A Study of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus (T2DM)
- Conditions
- Interventions
- Registration Number
- NCT06660173
- Lead Sponsor
- Amgen
- Brief Summary
The main purpose of this study is to assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Maridebart Cafraglutide Maridebart Cafraglutide Participants will be randomized to receive maridebart cafraglutide at varying dose levels, or placebo, for up to 24 weeks. Participants who complete the 24-week main treatment period and meet specific criteria will have the option to begin an exploratory part 2 portion where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks. Placebo Placebo Participants will be randomized to receive maridebart cafraglutide at varying dose levels, or placebo, for up to 24 weeks. Participants who complete the 24-week main treatment period and meet specific criteria will have the option to begin an exploratory part 2 period where they will receive maridebart cafraglutide for an additional 24 weeks.
- Primary Outcome Measures
Name Time Method Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) Baseline to Week 24
- Secondary Outcome Measures
Name Time Method Percent Change From Baseline to Week 24 in Body Weight Baseline to Week 24 Number of Participants Achieving HbA1c < 7.0% at Week 24 Week 24 Number of Participants Achieving HbA1c ≤ 6.5% at Week 24 Week 24 Number of Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 24 Week 24 Number of Participants Achieving ≥ 10% Reduction in Body Weight From Baseline at Week 24 Week 24 Change From Baseline to Week 24 in Fasting Glucose Baseline to Week 24 Percent Change From Baseline to Week 24 in Total Cholesterol Baseline to Week 24 Percent Change From Baseline to Week 24 in Low-density Lipoprotein Cholesterol (LDL-C) Baseline to Week 24 Percent Change From Baseline to Week 24 in High-density Lipoprotein Cholesterol (HDL-C) Baseline to Week 24 Percent Change From Baseline to Week 24 in Non-high Density Lipoprotein Cholesterol (non-HDL-C) Baseline to Week 24 Percent Change From Baseline to Week 24 in Very-low-density Lipoprotein Cholesterol (VLDL-C) Baseline to Week 24 Percent Change From Baseline to Week 24 in Triglycerides Baseline to Week 24 Percent Change From Baseline to Week 24 in Free Fatty Acids (FFA) Baseline and Week 24 Change From Baseline to Week 24 in Systolic Blood Pressure Baseline and Week 24 Change From Baseline to Week 24 in Diastolic Blood Pressure Baseline and Week 24 Pre-dose Plasma Concentration of Maridebart Cafraglutide at Week 20 Week 20 Maximum Observed Plasma Concentration of Maridebart Cafraglutide at Week 20 Week 20 Number of Participants with Treatment Emergent Adverse Events Up to 24 Weeks Number of Participants with Serious Adverse Events Up to 24 Weeks Number of Participants with Anti-maridebart Cafraglutide Antibody Formation Up to Week 24
Trial Locations
- Locations (73)
New Horizon Research Center
🇺🇸Miami, Florida, United States
Florida Institute for Clinical Research
🇺🇸Orlando, Florida, United States
Conquest Research - Winter Park
🇺🇸Winter Park, Florida, United States
Accel Research Site - Neurostudies
🇺🇸Decatur, Georgia, United States
Cedar Crosse Research and Health Care
🇺🇸Chicago, Illinois, United States
Tandem Clinical Research - Marrero
🇺🇸Marrero, Louisiana, United States
DM Clinical - Detroit
🇺🇸Southfield, Michigan, United States
Physicians East
🇺🇸Greenville, North Carolina, United States
Diabetes and Endocrinology Associates of Stark County Inc
🇺🇸Canton, Ohio, United States
Alliance for Multispecialty Research
🇺🇸Norman, Oklahoma, United States
Morinaga Ueno Clinic
