DRUG
Maridebart Cafraglutide
Maridebart cafraglutide will be administered SC.
Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight
Status
Active, not recruiting
Phase
Phase 3
Enrollment
3,853
Locations
243
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 administered SC.
Timeline
From registration to results.
First posted
Mar 5, 2025
Study start
Mar 12, 2025
Primary completion
Jan 21, 2027
Study completion
Apr 16, 2027
Results posted
Not reported
Registry updated
Oct 20, 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 · Week 72
Participant achieving ≥ 10% reduction in body weight from baseline at week 72
Time frame · Week 72
Participant achieving ≥ 15% reduction in body weight from baseline at week 72
Time frame · Week 72
Participant achieving ≥ 20% reduction in body weight from baseline at week 72
Time frame · 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 Glucose at Week 72
Time frame · Baseline and 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
The IWQOL-Lite-CT is a 20-item questionnaire designed to assess the impact of weight on quality of life in clinical trials. Items are scored on a 5-point Likert scale, with raw scores transformed to a 0-100 scale, where higher scores indicate better quality of life and less weight-related impact.
Change From Baseline in Body Weight 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 ≥ 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). * History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise. Exclusion Criteria: * Type 1 or Typ2 diabetes mellitus. * Obesity induced by other endocrinologic disorders. * Self-reported change in body weight \> 5 kg within 90 days before screening. * 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
243 registered sites.
Argentina · Australia · Belgium · Canada · Czechia · Denmark · Finland · Germany · Italy · Japan · Poland · Puerto Rico · South Korea · Spain · Switzerland · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Pinnacle Research Group LLC
Anniston, Alabama, United States
Alliance For Multispecialty Research - Daphne
Daphne, Alabama, United States
Alliance for Multispecialty Research Mobile
Mobile, Alabama, United States
Avacare Foothills Research Center
Phoenix, Arizona, United States
Ark Clinical Research- Tustin
Fountain Valley, California, United States
Long Beach Clinical Trials Services Inc
Long Beach, California, United States
Ark Clinical Research- Long Beach
Long Beach, California, United States
Catalina Research Institute
Montclair, California, United States
Artemis Institute for Clinical Research
Riverside, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Apex Clinical Research
San Diego, California, United States
Southern California Clinical Research
Santa Ana, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Yale School of Medicine
New Haven, Connecticut, United States
Chase Medical Research LLC
Waterbury, Connecticut, United States
Indago Research and Health Center
Hialeah, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Clinical Neuroscience Solutions - Jacksonville
Jacksonville, Florida, United States
South Florida Wellness and Clinical Research Institute
Margate, Florida, United States
Optimus U Corporation
Miami, Florida, United States
Research Institute of South Florida
Miami, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Clinical Neuroscience Solutions - Orlando
Orlando, Florida, United States
Combined Research Orlando Phase I IV
Orlando, Florida, 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.