient invitation letters (site-specific patient invitation letters noted for e.g., Goteborg, Lund, Orebro)
  • Advertisement materials: poster and flyer, advertisement text (document titles include Advertisement Poster and Flyer, Advertisement Text)
  • Recruitment brochures and patient invitation materials (document titles include Recruitment Brochure and Patient Invitation Letter)

Geography

Total Number Of Sites
44
Total Number Of Participants
219

Austria

Earliest CTIS Part Ii Submission Date
24-10-2024
Latest Decision Or Authorization Date
11-02-2026
Processing Time Days
475
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Medical University Of Graz
Department Name
Department of Internal Medicine, Division of Endocrinology and Diabetology
Contact Person Name
Julia Mader
Contact Person Email
julia.mader@medunigraz.at

Italy

Earliest CTIS Part Ii Submission Date
11-10-2024
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
490
Number Of Sites
5
Number Of Participants
7

Sites

Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Dipartimento Area medica Reparto di Endocrinologia
Contact Person Name
Valeria Grancini
Site Name
ASST Fatebenefratelli Sacco
Department Name
Malattie Endocrine e Diabetologia
Contact Person Name
Paolo Fiorina
Contact Person Email
Paolo.fiorina@unimi.it
Site Name
University Of Bari Aldo Moro
Department Name
UOC di Endocrinologia
Contact Person Name
Francesco Giorgino
Contact Person Email
f.giorgino@endo.uniba.it
Site Name
Universita' Degli Studi G. D'Annunzio Di Chieti
Department Name
Centro di Studi e tecnologie avanzate
Contact Person Name
Federica Carrieri
Contact Person Email
federica.carrieri@phd.unich.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
Contact Person Name
Uberto Pagotto
Contact Person Email
uberto.pagotto@unibo.it

Spain

Earliest CTIS Part Ii Submission Date
04-10-2024
Latest Decision Or Authorization Date
12-02-2026
Processing Time Days
496
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
Hospital Universitario De La Ribera
Department Name
Servicio de Endocrinologia
Contact Person Name
Carmen Fajardo Montañana
Contact Person Email
fajardo_carmon@gva.es
Site Name
Hospital Nisa Sevilla Aljarafe
Department Name
Unidad Salud CardioMetabólica Diabetes y Obesidad
Contact Person Name
Cristobal Jesus Morales Portillo
Contact Person Email
moralesPCJ@vithas.es
Site Name
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
Department Name
Servicio de Endocrinologia
Contact Person Name
Carolina Lopez Cano
Contact Person Email
karolopezc@gmail.com
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Servicio de Endocrinologia
Contact Person Name
Alfonso Soto Gonzalez
Contact Person Email
asotog30@yahoo.com
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Servicio de Endocrinologia
Contact Person Name
Francisco Jose Tinahones Madueño
Contact Person Email
fjtinahones@hotmail.com

Sweden

Earliest CTIS Part Ii Submission Date
14-10-2024
Latest Decision Or Authorization Date
10-02-2026
Processing Time Days
484
Number Of Sites
5
Number Of Participants
5

Sites

Site Name
Region Oerebro Laen
Department Name
Avdelningen for Kliniska Provningar
Contact Person Name
Martin Lundvall
Site Name
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name
Forskningsenheten
Contact Person Name
Zacharias Mandalenakis
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Endokrin
Contact Person Name
Katarina Fagher
Contact Person Email
katarina.fagher@med.lu.se
Site Name
Region Stockholm – SLSO
Department Name
Centrum for diabetes
Contact Person Name
Neda Rajamand Ekberg
Contact Person Email
neda.ekberg@ki.se
Site Name
Soedersjukhuset AB
Department Name
Internmedicin - Sektion Endokrinologi/Hematologi
Contact Person Name
Ingrid Dahlman

Romania

Earliest CTIS Part Ii Submission Date
14-10-2024
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
490
Number Of Sites
5
Number Of Participants
30

Sites

Site Name
Clinica Korall S.R.L.
Contact Person Name
Adriana Filimon
Contact Person Email
diabcaresm@gmail.com
Site Name
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti
Department Name
Sectia I Diabet
Contact Person Name
Cornelia Zetu
Contact Person Email
corapnc@yahoo.com
Site Name
Consultmed S.R.L.
Contact Person Name
Ella Pintilei
Contact Person Email
ellapintilei@yahoo.com
Site Name
Mariodiab Clinic S.R.L.
Contact Person Name
Brindusa Adriana Cofaru
Contact Person Email
drcofaru@gmail.com
Site Name
Hightech Medical Services S.R.L.
Contact Person Name
Ciprian Constantin
Contact Person Email
ciprian_constantin@yahoo.com

Poland

Earliest CTIS Part Ii Submission Date
10-10-2024
Latest Decision Or Authorization Date
16-02-2026
Processing Time Days
494
Number Of Sites
7
Number Of Participants
61