🇯🇵Kumamoto-shi, Kumamoto, Japan
Midori Clinic
🇯🇵Nagasaki-shi, Nagasaki, Japan
Shiraiwa Medical Clinic
🇯🇵Kashiwara-shi, Osaka, Japan
Plumeria DM Clinic
🇯🇵Shizuoka-shi, Shizuoka, Japan
Yutenji Medical Clinic
🇯🇵Meguro-ku, Tokyo, Japan
Accel Research Site - Birmingham Clinical Research Unit
🇺🇸Birmingham, Alabama, United States
Anaheim Clinical Trials
🇺🇸Anaheim, California, United States
Orange County Research Center
🇺🇸Lake Forest, California, United States
San Jose Clinical Trials
🇺🇸San Jose, California, United States
Northeast Research Institute - Neri
🇺🇸Fleming Island, Florida, United States
Trial Management Associates - Myrtle Beach
🇺🇸Myrtle Beach, South Carolina, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
Velocity Clinical Research - Dallas
🇺🇸Dallas, Texas, United States
DM Clinical Research - Cyfair Clinical Research Center
🇺🇸Houston, Texas, United States
Southern Endocrinology Associates PA
🇺🇸Mesquite, Texas, United States
Be Well Clinical Studies
🇺🇸Round Rock, Texas, United States
Diabetes and Glandular Disease Clinic
🇺🇸San Antonio, Texas, United States
DM Clinical Research - Martin Diagnostic Clinic
🇺🇸Tomball, Texas, United States
Manassas Clinical Research Center Inc
🇺🇸Manassas, Virginia, United States
Medizinische Universitaet Graz
🇦🇹Graz, Austria
Athens Medical Center S.A - Iatriko Amarousiou
🇬🇷Maroussi, Greece
Athens Medical Center- Iatriko Paleou Falirou
🇬🇷Palaio Faliro, Greece
Geniko Nosokomeio Peiraia Tzaneio
🇬🇷Piraeus, Greece
General Hospital of Thessaloniki Ahepa
🇬🇷Thessaloniki, Greece
Thermi Clinic S.A.
🇬🇷Thessaloniki, Greece
Queen Mary Hospital / HKU
🇭🇰Hong Kong, Hong Kong
Lausmed Kft
🇭🇺Baja, Hungary
Drug Research Center Kft
🇭🇺Balatonfured, Hungary
Szent Margit Rendelointezet Diabetologiai Ambulancia
🇭🇺Budapest, Hungary
Clinexpert Kft
🇭🇺Budapest, Hungary
Obudai Egeszsegugyi Centrum Kft
🇭🇺Budapest, Hungary
Synexus Magyarorszag Egeszsegugyi Szolgaltato Kft
🇭🇺Zalaegerszeg, Hungary
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hungary
CRU Hungary Kft
🇭🇺Encs, Hungary
Borbanya Praxis Egeszsegugyi Kft
🇭🇺Nyiregyhaza, Hungary
Kunisaki Makoto Clinic
🇯🇵Fukuoka-shi, Fukuoka, Japan
Nakamoto Medical Clinic
🇯🇵Mito-shi, Ibaraki, Japan
Ohishi Naika Clinic
🇯🇵Tsuchiura-shi, Ibaraki, Japan
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Severance Hospital Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea Seoul St Marys Hospital
🇰🇷Seoul, Korea, Republic of
Nzoz Specjalistyczny Osrodek Internistyczno-Diabetologiczny Malgorzata Arciszewska
🇵🇱Bialystok, Poland
Uniwersytecki Szpital Kliniczny numer 4 Centrum Innowacyjnych Terapii
🇵🇱Lublin, Poland
Nowe Zdrowie-Ck Kieltucki i Wspolnicy Spolka Jawna
🇵🇱Staszow, Poland
Nbr Polska Tomasz Klodawski
🇵🇱Warszawa, Poland
Centrum Badan Klinicznych Piotr Napora lekarze spolka partnerska
🇵🇱Wroclaw, Poland
Futuremeds spolka z ograniczona odpowiedzialnoscia
🇵🇱Wroclaw, Poland
Latin Clinical Trial Center
🇵🇷San Juan, Puerto Rico
Centrul pentru Studiul Metabolismului - Hightech Medical Services SRL
🇷🇴Bucharest, Romania
Consultmed SRL
🇷🇴Iasi, Romania
Hospital Vithas Sevilla
🇪🇸Castilleja de la Cuesta, Andalucía, Spain
Hospital Clinico Universitario Virgen de la Victoria
🇪🇸Malaga, Andalucía, Spain
Hospital Universitario Arnau de Vilanova Lleida
🇪🇸Lleida, Cataluña, Spain
Complexo Hospitalario Universitario A Coruña
🇪🇸A Coruña, Galicia, Spain
Ostra Sjukhuset
🇸🇪Goteborg, Sweden
Skanes universitetssjukhus
🇸🇪Lund, Sweden
Universitetssjukhuset Orebro
🇸🇪Orebro, Sweden
Sabbatsbergs Sjukhus
🇸🇪Stockholm, Sweden
Sodersjukhuset
🇸🇪Stockholm, Sweden
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan