MARITIME-CV

The MARITIME-CV Study is a Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants with Atherosclerotic Cardiovascular Disease and Overweight or Obesity

This study is being done to learn if maridebart cafraglutide (MariTide) can reduce the risk of cardiovascular events such as heart attacks and strokes in people with atherosclerotic cardiovascular disease (ASCVD) and obesity or overweight. ASCVD is a condition in which blood vessels become narrowed or blocked due to the buildup of substances like cholesterol, and obesity is excessive body fat that increases the risk of various health problems.

Time Commitment:
The screening period lasts up to 4 weeks and includes an initial screening visit and
an eye exam. If you are enrolled into the treatment portion of the study, you will come to the research clinic for in-person study visits for up to 88 weeks.

Visits include:
Signing a consent and having an eye exam (at screening), ECG, blood pressure, physical exam and
measurements, blood and urine samples, completing questionnaires, and receiving study drug.

Risks/Benefits:
You may lose weight.
If you have diabetes: You may not need as many diabetes medications and your diabetes may be better controlled.
While you may not benefit directly from participating in this research study, the information we obtain may help us better understand how to treat atherosclerotic cardiovascular disease (ASCVD) in patients who are obese or overweight.

Participant Eligibility

To qualify you must have:

1. Body mass index ≥ 27 kg/m2 at screening
2. Be 45 years of age or older
3. Have a history of ASCVD:
~Prior myocardial infarction (MI)
~or Prior ischemic stroke (may include ischemic stroke with hemorrhagic transformation)
~or Symptomatic PAD, as evidenced by :
*intermittent claudication
*peripheral arterial revascularization procedure
*or amputation due to atherosclerotic disease

You will not qualify if you have:

1. History of certain cardiovascular events 60 days before screening with the study (call for
screening!)
2. Type 1 diabetes or diabetes that is not type 2
3. Significant eye disease related to your diabetes (diabetic retinopathy)
4. One or more episodes of severe low blood glucose (hypoglycemia) within the past 6 months
5. HbA1c > 10.0%

Contact

Karen Atkinson, MSN, RN
Alexandra Kozedub, ARNP
Shania Remal, Research Coordinator
(206) 768-5338