Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

Purpose

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

Condition

  • Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight

Eligibility

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

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

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 adminstered 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 adminstered 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 adminstered SC.
    Other names:
    • AMG 133
    • MariTide
Placebo Comparator
Placebo 		Participants will receive placebo SC for 72 weeks.
  • Drug: Placebo
    Placebo will be adminstered SC.

Recruiting Locations

Alliance for Multispecialty Research Mobile
Mobile, Alabama 36608

Gilbert Center for Family Medicine
Gilbert, Arizona 85296

Desert Clinical Research
Mesa, Arizona 85213

Avacare Foothills Research Center
Phoenix, Arizona 85044

San Fernando Valley Health Institute
Canoga Park, California 91304

Core Healthcare Group
Cerritos, California 90703

Velocity Clinical Research Chula Vista
Chula Vista, California 91911

Headlands Research California
Escondido, California 92025

Paradigm Clinical Research
Modesto, California 95355

Flourish Research
Northridge, California 91325

University of California Irvine
Orange, California 92868

Empire Clinical Research
Pomona, California 91767

Infinity Clinical Trials
San Diego, California 92108

Greenwich Clinical Trials
Riverside, Connecticut 06878

Indago Research and Health Center
Hialeah, Florida 33012

San Marcus Research Clinic Inc
Miami Lakes, Florida 33014

Optimus U Corporation
Miami, Florida 33135

New Horizon Research Center
Miami, Florida 33165

Florida Institute for Clinical Research
Orlando, Florida 32825

Encore Medical Research of Weston LLC
Weston, Florida 33331

Conquest Research - Winter Park
Winter Park, Florida 32789

Alliance For Multispecialty Research - Oak Brook
Oak Brook, Illinois 60523

Alliance for Multispecialty Research, LLC - Park Ridge
Park Ridge, Illinois 66068

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

Indiana Medical Research Institute
Merrillville, Indiana 46410

Iowa Diabetes Research
West Des Moines, Iowa 50266

Alliance for Multispecialty Research Newton
Newton, Kansas 67114

Alliance for Multispecialty Research LLC
Wichita, Kansas 67207

Advanced Internal Medicine
Paducah, Kentucky 42001

Ima Clinical Research- Monroe
Monroe, Louisiana 71201

Annapolis Internal Medicine, LLC
Annapolis, Maryland 21401

Brigham and Womens Hospital
Boston, Massachusetts 02115

International Diabetes Center - HealthPartners Institute
Minneapolis, Minnesota 55416

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

Palm Research Center Inc
Las Vegas, Nevada 89128

Vector Clinical Trials
Sparks, Nevada 89436

Premier Research
Trenton, New Jersey 08611

Albany Medical College
Albany, New York 12203

Asheville Clinical Research
Asheville, North Carolina 28803

Physicians East
Greenville, North Carolina 27834

Carteret Medical Group
Morehead City, North Carolina 28557

West Clinical Research
Morehead City, North Carolina 28557

Velocity Clinical Research - Cincinnati
Blue Ash, Ohio 45242

Velocity Clinical Research - Springdale
Cincinnati, Ohio 45246

Velocity Clinical Research - Providence
East Greenwich, Rhode Island 02818

Medical Care LLC
Elizabethton, Tennessee 37643

Elligo Clinical Research Center
Austin, Texas 78701

Osvaldo A Brusco MD PA
Corpus Christi, Texas 78414

Cedar Health Research, LLC
Dallas, Texas 75251

Soma Clinical Trials, LLC
Denison, Texas 75020

Cedar Health Research, LLC
Euless, Texas 76040

Juno Research LLC
Houston, Texas 77040

Juno Research LLC
Houston, Texas 77054

Tekton Research
McKinney, Texas 75069

Northeast Clinical Research of San Antonio LLC
San Antonio, Texas 78233

Alliance for Multispecialty Research - Layton
Layton, Utah 84041

Manassas Clinical Research Center Inc
Manassas, Virginia 20110

Ima Clinical Research - West Virginia
Morgantown, West Virginia 26505

Latin Clinical Trial Center
San Juan, Puerto Rico 00909

More Details

NCT ID
NCT06858878
Status
Recruiting
Sponsor
Amgen

Study Contact

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

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ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center