Amgen Launches Phase III MARITIME-CV Trial of Maridebart Cafraglutide (AMG 133) in Patients with Atherosclerotic Cardiovascular Disease and Overweight or Obesity

Data from the Drug Clinical Trial Registration and Information Disclosure Platform shows that a randomized, double-blind, placebo-controlled Phase III study (MARITIME - CV) evaluating the impact of Maridebart Cafraglutide on cardiovascular outcomes in participants with atherosclerotic cardiovascular disease combined with overweight or obesity, conducted by Amgen Inc./Amgen Biology Technology Consulting (Shanghai) Co., Ltd./Amgen Inc.; Amgen Europe B.V., has been initiated. The clinical trial registration number is CTR20253681, and the initial information disclosure date was September 10, 2025.

The drug formulation is a PFS-packaged injectable solution, with a dosage of 350mg administered once every four weeks via subcutaneous injection. The treatment duration is approximately 59 months (including a 35-month double-blind period and a 24-month open-label period). The primary objective of this trial is to demonstrate that maridebart cafraglutide (on top of standard-of-care) is superior to placebo in reducing cardiovascular (CV) morbidity and mortality (dual primary endpoints).

AMG 133 is a biologic indicated for atherosclerotic cardiovascular disease combined with overweight or obesity. Atherosclerotic cardiovascular disease refers to conditions caused by atherosclerosis leading to vascular stenosis or blockage, with symptoms such as angina and shortness of breath. Overweight and obesity refer to excessive body fat, with a BMI ≥27 kg/m². Diagnosis relies on examinations and indicator assessments.

The primary endpoint of this trial includes the time to the first occurrence of the composite endpoint (CV death, myocardial infarction [MI], or ischemic stroke; all-cause death, MI, ischemic stroke, coronary revascularization, or heart failure [HF] event); secondary endpoints include the time to the first occurrence of the composite endpoint (CV death, MI, ischemic stroke, or HF event; CV death, MI, ischemic stroke, or coronary revascularization), time to the first occurrence of MI, time to the first occurrence of ischemic stroke, and time to CV death.

Currently, the trial status is ongoing (not yet recruiting), with a target enrollment of 538 participants in China and 12,800 participants internationally. So far, 30 participants have been enrolled internationally.

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Editor: Xiaolang Express