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Purpose

The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.

Condition

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Maridebart Cafraglutide High Dose 		Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks.
  • Drug: Maridebart Cafraglutide
    Maridebart cafraglutide will be administered SC.
    Other names:
    • AMG 133
    • MariTide
Experimental
Maridebart Cafraglutide Medium Dose 		Participants will receive maridebart cafraglutide medium dose SC for 72 weeks.
  • Drug: Maridebart Cafraglutide
    Maridebart cafraglutide will be administered SC.
    Other names:
    • AMG 133
    • MariTide
Experimental
Maridebart Cafraglutide Low Dose 		Participants will receive maridebart cafraglutide low dose SC for 72 weeks.
  • Drug: Maridebart Cafraglutide
    Maridebart cafraglutide will be administered SC.
    Other names:
    • AMG 133
    • MariTide
Placebo Comparator
Placebo 		Participants will receive placebo SC for 72 weeks.
  • Drug: Placebo
    Placebo will be administered SC.

Recruiting Locations

Pinnacle Research Group LLC
Anniston, Alabama 36207

Alliance For Multispecialty Research - Daphne
Daphne, Alabama 36526

Alliance for Multispecialty Research Mobile
Mobile, Alabama 36608

Avacare Foothills Research Center
Phoenix, Arizona 85044

Ark Clinical Research- Tustin
Fountain Valley, California 92708

Long Beach Clinical Trials Services Inc
Long Beach, California 90806

Ark Clinical Research- Long Beach
Long Beach, California 90815

Catalina Research Institute
Montclair, California 91763

Artemis Institute for Clinical Research
Riverside, California 92503

Artemis Institute for Clinical Research
San Diego, California 92103

Apex Clinical Research
San Diego, California 92120

Southern California Clinical Research
Santa Ana, California 92701

Diablo Clinical Research
Walnut Creek, California 94598

Yale School of Medicine
New Haven, Connecticut 06520

Chase Medical Research LLC
Waterbury, Connecticut 06708

Indago Research and Health Center
Hialeah, Florida 33012

Jacksonville Center for Clinical Research
Jacksonville, Florida 32216

Clinical Neuroscience Solutions - Jacksonville
Jacksonville, Florida 32256

South Florida Wellness and Clinical Research Institute
Margate, Florida 33063

Optimus U Corporation
Miami, Florida 33135

Research Institute of South Florida
Miami, Florida 33173

Renstar Medical Research
Ocala, Florida 34470

Clinical Neuroscience Solutions - Orlando
Orlando, Florida 32801

Combined Research Orlando Phase I IV
Orlando, Florida 32807

Florida Institute for Clinical Research
Orlando, Florida 32825

Encore Medical Research of Weston LLC
Weston, Florida 33331

Center for Advanced Research and Education
Gainesville, Georgia 30501

Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
Union City, Georgia 30291

East-West Medical Research
Honolulu, Hawaii 96814

Solaris Clinical Research
Meridian, Idaho 83646

Flourish Research - Great Lakes Clinical Trials
Chicago, Illinois 60640

Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie
Skokie, Illinois 60077

Evanston Premier Healthcare Research LLC
Skokie, Illinois 60077

Alliance for Multispecialty Research Newton
Newton, Kansas 67114

Louisville Metabolic and Atherosclerosis Research Center
Louisville, Kentucky 40213

Velocity Clinical Research - Baton Rouge
Baton Rouge, Louisiana 70809

Tandem Clinical Research - Marrero
Marrero, Louisiana 70072

Headlands Research - Detroit
Southfield, Michigan 48034

Prime Health and Wellness Sky Clinical Research Network Group
Fayette, Mississippi 39069

Alliance for Multispecialty Research - Kansas City
Kansas City, Missouri 64114

Palm Research Center Inc
Las Vegas, Nevada 89128

Vector Clinical Trials
Las Vegas, Nevada 89128

Rochester Clinical Research
Rochester, New York 14609

Velocity Clinical Research - Vestal
Vestal, New York 13850

Accellacare of Hickory
Hickory, North Carolina 28601

Carolina Research Center Inc
Shelby, North Carolina 28150

Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157

Clinical Trial Investigator Clinical Research Center
Cincinnati, Ohio 45212

Velocity Clinical Research - Cincinnati
Cincinnati, Ohio 45219

Alliance for Multispecialty Research - Norman
Norman, Oklahoma 73069

Capital Area Research LLC
Newport, Pennsylvania 17074

Velocity Clinical Research - Providence
East Greenwich, Rhode Island 02818

Tribe Clinical Research LLC Dba Mountain View Clinical Research
Greenville, South Carolina 29607

New Phase Research and Development
Knoxville, Tennessee 37909

Accellacare US Inc., d/b/a Accellacare of Knoxville
Knoxville, Tennessee 37938

Elligo Clinical Research Center
Austin, Texas 78704

Cedar Health Research, LLC
Dallas, Texas 75251

Epic Medical Research - Texas
DeSoto, Texas 75115

Great Lakes Research Institute El Paso Research
El Paso, Texas 79936

Cedar Health Research, LLC
Euless, Texas 76040

Juno Research LLC
Houston, Texas 77040

Biopharma Informatic, LLC
Houston, Texas 77043

Juno Research LLC
Houston, Texas 77054

Southern Endocrinology Associates PA
Mesquite, Texas 75149

Great Lakes Research Institute - McAllen Research
Pharr, Texas 78557

Clinical Trials of Texas
San Antonio, Texas 78229

Sugar Lakes Family Practice
Sugar Land, Texas 77479

Pantheon Clinical Research
Bountiful, Utah 84010

Alliance for Multispecialty Research Layton Research Center
Layton, Utah 84041

Chrysalis Clinical Research, LLC
Saint George, Utah 84770

Washington Center for Weight Management and Research, Inc
Arlington, Virginia 22206

Health Research of Hampton Roads
Newport News, Virginia 23606

Selma Medical Associates
Winchester, Virginia 22601

Allegiance Research Specialists
Milwaukee, Wisconsin 53226

Ponce Medical School Foundation Inc
Ponce, Puerto Rico 00716

Puerto Rico Medical Research Inc.
Ponce, Puerto Rico 00717

Latin Clinical Trial Center
San Juan, Puerto Rico 00909

Wellness Clinical Research Vega Baja
Vega Baja, Puerto Rico 00694

More Details

NCT ID
NCT06858839
Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com

Notice

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