NCT07866066 · Amgen
Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes
(MARITIME-T2D-3)
What this study is about
The main objective of this trial is to evaluate whether maridebart cafraglutide is non-inferior to semaglutide in improving glycemic control in participants with type 2 diabetes (T2D) who are receiving metformin treatment, with or without a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.
View original scientific description
The main objective of this trial is to evaluate whether maridebart cafraglutide is non-inferior to semaglutide in improving glycemic control in participants with type 2 diabetes (T2D) who are receiving metformin treatment, with or without a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.
Interventions
DRUG
Maridebart cafraglutide
Administered subcutaneously.
DRUG
Semaglutide
Administered subcutaneously.
Primary outcome measures
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 68 [Non-inferiority]
Time frame: Baseline to Week 68
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- HbA1c of ≥ 7.5% (58.0 millimoles per mole (mmol/mol)) and ≤ 10.5% (91.0 mmol/mol) at screening.
- Treatment of Type 2 diabetes (T2D) with metformin (≥ 1500 milligrams per day (mg/day), or maximum tolerated dose as per investigator judgment) with or without an sodium-glucose cotransporter-2 (SGLT-2) inhibitor on a stable total daily dose for at least 90 days prior to randomization.
- Body mass index (BMI) ≥ 25 kilograms per meter squared (kg/m\^2) at screening.
Exclusion criteria
- Type 1 diabetes mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes mellitus except T2D or past history of gestational diabetes.
- Participants who are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
- Participants who have a diagnosis of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy.
- One or more episode of severe hypoglycemia (Level 3 hypoglycemia) within 180 days before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery.
- History of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
- Self-reported change in body weight \> 5% within 90 days before screening. Participants must also agree to not initiate an intensive diet or exercise program during the trial with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment.
- Previous or planned (during the trial) surgical, endoscopic, or device-based treatment for obesity. The following are allowed:
- liposuction and/or abdominoplasty that was performed \> 1 year before screening.
- laparoscopic adjustable gastric banding, intragastric balloon, and/or duodenal-jejunal bypass liner or gastric sleeve if removed \> 1 year before screening.
Where
- San Diego, California
- Miami, Florida
- Miami Lakes, Florida
- Pompano Beach, Florida
- Winter Park, Florida
- Arlington, Virginia
- Redmond, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 5, 2026 · Source of record for eligibility and locations