Clinical trial NCT06660173: A Study of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus (T2DM)
Official title: A Study to Evaluate the Efficacy, Safety & Tolerability of Maridebart Cafraglutide in Adults With T2DM
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: Obesity
AMG 133
T2DM
Hemoglobin A1C (HbA1c)
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2024-10-28
Enrollment: 409
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years at screening (or ≥ legal age within the country if it is older than 18 years)
* Type 2 diabetes for ≥6 months according to the World Health Organization classification
* HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory
* Treatment of diabetes with diet and exercise alone, or with a stable dose of metformin, with or without a sodium-glucose cotransporter-2 inhibitor, for at least 3 months prior to screening
* Body mass index of 23 to 50 kilograms per square meter

Exclusion Criteria:

* Type 1 diabetes
* Use of any glucose-lowering medication, other than metformin with or without a sodium-glucose cotransporter-2 inhibitor, within 3 months prior to screening
* Estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology equation.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy
* History of acute or chronic pancreatitis
* Malignancy within 5 years before screening, except for nonmelanoma skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer
* Myocardial infarction, unstable angina, coronary artery bypass graft surgery or other major cardiovascular surgery, percutaneous coronary intervention, transient ischemic attack, cerebrovascular accident, or decompensated congestive heart failure within 90 days prior to screening, or currently have New York Heart Association Class III or IV heart failure.
* Use of medications that affect glucose control or body weight or history of bariatric surgery or procedures.