Sites

Site Name
Centrum Badan Klinicznych Piotr Napora Lekarze sp.p.
Contact Person Name
Piotr Napora
Contact Person Email
szpital@cbk.wroc.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Diabetology
Contact Person Name
Barbara Katra
Contact Person Email
metabol.diabetol@su.krakow.pl
Site Name
NBR POLSKA TOMASZ KŁODAWSKI
Contact Person Name
Katarzyna Klodawska
Contact Person Email
tomasz.klodawski@nbrpolska.pl
Site Name
Nowe Zdrowie-Ck Kieltucki I Wspolnicy Sp. j.
Contact Person Name
Jacek Kieltucki
Contact Person Email
startup@nowezdrowie-ck.pl
Site Name
Futuremeds Sp. z o.o.
Contact Person Name
Marcin Lewicki
Contact Person Email
marcin.lewicki@futuremeds.com
Site Name
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Department Name
Centre of Innovative Therapies
Contact Person Name
Beata Matyjaszek-Matuszek
Contact Person Email
cwbk@umlub.pl
Site Name
Nowe Zdrowie / other listed Polish sites

Hungary

Earliest CTIS Part Ii Submission Date
09-09-2024
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
522
Number Of Sites
10
Number Of Participants
63

Sites

Site Name
SYNEXUS Magyarorszag Kft.
Contact Person Name
Karoly Wittmann
Contact Person Email
karoly.wittmann@globalaes.com
Site Name
Obudai Egeszseguegyi Centrum Kft.
Contact Person Name
Timea Balo
Contact Person Email
timea.balo@oec.hu
Site Name
Szent Margit Rendelointezet Nonprofit Kft.
Contact Person Name
Timea Tanczer
Contact Person Email
tanczer.timea@gmail.com
Site Name
Borbanya Praxis Egeszsegugyi Kft.
Contact Person Name
Szilard Vasas
Contact Person Email
szilard.vasas@gmail.com
Site Name
CRU Hungary Kft.
Contact Person Name
Melinda Kovacs
Contact Person Email
mkovacs@cruint.com
Site Name
DRC Kft.
Contact Person Name
Laszlo Koranyi
Contact Person Email
laszlo.koranyi@drc.hu
Site Name
SYNEXUS Magyarorszag Kft. (second location)
Contact Person Name
Viktor Vass
Contact Person Email
viktor.vass@globalaes.com
Site Name
Lausmed Kft.
Contact Person Name
Laszlo Konyves
Contact Person Email
dr.konyves@gmail.com
Site Name
Clinexpert Kft.
Contact Person Name
Istvan Pall
Contact Person Email
pall_istvan@yahoo.com
Site Name
University Of Debrecen
Department Name
Belgyogyaszati Klinika
Contact Person Name
Denes Pall
Contact Person Email
pall.denes@gmail.com

Greece

Earliest CTIS Part Ii Submission Date
05-08-2024
Latest Decision Or Authorization Date
11-02-2026
Processing Time Days
555
Number Of Sites
6
Number Of Participants
29

Sites

Site Name
Athens Medical Center S.A.
Department Name
Diabetes Clinic and Clinical Research Center
Contact Person Name
John Doupis
Contact Person Email
john.doupis@harvard-alumni.org
Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
First Propaedeutic Department of Internal Medicine
Contact Person Name
Konstantinos Tziomalos
Contact Person Email
ktziomalos@yahoo.com
Site Name
Geniko Nosokomeio Peiraia Tzaneio
Department Name
1st Department of Internal Medicine and Diabetes Center
Contact Person Name
Athanasia Papazafiropoulou
Contact Person Email
athpapazafiropoulou@gmail.com
Site Name
Thermi Clinic S.A.
Department Name
Internal Medicine and Diabetes Department
Contact Person Name
Emmanouil Pagkalos
Contact Person Email
epagkalos@gmail.com
Site Name
Laiko General Hospital Of Athens
Department Name
1st department of propaedeutic Internal Medicine
Contact Person Name
Nikolaos Tentolouris
Contact Person Email
ntentolouris@yahoo.gr
Site Name
Athens Medical Center S.A. (Maroussi)
Department Name
Diabetes and Obesity Unit
Contact Person Name
Georgia Argyrakopoulou
Contact Person Email
gargyrakopoulou@gmail.com

Sponsor

Primary sponsor

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

Contract research organisations

Name
Excelya Greece CRO Single Member S.A.
Responsibilities
1
Name
Suvoda LLC
Responsibilities
3

Third parties

  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"1","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Canada","full_name":"Altasciences Compagnie Inc.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"India","full_name":"Syngene International Limited","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"7","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
AMG 133
Active Substance
MARIDEBART CAFRAGLUTIDE
Modality
Monoclonal antibody
Routes Of Administration
Subcutaneous
Route
Subcutaneous
Authorisation Status
MIA number 108520 F
Investigational Product Name
Placebo for AMG 133
Authorisation Status
MIA number 108520 F

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