Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
- Registration Number
- NCT06858839
- 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
- 3501
- Age ≥ 18 years.
- Body mass index ≥ 30 kg/m2 or ≥27 kg/m² to < 30 kg/m2 with at least 1 of the following weight-related comorbidities: hypertension, dyslipidemia, history of obstructive sleep apnea, history of cardiovascular disease, history of metabolic dysfunction-associated steatotic liver disease (MASLD) or Metabolic Dysfunction-Associated Steatohepatitis (MASH).
- History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
- Type 1 or Typ2 diabetes mellitus.
- Obesity induced by other endocrinologic disorders.
- Self-reported change in body weight > 5 kg within 90 days before screening.
- 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 Week 72 Participant achieving ≥ 10% reduction in body weight from baseline at week 72 Week 72 Participant achieving ≥ 15% reduction in body weight from baseline at week 72 Week 72 Participant achieving ≥ 20% reduction in body weight from baseline at week 72 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 Glucose at Week 72 Baseline and 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 The IWQOL-Lite-CT is a 20-item questionnaire designed to assess the impact of weight on quality of life in clinical trials. Items are scored on a 5-point Likert scale, with raw scores transformed to a 0-100 scale, where higher scores indicate better quality of life and less weight-related impact.
Change From Baseline in Body Weight at Week 72 Baseline and Week 72 Change From Baseline in Body Mass Index (BMI) at Week 72 Baseline and Week 72 Change From Baseline in Hemoglobin A1c at Week 72 Baseline and Week 72 Percent Change From Baseline in Fasting Insulin at Week 72 Baseline and Week 72 Change From Baseline in Glycemic Status at Week 72 Baseline and Week 72 Percent Change From Baseline in Fasting Lipid Parameters at Week 72 Baseline and Week 72 Lipid parameters include: total cholesterol, non-high-density lipoprotein cholesterol (non-HDL-C), low-density lipoprotein cholesterol (LDL-C), very-low-density lipoprotein cholesterol (VLDL-C), and high-density lipoprotein cholesterol (HDL-C).
Change From Baseline in Diastolic Blood Pressure (DBP) 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 Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72 Baseline and Week 72 The SF-36v2 Acute Physical Function domain score measures an individual's ability to perform daily physical activities, such as walking and climbing stairs, over the past week. It includes 10 items scored on a 3-point Likert scale, with raw scores transformed to a 0-100 scale. Higher scores indicate better physical functioning and fewer limitations due to physical health.
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) Up to approximately 88 weeks Plasma Concentration of Maridebart Cafraglutide at Week 72 Week 72
Related Research Topics
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Trial Locations
- Locations (102)
Indago Research and Health Center
🇺🇸Hialeah, Florida, United States
Yale School of Medicine
🇺🇸New Haven, Connecticut, United States
Pinnacle Research Group LLC
🇺🇸Anniston, Alabama, United States
Alliance For Multispecialty Research - Daphne
🇺🇸Daphne, Alabama, United States
Alliance for Multispecialty Research Mobile
🇺🇸Mobile, Alabama, United States
Avacare Foothills Research Center
🇺🇸Phoenix, Arizona, United States
Ark Clinical Research- Tustin
🇺🇸Fountain Valley, California, United States
Long Beach Clinical Trials Services Inc
🇺🇸Long Beach, California, United States
Ark Clinical Research- Long Beach
🇺🇸Long Beach, California, United States
Catalina Research Institute
🇺🇸Montclair, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Apex Clinical Research
🇺🇸San Diego, California, United States
Chase Medical Research LLC
🇺🇸Waterbury, Connecticut, United States
Southern California Clinical Research
🇺🇸Santa Ana, California, United States
Diablo Clinical Research
🇺🇸Walnut Creek, California, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Clinical Neuroscience Solutions - Jacksonville
🇺🇸Jacksonville, Florida, United States
South Florida Wellness and Clinical Research Institute
🇺🇸Margate, Florida, United States
Optimus U Corporation
🇺🇸Miami, Florida, United States
Research Institute of South Florida
🇺🇸Miami, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Clinical Neuroscience Solutions - Orlando
🇺🇸Orlando, Florida, United States
Combined Research Orlando Phase I IV
🇺🇸Orlando, Florida, United States
Florida Institute for Clinical Research
🇺🇸Orlando, Florida, United States
Encore Medical Research of Weston LLC
🇺🇸Weston, Florida, United States
Center for Advanced Research and Education
🇺🇸Gainesville, Georgia, United States
Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
🇺🇸Union City, Georgia, United States
East-West Medical Research
🇺🇸Honolulu, Hawaii, United States
Solaris Clinical Research
🇺🇸Meridian, Idaho, United States