Primary outcomes:
measure: Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Percent Change From Baseline to Week 24 in Body Weight
timeFrame: Baseline to Week 24
measure: Number of Participants Achieving HbA1c < 7.0% at Week 24
timeFrame: Week 24
measure: Number of Participants Achieving HbA1c ≤ 6.5% at Week 24
timeFrame: Week 24
measure: Number of Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 24
timeFrame: Week 24
measure: Number of Participants Achieving ≥ 10% Reduction in Body Weight From Baseline at Week 24
timeFrame: Week 24
measure: Change From Baseline to Week 24 in Fasting Glucose
timeFrame: Baseline to Week 24
measure: Percent Change From Baseline to Week 24 in Total Cholesterol
timeFrame: Baseline to Week 24
measure: Percent Change From Baseline to Week 24 in Low-density Lipoprotein Cholesterol (LDL-C)
timeFrame: Baseline to Week 24
measure: Percent Change From Baseline to Week 24 in High-density Lipoprotein Cholesterol (HDL-C)
timeFrame: Baseline to Week 24
measure: Percent Change From Baseline to Week 24 in Non-high Density Lipoprotein Cholesterol (non-HDL-C)
timeFrame: Baseline to Week 24
measure: Percent Change From Baseline to Week 24 in Very-low-density Lipoprotein Cholesterol (VLDL-C)
timeFrame: Baseline to Week 24
measure: Percent Change From Baseline to Week 24 in Triglycerides
timeFrame: Baseline to Week 24
measure: Percent Change From Baseline to Week 24 in Free Fatty Acids (FFA)
timeFrame: Baseline and Week 24
measure: Change From Baseline to Week 24 in Systolic Blood Pressure
timeFrame: Baseline and Week 24
measure: Change From Baseline to Week 24 in Diastolic Blood Pressure
timeFrame: Baseline and Week 24
measure: Change from Baseline to Week 24 in High-sensitivity C-reactive Protein
timeFrame: Baseline and Week 24
measure: Pre-dose Plasma Concentration of Maridebart Cafraglutide at Week 20
timeFrame: Week 20
measure: Maximum Observed Plasma Concentration of Maridebart Cafraglutide at Week 20
timeFrame: Week 20
measure: Number of Participants with Treatment Emergent Adverse Events
timeFrame: Up to 24 Weeks
measure: Number of Participants with Serious Adverse Events
timeFrame: Up to 24 Weeks
measure: Number of Participants with Anti-maridebart Cafraglutide Antibody Formation
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Accel Research Site - Birmingham Clinical Research Unit
state: Alabama
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Canoga Park
country: United States
facility: Hope Clinical Research LLC
state: California
city: Lake Forest
country: United States
facility: Orange County Research Center
state: California
city: San Jose
country: United States
facility: San Jose Clinical Trials
state: California
city: Fleming Island
country: United States
facility: Northeast Research Institute - Neri
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Orlando
country: United States
facility: Florida Institute for Clinical Research
state: Florida
city: Winter Park
country: United States
facility: Conquest Research - Winter Park
state: Florida
city: Decatur
country: United States
facility: Accel Research Site - Neurostudies
state: Georgia
city: Chicago
country: United States
facility: Cedar Crosse Research and Health Care
state: Illinois
city: Marrero
country: United States
facility: Tandem Clinical Research - Marrero
state: Louisiana
city: Southfield
country: United States
facility: DM Clinical - Detroit
state: Michigan
city: Missoula
country: United States
facility: Montana Medical Research
state: Montana
city: Greenville
country: United States
facility: Physicians East
state: North Carolina
city: Canton
country: United States
facility: Diabetes and Endocrinology Associates of Stark County Inc
state: Ohio
city: Norman
country: United States
facility: Alliance for Multispecialty Research
state: Oklahoma
city: Myrtle Beach
country: United States
facility: Trial Management Associates - Myrtle Beach
state: South Carolina
city: Austin
country: United States
facility: FutureSearch Trials of Neurology
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Research - Dallas
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - Cyfair Clinical Research Center
state: Texas
city: Mesquite
country: United States
facility: Southern Endocrinology Associates PA
state: Texas
city: Round Rock
country: United States
facility: Be Well Clinical Studies
state: Texas
city: San Antonio
country: United States
facility: Diabetes and Glandular Disease Clinic
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - Martin Diagnostic Clinic
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research Center
state: Virginia
city: Manassas
country: United States
facility: Manassas Clinical Research Center Inc
state: Virginia
city: Redmond
country: United States
facility: Eastside Research Associates Health Research
state: Washington
city: Graz
country: Austria
facility: Medizinische Universitaet Graz
city: Linz
country: Austria
facility: Krankenhaus der Barmherzigen Brueder Linz
city: Wien
country: Austria
facility: Universitaetsklinikum Allgemeines Krankenhaus Wien
city: Wien
country: Austria
facility: Klinik Hietzing
city: Athens
country: Greece
facility: Laiko General Hospital of Athens
city: Maroussi
country: Greece
facility: Athens Medical Center S.A - Iatriko Amarousiou
city: Palaio Faliro
country: Greece
facility: Athens Medical Center- Iatriko Paleou Falirou
city: Piraeus
country: Greece
facility: Geniko Nosokomeio Peiraia Tzaneio
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki Ahepa
city: Thessaloniki
country: Greece
facility: Thermi Clinic S.A.
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital, The University of Hong Kong
city: Baja
country: Hungary
facility: Lausmed Kft
city: Balatonfured
country: Hungary
facility: Drug Research Center Kft
city: Budapest
country: Hungary
facility: Szent Margit Rendelointezet Diabetologiai Ambulancia
city: Budapest
country: Hungary
facility: Clinexpert Kft
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft
city: Budapest
country: Hungary
facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Encs
country: Hungary
facility: CRU Hungary Kft
city: Nyiregyhaza
country: Hungary
facility: Borbanya Praxis Egeszsegugyi Kft
city: Zalaegerszeg
country: Hungary
facility: Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft
city: Bari
country: Italy
facility: Azienda Universitaria Ospedaliera Consorziale Policlinico Bari
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant Orsola
city: Chieti
country: Italy
facility: Universita degli Studi Gabriele D Annunzio di Chieti e Pescara
city: Milano
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
city: Milano
country: Italy
facility: Azienda Socio Sanitaria Territoriale Fatebenefratelli Sacco
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele
city: Fukuoka-shi
country: Japan
facility: Kunisaki Makoto Clinic
state: Fukuoka
city: Mito-shi
country: Japan
facility: Nakamoto Medical Clinic
state: Ibaraki
city: Tsuchiura-shi
country: Japan
facility: Ohishi Naika Clinic
state: Ibaraki
city: Kumamoto-shi
country: Japan
facility: Morinaga Ueno Clinic
state: Kumamoto
city: Nagasaki-shi
country: Japan
facility: Midori Clinic
state: Nagasaki
city: Kashiwara-shi
country: Japan
facility: Shiraiwa Medical Clinic
state: Osaka
city: Shizuoka-shi
country: Japan
facility: Plumeria DM Clinic
state: Shizuoka
city: Meguro-ku
country: Japan
facility: Yutenji Medical Clinic
state: Tokyo
city: Seongnam-si, Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Seoul St Marys Hospital
city: Bialystok
country: Poland
facility: Nzoz Specjalistyczny Osrodek Internistyczno-Diabetologiczny Malgorzata Arciszewska
city: Krakow
country: Poland
facility: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
city: Lublin
country: Poland
facility: Uniwersytecki Szpital Kliniczny numer 4 Centrum Innowacyjnych Terapii
city: Staszow
country: Poland
facility: Nowe Zdrowie-Ck Kieltucki i Wspolnicy Spolka Jawna
city: Warszawa
country: Poland
facility: Nbr Polska Tomasz Klodawski
city: Wroclaw
country: Poland
facility: Centrum Badan Klinicznych Piotr Napora lekarze spolka partnerska
city: Wroclaw
country: Poland
facility: Futuremeds spolka z ograniczona odpowiedzialnoscia
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
city: Brasov
country: Romania
facility: Mariodiab Clinic SRL
city: Bucharest
country: Romania
facility: Centrul pentru Studiul Metabolismului - Hightech Medical Services SRL
city: Bucuresti
country: Romania
facility: Institutul National de Diabet si Nutritie si Boli Metabolice N C Paulescu
city: Iasi
country: Romania
facility: Consultmed SRL
city: Satu Mare
country: Romania
facility: Clinica Korall
city: Castilleja de la Cuesta
country: Spain
facility: Hospital Vithas Sevilla
state: Andalucía
city: Malaga
country: Spain
facility: Hospital Clinico Universitario Virgen de la Victoria
state: Andalucía
city: Lleida
country: Spain
facility: Hospital Universitario Arnau de Vilanova Lleida
state: Cataluña
city: Alzira
country: Spain
facility: Hospital Universitario de La Ribera
state: Comunidad Valenciana
city: A Coruña
country: Spain
facility: Complexo Hospitalario Universitario A Coruña
state: Galicia
city: Goteborg
country: Sweden
facility: Ostra Sjukhuset
city: Lund
country: Sweden
facility: Skanes universitetssjukhus
city: Orebro
country: Sweden
facility: Universitetssjukhuset Orebro
city: Stockholm
country: Sweden
facility: Sabbatsbergs Sjukhus
city: Stockholm
country: Sweden
facility: Sodersjukhuset
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: