BIOLOGICAL
Maridebart Cafraglutide
Participants will receive maridebart cafraglutide by subcutaneous (SC) injection.
Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 2
Enrollment
592
Locations
78
Results
Not posted
Publications
1
Study summary
What the protocol is testing.
The study aims to compare and assess the dose response of 3 selected doses of maridebart cafraglutide compared with placebo, on inducing and maintaining weight loss from baseline at Week 52 in participants with overweight or obesity without diabetes mellitus (Cohort A) and in participants with overweight or obesity with Type 2 diabetes mellitus (Cohort B).
Interventions
Treatment arms and agents.
DRUG
Placebo
Participants will receive placebo by SC injection.
Timeline
From registration to results.
First posted
Jan 3, 2023
Study start
Jan 18, 2023
Primary completion
Oct 8, 2024
Study completion
Dec 16, 2025
Results posted
Not reported
Registry updated
Jan 20, 2026
Outcomes
What the study measures.
Primary outcomes
Percent Change From Baseline to Week 52 in Body Weight
Time frame · Baseline and Week 52
Secondary outcomes
Percentage of Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 52
Time frame · Baseline and Week 52
Percentage of Participants Achieving ≥ 10% Reduction in Body Weight From Baseline at Week 52
Time frame · Baseline and Week 52
Achievement of ≥ 15% Reduction in Body Weight From Baseline at Week 52
Time frame · Baseline and Week 52
Achievement of ≥ 20% Reduction in Body Weight From Baseline at Week 52
Time frame · Baseline and Week 52
Change from Baseline to Week 52 in Hemoglobin A1c (HbA1c)
Time frame · Baseline and Week 52
Change from Baseline to Week 52 in Fasting Serum Insulin
Time frame · Baseline and Week 52
Change from Baseline to Week 52 in Fasting Plasma Glucose
Time frame · Baseline and Week 52
Change from Baseline to Week 52 in Homeostasis Model Assessment for Insulin Resistance (HOMA2-IR)
Time frame · Baseline and Week 52
Change from Baseline to Week 52 in Homeostasis Model Assessment for Steady State Beta Cell Function (HOMA2-%B)
Time frame · Baseline and Week 52
Maximum Observed Plasma Concentration (Cmax) of maridebart cafraglutide
Time frame · Up to Week 64
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 99 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥18 years at the time of signing informed consent. * BMI ≥30 kg/m\^2, or ≥27 kg/m\^2 and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease. * For participants in cohort B only, HbA1c ≥ 7% and ≤ 10% (53 to 86 mmol/mol) at screening with an established diagnosis of type 2 diabetes mellitus for ≥ 180 days prior to screening and either treated with diet and exercise alone or on stable (at least 90 days prior to screening) treatment with metformin, a sulfonylurea, or a sodium-glucose cotransporter 2 (SGLT2) inhibitor as monotherapy or combination therapy, per approved local label. * History of at least one unsuccessful dietary effort to lose body weight. Exclusion Criteria: * Change in body weight greater than 5 kg within 3 months prior to screening. * Obesity induced by other endocrinologic disorders. * History of pancreatitis. * Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2). * History of major depressive disorder within the last 2 years. * Any lifetime history of other major psychiatric disorder or suicide attempt.
Study locations
78 registered sites.
Australia · Canada · Czechia · Germany · Hong Kong · Hungary · Japan · Poland · South Korea · Spain · Taiwan · United States. Showing up to 24 locations stored in the fast local snapshot.
Alliance for Multispecialty Research Mobile
Mobile, Alabama, United States
Foothills Research Center
Phoenix, Arizona, United States
HonorHealth
Scottsdale, Arizona, United States
Ark Clinical Research- Long Beach
Long Beach, California, United States
Ark Clinical Research- Tustin
Tustin, California, United States
Orange County Research Center
Tustin, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Alliance for Multispecialty Research Miami
Coral Gables, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
East-West Medical Research
Honolulu, Hawaii, United States
University of Chicago
Chicago, Illinois, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Alliance for Multispecialty Research Newton
Newton, Kansas, United States
Louisville Metabolic and Atherosclerosis Research Center
Louisville, Kentucky, United States
Tandem Clinical Research - Marrero
Marrero, Louisiana, United States
StudyMetrix Research
City of Saint Peters, Missouri, United States
Alliance for Multispecialty Research Kansas City
Kansas City, Missouri, United States
State University of New York Upstate Medical University
Syracuse, New York, United States
Lucas Research
Morehead City, North Carolina, United States
Research Innovations LLC dba Internal Medicine Care Inc
Beavercreek, Ohio, United States
The Christ Hospital
Cincinnati, Ohio, United States
Alliance for Multispecialty Research Norman
Norman, Oklahoma, United States
Medical Care LLC
Elizabethton, Tennessee, United States
PanAmerican Clinical Research LLC
Brownsville, Texas, United States
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.
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