Flourish Research - Great Lakes Clinical Trials
🇺🇸Chicago, Illinois, United States
Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie
🇺🇸Skokie, Illinois, United States
Evanston Premier Healthcare Research LLC
🇺🇸Skokie, Illinois, United States
Alliance for Multispecialty Research Newton
🇺🇸Newton, Kansas, United States
Louisville Metabolic and Atherosclerosis Research Center
🇺🇸Louisville, Kentucky, United States
Velocity Clinical Research - Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
Tandem Clinical Research - Marrero
🇺🇸Marrero, Louisiana, United States
Headlands Research - Detroit
🇺🇸Southfield, Michigan, United States
Prime Health and Wellness Sky Clinical Research Network Group
🇺🇸Fayette, Mississippi, 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
🇺🇸Las Vegas, Nevada, United States
Rochester Clinical Research
🇺🇸Rochester, New York, United States
Velocity Clinical Research - Vestal
🇺🇸Vestal, New York, United States
Accellacare of Hickory
🇺🇸Hickory, North Carolina, United States
Carolina Research Center Inc
🇺🇸Shelby, North Carolina, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Clinical Trial Investigator Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Velocity Clinical Research - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Alliance for Multispecialty Research - Norman
🇺🇸Norman, Oklahoma, United States
Capital Area Research LLC
🇺🇸Newport, Pennsylvania, United States
Velocity Clinical Research - Providence
🇺🇸East Greenwich, Rhode Island, United States
Tribe Clinical Research LLC Dba Mountain View Clinical Research
🇺🇸Greenville, South Carolina, United States
New Phase Research and Development
🇺🇸Knoxville, Tennessee, United States
Accellacare US Inc., d/b/a Accellacare of Knoxville
🇺🇸Knoxville, Tennessee, United States
Elligo Clinical Research Center
🇺🇸Austin, Texas, United States
Cedar Health Research, LLC
🇺🇸Euless, Texas, United States
Epic Medical Research - Texas
🇺🇸DeSoto, Texas, United States
Great Lakes Research Institute El Paso Research
🇺🇸El Paso, Texas, United States
Juno Research LLC
🇺🇸Houston, Texas, United States
Biopharma Informatic, LLC
🇺🇸Houston, Texas, United States
Southern Endocrinology Associates PA
🇺🇸Mesquite, Texas, United States
Great Lakes Research Institute - McAllen Research
🇺🇸Pharr, Texas, United States
Clinical Trials of Texas
🇺🇸San Antonio, Texas, United States
Sugar Lakes Family Practice
🇺🇸Sugar Land, Texas, United States
Pantheon Clinical Research
🇺🇸Bountiful, Utah, United States
Alliance for Multispecialty Research Layton Research Center
🇺🇸Layton, Utah, United States
Chrysalis Clinical Research, LLC
🇺🇸Saint George, Utah, United States
Washington Center for Weight Management and Research, Inc
🇺🇸Arlington, Virginia, United States
Health Research of Hampton Roads
🇺🇸Newport News, Virginia, United States
Selma Medical Associates
🇺🇸Winchester, Virginia, United States
Allegiance Research Specialists
🇺🇸Milwaukee, Wisconsin, United States
Emeritus Research Sydney
🇦🇺Botany, New South Wales, Australia
Novatrials
🇦🇺Kotara, New South Wales, Australia
Sutherland Shire Clinical Research
🇦🇺Miranda, New South Wales, Australia
Royal North Shore Hospital
🇦🇺St Leonards, New South Wales, Australia
Wollongong Clinical Research
🇦🇺Wollongong, New South Wales, Australia
Logan Hospital
🇦🇺Meadowbrook, Queensland, Australia
Fusion Clinical Research
🇦🇺Norwood, South Australia, Australia
Southern Adelaide Diabetes and Endocrine Services
🇦🇺Oaklands Park, South Australia, Australia
Altona Clinical Research
🇦🇺Altona North, Victoria, Australia
Emeritus Research Camberwell
🇦🇺Camberwell, Victoria, Australia
Austin Health, Heidelberg Repatriation Hospital
🇦🇺Heidelberg West, Victoria, Australia
tlc Diabetes and Endocrinology
🇨🇦Surrey, British Columbia, Canada
Wharton Medical Clinic
🇨🇦Hamilton, Ontario, Canada
North York Diagnostic and Cardiac Centre
🇨🇦North York, Ontario, Canada
Heart Health Institute Research Incorporated
🇨🇦Scarborough, Ontario, Canada
Centricity Research Toronto
🇨🇦Toronto, Ontario, Canada
Ecogene-21
🇨🇦Chicoutimi, Quebec, Canada
CardioVasc HR Incorporated
🇨🇦St Jean sur Richelieu, Quebec, Canada
Centre de Medecine Metabolique de Lanaudiere
🇨🇦Terrebonne, Quebec, Canada
Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic
🇯🇵Yokohama-shi, Kanagawa, Japan
Doujin Memorial Foundation, Meiwa Hospital
🇯🇵Chiyoda-ku, Tokyo, Japan
Tokyo Asbo Clinic
🇯🇵Chuo-ku, Tokyo, Japan
Medical Corp Seikoukai New Medical Research System Clinic
🇯🇵Hachioji-shi, Tokyo, Japan
Medical Corporation AOT Shinagawa Strings Clinic
🇯🇵Minato-ku, Tokyo, Japan
Clinical Research Hospital Tokyo
🇯🇵Shinjuku-ku, Tokyo, Japan
Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic
🇯🇵Suginami-ku, Tokyo, Japan
Ponce Medical School Foundation Inc
🇵🇷Ponce, Puerto Rico
Puerto Rico Medical Research Inc.
🇵🇷Ponce, Puerto Rico
Latin Clinical Trial Center
🇵🇷San Juan, Puerto Rico
Wellness Clinical Research Vega Baja
🇵🇷Vega Baja, Puerto Rico
Stoffwechselzentrum Sankt Gallen
🇨🇭Sankt Gallen, Switzerland