ACTIVE_NOT_RECRUITING

Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

Talk to us

Conditions

ObesityOverweightBMIBody weightMaridebart cafraglutideChronic weight managementMariTide

Quick Navigation

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 Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

Quick Facts

Study Start:2025-03-12
Study Completion:2027-04-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06858839

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 ≥ 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).
  3. * History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
  1. * Type 1 or Typ2 diabetes mellitus.
  2. * Obesity induced by other endocrinologic disorders.
  3. * Self-reported change in body weight \> 5 kg within 90 days before screening.
  4. * Family (first-degree relative\[s\]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.
  5. * History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
  6. * History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
  7. * Lifetime history of suicide attempt.

Contacts and Locations

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

Pinnacle Research Group LLC
Anniston, Alabama, 36207
United States
Alliance For Multispecialty Research - Daphne
Daphne, Alabama, 36526
United States
Alliance for Multispecialty Research Mobile
Mobile, Alabama, 36608
United States
Avacare Foothills Research Center
Phoenix, Arizona, 85044
United States
Ark Clinical Research- Tustin
Fountain Valley, California, 92708
United States
Long Beach Clinical Trials Services Inc
Long Beach, California, 90806
United States
Ark Clinical Research- Long Beach
Long Beach, California, 90815
United States
Catalina Research Institute
Montclair, California, 91763
United States
Artemis Institute for Clinical Research
Riverside, California, 92503
United States
Artemis Institute for Clinical Research
San Diego, California, 92103
United States
Apex Clinical Research
San Diego, California, 92120
United States
Southern California Clinical Research
Santa Ana, California, 92701
United States
Diablo Clinical Research
Walnut Creek, California, 94598
United States
Yale School of Medicine
New Haven, Connecticut, 06520
United States
Chase Medical Research LLC
Waterbury, Connecticut, 06708
United States
Indago Research and Health Center
Hialeah, Florida, 33012
United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
United States
Clinical Neuroscience Solutions - Jacksonville
Jacksonville, Florida, 32256
United States
South Florida Wellness and Clinical Research Institute
Margate, Florida, 33063
United States
Optimus U Corporation
Miami, Florida, 33135
United States
Research Institute of South Florida
Miami, Florida, 33173
United States
Renstar Medical Research
Ocala, Florida, 34470
United States
Clinical Neuroscience Solutions - Orlando
Orlando, Florida, 32801
United States
Combined Research Orlando Phase I IV
Orlando, Florida, 32807
United States
Florida Institute for Clinical Research
Orlando, Florida, 32825
United States
Encore Medical Research of Weston LLC
Weston, Florida, 33331
United States
Center for Advanced Research and Education
Gainesville, Georgia, 30501
United States
Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group
Union City, Georgia, 30291
United States
East-West Medical Research
Honolulu, Hawaii, 96814
United States
Solaris Clinical Research
Meridian, Idaho, 83646
United States
Flourish Research - Great Lakes Clinical Trials
Chicago, Illinois, 60640
United States
Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie
Skokie, Illinois, 60077
United States
Evanston Premier Healthcare Research LLC
Skokie, Illinois, 60077
United States
Alliance for Multispecialty Research Newton
Newton, Kansas, 67114
United States
Louisville Metabolic and Atherosclerosis Research Center
Louisville, Kentucky, 40213
United States
Velocity Clinical Research - Baton Rouge
Baton Rouge, Louisiana, 70809
United States
Tandem Clinical Research - Marrero
Marrero, Louisiana, 70072
United States
Headlands Research - Detroit
Southfield, Michigan, 48034
United States
Prime Health and Wellness Sky Clinical Research Network Group
Fayette, Mississippi, 39069
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
Las Vegas, Nevada, 89128
United States
Rochester Clinical Research
Rochester, New York, 14609
United States
Velocity Clinical Research- Binghamton
Vestal, New York, 13850
United States
Accellacare of Hickory
Hickory, North Carolina, 28601
United States
Carolina Research Center Inc
Shelby, North Carolina, 28150
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
United States
Clinical Trial Investigator Clinical Research Center
Cincinnati, Ohio, 45212
United States
Velocity Clinical Research - Cincinnati
Cincinnati, Ohio, 45219
United States
Alliance for Multispecialty Research - Norman
Norman, Oklahoma, 73069
United States
Capital Area Research LLC
Newport, Pennsylvania, 17074
United States
Velocity Clinical Research - Providence
East Greenwich, Rhode Island, 02818
United States
Tribe Clinical Research LLC Dba Mountain View Clinical Research
Greenville, South Carolina, 29607
United States
New Phase Research and Development
Knoxville, Tennessee, 37909
United States
Accellacare US Inc., d/b/a Accellacare of Knoxville
Knoxville, Tennessee, 37938
United States
Elligo Clinical Research Center
Austin, Texas, 78704
United States
Cedar Health Research, LLC
Dallas, Texas, 75251
United States
Epic Medical Research - Texas
DeSoto, Texas, 75115
United States
Great Lakes Research Institute El Paso Research
El Paso, Texas, 79936
United States
Cedar Health Research, LLC
Euless, Texas, 76040
United States
Juno Research LLC
Houston, Texas, 77040
United States
Biopharma Informatic, LLC
Houston, Texas, 77043
United States
Juno Research LLC
Houston, Texas, 77054
United States
Southern Endocrinology Associates PA
Mesquite, Texas, 75149
United States
Great Lakes Research Institute - McAllen Research
Pharr, Texas, 78557
United States
Clinical Trials of Texas
San Antonio, Texas, 78229
United States
Sugar Lakes Family Practice
Sugar Land, Texas, 77479
United States
Pantheon Clinical Research
Bountiful, Utah, 84010
United States
Alliance for Multispecialty Research Layton Research Center
Layton, Utah, 84041
United States
Chrysalis Clinical Research, LLC
St. George, Utah, 84770
United States
Washington Center for Weight Management and Research, Inc
Arlington, Virginia, 22206
United States
Health Research of Hampton Roads
Newport News, Virginia, 23606
United States
Selma Medical Associates
Winchester, Virginia, 22601
United States
Allegiance Research Specialists
Milwaukee, Wisconsin, 53226
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 Date2025-03-12
Study Completion Date2027-04-27

Study Record Updates

Study Start Date2025-03-12
Study Completion Date2027-04-27

Terms related to this study

Keywords Provided by Researchers

  • Overweight
  • BMI
  • Body weight
  • Maridebart cafraglutide
  • Chronic weight management
  • MariTide

Additional Relevant MeSH Terms

  • Obesity