Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
- Conditions
- Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
- Interventions
- Drug: Placebo
- Registration Number
- NCT06858878
- Lead Sponsor
- Amgen
- Brief Summary
The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 999
- Age ≥ 18 years.
- Body mass index ≥ 27 kg/m^2.
- History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
- Diagnosis of T2DM.
- Type 1 diabetes mellitus.
- Self-reported change in body weight > 5 kg within 90 days before screening.
- Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment.
- Obesity induced by other endocrinologic disorders.
- Family (first-degree relative[s]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.
- History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
- History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
- Lifetime history of suicide attempt.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Maridebart Cafraglutide High Dose Maridebart cafraglutide Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks. Maridebart Cafraglutide Medium Dose Maridebart cafraglutide Participants will receive maridebart cafraglutide medium dose SC for 72 weeks. Maridebart Cafraglutide Low Dose Maridebart cafraglutide Participants will receive maridebart cafraglutide low dose SC for 72 weeks. Placebo Placebo Participants will receive placebo SC for 72 weeks.
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight at Week 72 Baseline and Week 72
- Secondary Outcome Measures
Name Time Method Change from Baseline in Waist Circumference at Week 72 Baseline and Week 72 Participant achieving ≥ 5% reduction in body weight from baseline at week 72 Baseline and Week 72 Participant achieving ≥ 10% reduction in body weight from baseline at week 72 Baseline and Week 72 Participant achieving ≥ 15% reduction in body weight from baseline at week 72 Baseline and Week 72 Change from Baseline in Systolic Blood Pressure (SBP) at Week 72 Baseline and Week 72 Percent Change from Baseline in Fasting Triglycerides at Week 72 Baseline and Week 72 Change from Baseline in Fasting Plasma Glucose at Week 72 Baseline and Week 72 Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72 Baseline and Week 72 Participant achieving HbA1c < 7% at week 72 Week 72 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 Baseline and Week 72 Change from Baseline in Body Weight at Week 72 Baseline and Week 72 Participant achieving ≥ 20% reduction in body weight from baseline at week 72 Baseline and Week 72 Change from Baseline in Body Mass Index (BMI) at Week 72 Baseline and Week 72 Participant achieving HbA1c ≤ 6.5% at week 72 Week 72 Participant achieving HbA1c < 5.7%, at week 72 Week 72 Percent Change from Baseline in Fasting Insulin at Week 72 Baseline and Week 72 Percent Change from Baseline in High-sensitivity C-reactive Protein (hs-CRP) at Week 72 Baseline and Week 72 Change from Baseline in Urine Albumin-to-creatinine Ratio (uACR) at Week 72 Baseline and Week 72 Percent Change from Baseline at Week 72 in Fasting Concentration of Total Cholesterol Baseline and Week 72 Percent Change from Baseline at Week 72 in Fasting Concentration of Non-high-density Lipoprotein Cholesterol (non-HDL-C) Baseline and Week 72 Percent Change from Baseline at Week 72 in Fasting Concentration of Low-density Lipoprotein Cholesterol (LDL-C) Baseline and Week 72 Percent Change from Baseline at Week 72 in Fasting Concentration of Very-low-density Lipoprotein Cholesterol (VLDL-C) Baseline and Week 72 Percent Change from Baseline at Week 72 in Fasting Concentration of High-density Lipoprotein Cholesterol (HDL-C) Baseline and Week 72 Change from Baseline in Diastolic Blood Pressure DBP at Week 72 Baseline and Week 72 Change from Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72 Baseline and Week 72 Number of Participants who Experienced Treatment-emergent Adverse Events Up to Week 84 Number of Participants who Experienced Serious Adverse Events Up to Week 84 Plasma Concentration of Maridebart Cafraglutide at Week 72 Week 72
Related Research Topics
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Trial Locations
- Locations (72)
Alliance for Multispecialty Research Mobile
🇺🇸Mobile, Alabama, United States
Gilbert Center for Family Medicine
🇺🇸Gilbert, Arizona, United States
Desert Clinical Research
🇺🇸Mesa, Arizona, United States
Avacare Foothills Research Center
🇺🇸Phoenix, Arizona, United States
San Fernando Valley Health Institute
