ACTIVE_NOT_RECRUITING

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

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Conditions

Type 2 Diabetes Mellitus (T2DM), Obesity, OverweightType 2 Diabetes MellitusT2DMObesityOverweightMaridebart CafraglutideAMG 133MariTideChronic Weight Management

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2)

Quick Facts

Study Start:2025-03-17
Study Completion:2027-04-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06858878

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age ≥ 18 years.
  2. * Body mass index ≥ 27 kg/m\^2.
  3. * History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
  4. * Diagnosis of T2DM.
  1. * Type 1 diabetes mellitus.
  2. * Self-reported change in body weight \> 5 kg within 90 days before screening.
  3. * Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment.
  4. * Obesity induced by other endocrinologic disorders.
  5. * Family (first-degree relative\[s\]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.
  6. * History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
  7. * History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
  8. * Lifetime history of suicide attempt.

Contacts and Locations

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

Alliance for Multispecialty Research Mobile
Mobile, Alabama, 36608
United States
Gilbert Center for Family Medicine
Gilbert, Arizona, 85296
United States
Desert Clinical Research
Mesa, Arizona, 85213
United States
Avacare Foothills Research Center
Phoenix, Arizona, 85044
United States
San Fernando Valley Health Institute
Canoga Park, California, 91304
United States
Core Healthcare Group
Cerritos, California, 90703
United States
Velocity Clinical Research Chula Vista
Chula Vista, California, 91911
United States
Headlands Research California
Escondido, California, 92025
United States
Paradigm Clinical Research
Modesto, California, 95355
United States
Flourish Research
Northridge, California, 91325
United States
University of California Irvine
Orange, California, 92868
United States
Empire Clinical Research
Pomona, California, 91767
United States
Infinity Clinical Trials
San Diego, California, 92108
United States
Greenwich Clinical Trials
Riverside, Connecticut, 06878
United States
Indago Research and Health Center
Hialeah, Florida, 33012
United States
Optimus U Corporation
Miami, Florida, 33135
United States
New Horizon Research Center
Miami, Florida, 33165
United States
San Marcus Research Clinic Inc
Miami Lakes, Florida, 33014
United States
Florida Institute for Clinical Research
Orlando, Florida, 32825
United States
Encore Medical Research of Weston LLC
Weston, Florida, 33331
United States
Conquest Research - Winter Park
Winter Park, Florida, 32789
United States
Alliance For Multispecialty Research - Oak Brook
Oak Brook, Illinois, 60523
United States
Alliance for Multispecialty Research, LLC - Park Ridge
Park Ridge, Illinois, 66068
United States
Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie
Skokie, Illinois, 60077
United States
Indiana Medical Research Institute
Merrillville, Indiana, 46410
United States
Iowa Diabetes Research
West Des Moines, Iowa, 50266
United States
Alliance for Multispecialty Research Newton
Newton, Kansas, 67114
United States
Alliance for Multispecialty Research LLC
Wichita, Kansas, 67207
United States
Advanced Internal Medicine
Paducah, Kentucky, 42001
United States
Ima Clinical Research- Monroe
Monroe, Louisiana, 71201
United States
Annapolis Internal Medicine, LLC
Annapolis, Maryland, 21401
United States
Brigham and Womens Hospital
Boston, Massachusetts, 02115
United States
International Diabetes Center - HealthPartners Institute
Minneapolis, Minnesota, 55416
United States
Alliance for Multispecialty Research - Kansas City
Kansas City, Missouri, 64114
United States
Palm Research Center Inc
Las Vegas, Nevada, 89128
United States
Vector Clinical Trials
Sparks, Nevada, 89436
United States
Premier Research
Trenton, New Jersey, 08611
United States
Albany Medical College
Albany, New York, 12203
United States
Asheville Clinical Research
Asheville, North Carolina, 28803
United States
Physicians East
Greenville, North Carolina, 27834
United States
Carteret Medical Group
Morehead City, North Carolina, 28557
United States
West Clinical Research
Morehead City, North Carolina, 28557
United States
Velocity Clinical Research - Cincinnati
Blue Ash, Ohio, 45242
United States
Velocity Clinical Research - Springdale
Cincinnati, Ohio, 45246
United States
Velocity Clinical Research - Providence
East Greenwich, Rhode Island, 02818
United States
Medical Care LLC
Elizabethton, Tennessee, 37643
United States
Elligo Clinical Research Center
Austin, Texas, 78701
United States
Osvaldo A Brusco MD PA
Corpus Christi, Texas, 78414
United States
Cedar Health Research, LLC
Dallas, Texas, 75251
United States
Soma Clinical Trials, LLC
Denison, Texas, 75020
United States
Cedar Health Research, LLC
Euless, Texas, 76040
United States
Juno Research LLC
Houston, Texas, 77040
United States
Juno Research LLC
Houston, Texas, 77054
United States
Tekton Research
McKinney, Texas, 75069
United States
Northeast Clinical Research of San Antonio LLC
San Antonio, Texas, 78233
United States
Alliance for Multispecialty Research - Layton
Layton, Utah, 84041
United States
Manassas Clinical Research Center Inc
Manassas, Virginia, 20110
United States
VA Puget Sound Healthcare System
Seattle, Washington, 98108
United States
Ima Clinical Research - West Virginia
Morgantown, West Virginia, 26505
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-17
Study Completion Date2027-04-25

Study Record Updates

Study Start Date2025-03-17
Study Completion Date2027-04-25

Terms related to this study

Keywords Provided by Researchers

  • Type 2 Diabetes Mellitus
  • T2DM
  • Obesity
  • Overweight
  • Maridebart Cafraglutide
  • AMG 133
  • MariTide
  • Chronic Weight Management

Additional Relevant MeSH Terms

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