Testing maridebart cafraglutide for weight loss in adults with type 2 diabetes and obesity
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)
This study tests whether a new weight loss medication called maridebart cafraglutide can help adults with type 2 diabetes and obesity lose weight better than a placebo.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 999 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Amgen Industry-sponsored |
| Locations | 83 sites (Mobile, Alabama and 82 other locations) |
| Trial ID | NCT06858878 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of maridebart cafraglutide in adults with type 2 diabetes mellitus who are overweight or obese. Participants will receive either the medication or a placebo to assess the change in body weight over the course of the study. The trial aims to demonstrate that maridebart cafraglutide is more effective than placebo in promoting weight loss among this population. The study is designed for individuals who have previously struggled with weight loss through diet and exercise.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a body mass index of 27 kg/m² or higher and a diagnosis of type 2 diabetes.
Not a fit: Patients with type 1 diabetes, significant recent weight changes, or certain serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new option for weight management in patients with type 2 diabetes, potentially improving their overall health and diabetes control.
How similar studies have performed: Other studies have shown promising results with similar weight loss medications in patients with type 2 diabetes, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Mobile, Alabama and 82 other locations
- Alliance for Multispecialty Research Mobile — Mobile, Alabama, United States (Recruiting)
- Gilbert Center for Family Medicine — Gilbert, Arizona, United States (Recruiting)
- Desert Clinical Research — Mesa, Arizona, United States (Recruiting)
- Avacare Foothills Research Center — Phoenix, Arizona, United States (Recruiting)
- San Fernando Valley Health Institute — Canoga Park, California, United States (Recruiting)
- Core Healthcare Group — Cerritos, California, United States (Recruiting)
- Velocity Clinical Research Chula Vista — Chula Vista, California, United States (Recruiting)
- Headlands Research California — Escondido, California, United States (Recruiting)
- Paradigm Clinical Research — Modesto, California, United States (Recruiting)
- Flourish Research — Northridge, California, United States (Recruiting)
- University of California Irvine — Orange, California, United States (Recruiting)
- Empire Clinical Research — Pomona, California, United States (Recruiting)
- Infinity Clinical Trials — San Diego, California, United States (Recruiting)
- Greenwich Clinical Trials — Riverside, Connecticut, United States (Recruiting)
- Indago Research and Health Center — Hialeah, Florida, United States (Recruiting)
- San Marcus Research Clinic Inc — Miami Lakes, Florida, United States (Recruiting)
- Optimus U Corporation — Miami, Florida, United States (Recruiting)
- New Horizon Research Center — Miami, Florida, United States (Recruiting)
- Florida Institute for Clinical Research — Orlando, Florida, United States (Recruiting)
- Encore Medical Research of Weston LLC — Weston, Florida, United States (Recruiting)
- Conquest Research - Winter Park — Winter Park, Florida, United States (Recruiting)
- Alliance For Multispecialty Research - Oak Brook — Oak Brook, Illinois, United States (Recruiting)
- Alliance for Multispecialty Research, LLC - Park Ridge — Park Ridge, Illinois, United States (Recruiting)
- Endeavor Health Medical Group - Endocrinology and Diabetes- Skokie — Skokie, Illinois, United States (Recruiting)
- Indiana Medical Research Institute — Merrillville, Indiana, United States (Recruiting)
- Iowa Diabetes Research — West Des Moines, Iowa, United States (Recruiting)
- Alliance for Multispecialty Research Newton — Newton, Kansas, United States (Recruiting)
- Alliance for Multispecialty Research LLC — Wichita, Kansas, United States (Recruiting)
- Advanced Internal Medicine — Paducah, Kentucky, United States (Recruiting)
- Ima Clinical Research- Monroe — Monroe, Louisiana, United States (Recruiting)
- Annapolis Internal Medicine, LLC — Annapolis, Maryland, United States (Recruiting)
- Brigham and Womens Hospital — Boston, Massachusetts, United States (Recruiting)
- International Diabetes Center - HealthPartners Institute — Minneapolis, Minnesota, United States (Recruiting)
- Alliance for Multispecialty Research - Kansas City — Kansas City, Missouri, United States (Recruiting)
- Palm Research Center Inc — Las Vegas, Nevada, United States (Recruiting)
- Vector Clinical Trials — Sparks, Nevada, United States (Recruiting)
- Premier Research — Trenton, New Jersey, United States (Recruiting)
- Albany Medical College — Albany, New York, United States (Recruiting)
- Asheville Clinical Research — Asheville, North Carolina, United States (Recruiting)
- Physicians East — Greenville, North Carolina, United States (Recruiting)
- Carteret Medical Group — Morehead City, North Carolina, United States (Recruiting)
- West Clinical Research — Morehead City, North Carolina, United States (Recruiting)
- Velocity Clinical Research - Cincinnati — Blue Ash, Ohio, United States (Recruiting)
- Velocity Clinical Research - Springdale — Cincinnati, Ohio, United States (Recruiting)
- Velocity Clinical Research - Providence — East Greenwich, Rhode Island, United States (Recruiting)
- Medical Care LLC — Elizabethton, Tennessee, United States (Recruiting)
- Elligo Clinical Research Center — Austin, Texas, United States (Recruiting)
- Osvaldo A Brusco MD PA — Corpus Christi, Texas, United States (Recruiting)
- Cedar Health Research, LLC — Dallas, Texas, United States (Recruiting)
- Soma Clinical Trials, LLC — Denison, Texas, United States (Recruiting)
+33 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Amgen Call Center
- Email: medinfo@amgen.com
- Phone: 866-572-6436
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.