DRUG
Maridebart cafraglutide
Maridebart cafraglutide will be adminstered SC.
Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
Status
Active, not recruiting
Phase
Phase 3
Enrollment
1,105
Locations
187
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.
Interventions
Treatment arms and agents.
DRUG
Placebo
Placebo will be adminstered SC.
Timeline
From registration to results.
First posted
Mar 5, 2025
Study start
Mar 17, 2025
Primary completion
Jan 21, 2027
Study completion
Apr 16, 2027
Results posted
Not reported
Registry updated
Dec 31, 2025
Outcomes
What the study measures.
Primary outcomes
Percent Change from Baseline in Body Weight at Week 72
Time frame · Baseline and Week 72
Secondary outcomes
Change from Baseline in Waist Circumference at Week 72
Time frame · Baseline and Week 72
Participant achieving ≥ 5% reduction in body weight from baseline at week 72
Time frame · Baseline and Week 72
Participant achieving ≥ 10% reduction in body weight from baseline at week 72
Time frame · Baseline and Week 72
Participant achieving ≥ 15% reduction in body weight from baseline at week 72
Time frame · Baseline and Week 72
Change from Baseline in Systolic Blood Pressure (SBP) at Week 72
Time frame · Baseline and Week 72
Percent Change from Baseline in Fasting Triglycerides at Week 72
Time frame · Baseline and Week 72
Change from Baseline in Fasting Plasma Glucose at Week 72
Time frame · Baseline and Week 72
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72
Time frame · Baseline and Week 72
Participant achieving HbA1c < 7% at week 72
Time frame · Week 72
Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72
Time frame · Baseline and Week 72
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 99 Years
- Sex
- ALL
- 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 locations
187 registered sites.
Argentina · Bulgaria · Canada · Czechia · Germany · Hungary · Italy · Japan · Poland · Puerto Rico · South Korea · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Alliance for Multispecialty Research Mobile
Mobile, Alabama, United States
Gilbert Center for Family Medicine
Gilbert, Arizona, United States
Desert Clinical Research
Mesa, Arizona, United States
Avacare Foothills Research Center
Phoenix, Arizona, United States
San Fernando Valley Health Institute
Canoga Park, California, United States
Core Healthcare Group
Cerritos, California, United States
Velocity Clinical Research Chula Vista
Chula Vista, California, United States
Headlands Research California
Escondido, California, United States
Paradigm Clinical Research
Modesto, California, United States
Flourish Research
Northridge, California, United States
University of California Irvine
Orange, California, United States
Empire Clinical Research
Pomona, California, United States
Infinity Clinical Trials
San Diego, California, United States
Greenwich Clinical Trials
Riverside, Connecticut, United States
Indago Research and Health Center
Hialeah, Florida, United States
Optimus U Corporation
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
San Marcus Research Clinic Inc
Miami Lakes, Florida, United States
Florida Institute for Clinical Research
Orlando, Florida, United States
Encore Medical Research of Weston LLC
Weston, Florida, United States
Conquest Research - Winter Park
Winter Park, Florida, United States
Alliance For Multispecialty Research - Oak Brook
Oak Brook, Illinois, United States
Alliance for Multispecialty Research, LLC - Park Ridge
Park Ridge, Illinois, United States
Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie
Skokie, Illinois, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Maridebart cafraglutide.
NCT IDStudyPhase / statusEnrollmentUpdated
Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
Amgen · Atherosclerotic Cardiovascular Disease · Overweight
Phase 3
Recruiting
12,800
2026-07
Efficacy, Safety and Tolerability of Switching From Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) to Maridebart Cafraglutide in Adults With Obesity or Overweight (MARITIME-SWITCH)
Amgen · Obesity or Overweight
Phase 3
Recruiting
300
2026-07
A Trial to Assess Bioavailability of AMG 133 in Participants With Overweight or Obesity
Amgen · Overweight and Obesity
Phase 1
Completed
154
2026-07
Effect of Maridebart Cafraglutide on How Oral Contraceptives Are Absorbed and Processed in the Body in Postmenopausal Female Participants Living With Overweight or Obesity
Amgen · Overweight · Obesity
Phase 1
Active, not recruiting
49
2026-07
A Trial to Compare the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous Presentations
Amgen · Overweight and Obesity
Phase 1
Completed
349
2026-07
Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)
Amgen · Obesity · Overweight
Phase 3
Not yet recruiting
950
2026-07
Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)
Amgen · Obesity · Overweight
Phase 3
Not yet recruiting
3,200
2026-07
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
Amgen · Heart Failure With Preserved Ejection Fraction · Heart Failure With Mildly Reduced Ejection Fraction
Phase 3
Recruiting
5,056
2026-07
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.