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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 ≥ 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 4076598, Alabama 4829764 36608

Gilbert Center for Family Medicine
Gilbert 5295903, Arizona 5551752 85296

Desert Clinical Research
Mesa 5304391, Arizona 5551752 85213

Avacare Foothills Research Center
Phoenix 5308655, Arizona 5551752 85044

San Fernando Valley Health Institute
Canoga Park 5333913, California 5332921 91304

Core Healthcare Group
Cerritos 5335663, California 5332921 90703

Velocity Clinical Research Chula Vista
Chula Vista 5336899, California 5332921 91911

Headlands Research California
Escondido 5346827, California 5332921 92025

Paradigm Clinical Research
Modesto 5373900, California 5332921 95355

Flourish Research
Northridge 5377985, California 5332921 91325

University of California Irvine
Orange 5379513, California 5332921 92868

Empire Clinical Research
Pomona 5384170, California 5332921 91767

Infinity Clinical Trials
San Diego 5391811, California 5332921 92108

Greenwich Clinical Trials
Riverside 4841527, Connecticut 4831725 06878

Indago Research and Health Center
Hialeah 4158476, Florida 4155751 33012

Optimus U Corporation
Miami 4164138, Florida 4155751 33135

New Horizon Research Center
Miami 4164138, Florida 4155751 33165

San Marcus Research Clinic Inc
Miami Lakes 4164186, Florida 4155751 33014

Florida Institute for Clinical Research
Orlando 4167147, Florida 4155751 32825

Encore Medical Research of Weston LLC
Weston 4178003, Florida 4155751 33331

Conquest Research - Winter Park
Winter Park 4178560, Florida 4155751 32789

Alliance For Multispecialty Research - Oak Brook
Oak Brook 4904277, Illinois 4896861 60523

Alliance for Multispecialty Research, LLC - Park Ridge
Park Ridge 4905367, Illinois 4896861 66068

Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie
Skokie 4911600, Illinois 4896861 60077

Indiana Medical Research Institute
Merrillville 4923482, Indiana 4921868 46410

Iowa Diabetes Research
West Des Moines 4881346, Iowa 4862182 50266

Alliance for Multispecialty Research Newton
Newton 4276248, Kansas 4273857 67114

Alliance for Multispecialty Research LLC
Wichita 4281730, Kansas 4273857 67207

Advanced Internal Medicine
Paducah 4048662, Kentucky 6254925 42001

Ima Clinical Research- Monroe
Monroe 4333669, Louisiana 4331987 71201

Annapolis Internal Medicine, LLC
Annapolis 4347242, Maryland 4361885 21401

Brigham and Womens Hospital
Boston 4930956, Massachusetts 6254926 02115

International Diabetes Center - HealthPartners Institute
Minneapolis 5037649, Minnesota 5037779 55416

Alliance for Multispecialty Research - Kansas City
Kansas City 4393217, Missouri 4398678 64114

Palm Research Center Inc
Las Vegas 5506956, Nevada 5509151 89128

Vector Clinical Trials
Sparks 5512862, Nevada 5509151 89436

Premier Research
Trenton 5105496, New Jersey 5101760 08611

Asheville Clinical Research
Asheville 4453066, North Carolina 4482348 28803

Physicians East
Greenville 4469160, North Carolina 4482348 27834

Carteret Medical Group
Morehead City 4480153, North Carolina 4482348 28557

West Clinical Research
Morehead City 4480153, North Carolina 4482348 28557

Velocity Clinical Research - Cincinnati
Blue Ash 4506754, Ohio 5165418 45242

Velocity Clinical Research - Springdale
Cincinnati 4508722, Ohio 5165418 45246

Velocity Clinical Research - Providence
East Greenwich 5221875, Rhode Island 5224323 02818

Medical Care LLC
Elizabethton 4620634, Tennessee 4662168 37643

Elligo Clinical Research Center
Austin 4671654, Texas 4736286 78701

Osvaldo A Brusco MD PA
Corpus Christi 4683416, Texas 4736286 78414

Cedar Health Research, LLC
Dallas 4684888, Texas 4736286 75251

Soma Clinical Trials, LLC
Denison 4685892, Texas 4736286 75020

Cedar Health Research, LLC
Euless 4689550, Texas 4736286 76040

Juno Research LLC
Houston 4699066, Texas 4736286 77040

Juno Research LLC
Houston 4699066, Texas 4736286 77054

Tekton Research
McKinney 4710178, Texas 4736286 75069

Northeast Clinical Research of San Antonio LLC
San Antonio 4726206, Texas 4736286 78233

Alliance for Multispecialty Research - Layton
Layton 5777107, Utah 5549030 84041

Manassas Clinical Research Center Inc
Manassas 4771401, Virginia 6254928 20110

VA Puget Sound Healthcare System
Seattle 5809844, Washington 5815135 98108

Ima Clinical Research - West Virginia
Morgantown 4815352, West Virginia 4826850 26505

Latin Clinical Trial Center
San Juan 4568127, Puerto Rico 00909

More Details

NCT ID
NCT06858878
Status
Recruiting
Sponsor
Amgen

Study Contact

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

Notice

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