🇺🇸Canoga Park, California, United States
Core Healthcare Group
🇺🇸Cerritos, California, United States
Velocity Clinical Research Chula Vista
🇺🇸Chula Vista, California, United States
Headlands Research California
🇺🇸Escondido, California, United States
Paradigm Clinical Research
🇺🇸Modesto, California, United States
Flourish Research
🇺🇸Northridge, California, United States
University of California Irvine
🇺🇸Orange, California, United States
Empire Clinical Research
🇺🇸Pomona, California, United States
Infinity Clinical Trials
🇺🇸San Diego, California, United States
Greenwich Clinical Trials
🇺🇸Riverside, Connecticut, United States
Indago Research and Health Center
🇺🇸Hialeah, Florida, United States
San Marcus Research Clinic Inc
🇺🇸Miami Lakes, Florida, United States
Iowa Diabetes Research
🇺🇸West Des Moines, Iowa, United States
Optimus U Corporation
🇺🇸Miami, Florida, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Florida Institute for Clinical Research
🇺🇸Orlando, Florida, United States
Encore Medical Research of Weston LLC
🇺🇸Weston, Florida, United States
Conquest Research - Winter Park
🇺🇸Winter Park, Florida, United States
Alliance For Multispecialty Research - Oak Brook
🇺🇸Oak Brook, Illinois, United States
Indiana Medical Research Institute
🇺🇸Merrillville, Indiana, United States
Alliance for Multispecialty Research, LLC - Park Ridge
🇺🇸Park Ridge, Illinois, United States
Velocity Clinical Research - Springdale
🇺🇸Cincinnati, Ohio, United States
Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie
🇺🇸Skokie, Illinois, United States
Alliance for Multispecialty Research Newton
🇺🇸Newton, Kansas, United States
Alliance for Multispecialty Research LLC
🇺🇸Wichita, Kansas, United States
Ima Clinical Research- Monroe
🇺🇸Monroe, Louisiana, United States
Advanced Internal Medicine
🇺🇸Paducah, Kentucky, United States
Annapolis Internal Medicine, LLC
🇺🇸Annapolis, Maryland, United States
International Diabetes Center - HealthPartners Institute
🇺🇸Minneapolis, Minnesota, United States
Alliance for Multispecialty Research - Kansas City
🇺🇸Kansas City, Missouri, United States
Palm Research Center Inc
🇺🇸Las Vegas, Nevada, United States
Vector Clinical Trials
🇺🇸Sparks, Nevada, United States
Premier Research
🇺🇸Trenton, New Jersey, United States
Albany Medical College
🇺🇸Albany, New York, United States
Asheville Clinical Research
🇺🇸Asheville, North Carolina, United States
Physicians East
🇺🇸Greenville, North Carolina, United States
Carteret Medical Group
🇺🇸Morehead City, North Carolina, United States
West Clinical Research
🇺🇸Morehead City, North Carolina, United States
Velocity Clinical Research - Cincinnati
🇺🇸Blue Ash, Ohio, United States
Velocity Clinical Research - Providence
🇺🇸East Greenwich, Rhode Island, United States
Medical Care LLC
🇺🇸Elizabethton, Tennessee, United States
Elligo Clinical Research Center
🇺🇸Austin, Texas, United States
Osvaldo A Brusco MD PA
🇺🇸Corpus Christi, Texas, United States
Cedar Health Research, LLC
🇺🇸Euless, Texas, United States
Soma Clinical Trials, LLC
🇺🇸Denison, Texas, United States
Juno Research LLC
🇺🇸Houston, Texas, United States
Tekton Research
🇺🇸McKinney, Texas, United States
Northeast Clinical Research of San Antonio LLC
🇺🇸San Antonio, Texas, United States
Alliance for Multispecialty Research - Layton
🇺🇸Layton, Utah, United States
Manassas Clinical Research Center Inc
🇺🇸Manassas, Virginia, United States
Ima Clinical Research - West Virginia
🇺🇸Morgantown, West Virginia, United States
tlc Diabetes and Endocrinology
🇨🇦Surrey, British Columbia, Canada
Premier Clinical Trial Network
🇨🇦Hamilton, Ontario, Canada
Your Research Network Inc.
🇨🇦Niagara Falls, Ontario, Canada
North York Diagnostic and Cardiac Centre
🇨🇦North York, Ontario, Canada
Centricity Research Pointe-Claire
🇨🇦Pointe-Claire, Quebec, Canada
Mikannohana Clinic, Diabetes, Endocrinology and Metabolism
🇯🇵Matsuyama-shi, Ehime, Japan
Morizono Medical Clinic
🇯🇵Kitakyusyu-shi, Fukuoka, Japan
Mazda Hospital of Mazda Motor Corporation
🇯🇵Aki-gun, Hiroshima, Japan
Nakamoto Medical Clinic
🇯🇵Mito-shi, Ibaraki, Japan
Nakakinen Clinic
🇯🇵Naka-shi, Ibaraki, Japan
Ohishi Naika Clinic
🇯🇵Tsuchiura-shi, Ibaraki, Japan
Morinaga Ueno Clinic
🇯🇵Kumamoto-shi, Kumamoto, Japan
Shiraiwa Medical Clinic
🇯🇵Kashiwara-shi, Osaka, Japan
Suruga Clinic
🇯🇵Shizuoka-shi, Shizuoka, Japan
Yutenji Medical Clinic
🇯🇵Meguro-ku, Tokyo, Japan
Medical Corporation Ouitsukai Kanno Naika
🇯🇵Mitaka-shi, Tokyo, Japan
Latin Clinical Trial Center
🇵🇷San Juan, Puerto Rico