MARITIME-CV

Summary of a new Cardiovascular Outcomes Trial (CVOT) called “MARITIME-CV”:

This study is being done to learn more about maridebart cafraglutide (MariTide) in people with atherosclerotic cardiovascular disease (ASCVD) and obesity or overweight in addition to their routine medical care. 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.

This trial is being performed in conjunction with the Thrombolysis in Myocardial Infarction (TIMI) Study Group, an academic research organization based at Brigham and Women’s Hospital and Harvard Medical School.

Study Drug: Maridebart cafraglutide (also known as MariTide) is an antibody/peptide conjugate with a long half-life enabling dosing once a month via SQ injection. Two GLP-1 agonist peptides are linked to a human monoclonal GIP receptor antibody.

Study Design: This is a randomized, double blinded, placebo controlled trial with 2 parts that will be performed one after the other:

Part 1 of the study will check if MariTide is safe and better than the placebo (inactive substance) in reducing the risk of cardiovascular events like heart attack (loss of heart function due to disrupted blood flow), stroke (loss of brain function due to disrupted blood flow), coronary revascularization (procedure to improve blood flow to the heart), and heart failure (when the heart cannot pump blood properly), and whether it helps people live longer, and causes any side effects.

Participants will be enrolled into Part 1 over a period of approximately 20 months. The full length of the study depends on how quickly people enter the study, and how many of them have the events that are being followed in the study. Part 1 is expected to end around 15 months after the last participant is enrolled. You could be in the study for up to 3.5 years, but it could be shorter or longer depending on when you are enrolled.

Part 2 will continue to check if MariTide is safe and effective in reducing cardiovascular events like heart attack, stroke, coronary revascularization, and heart failure, and if it helps people live longer, and whether it causes any side effects. All participants in MariTide and placebo groups who are still active in Part 1 when it ends will be given the opportunity to take part in Part 2 and, if they agree to continue, will receive MariTide for up to 2 years. All participants in Part 2 will receive active study treatment with MariTide – there will be no placebo in this part of the study.

Participant Eligibility

Key inclusion criteria include:

> 45 years of age
BMI > 27 kg/m2
Prior MI, ischemic stroke or symptomatic PAD with or without type 2 diabetes

Key exclusion criteria include:

Diabetes: Other forms of diabetes that are not type 2, A1c > 10%, DKA/HHS within 12 months or severe hypoglycemia within 6 months
Medications: treatment within 90 days GLP-1, GIP, amylin, MDI insulin or insulin pump, weight loss meds or meds that cause weight gain
Medical history: recent CVD event (<60days), CHF class 4, h/o PDR, CME or NPDR requiring treatment, h/o pancreatitis, EGFR < 20, pancreatitis, MEN1, bariatric surgery, major depression (2 years) or self-injury (5 years), malignancy (5 years), organ transplant, calcitonin > 50.

Contact

Karen Atkinson, MSN, RN & Alexandra Kozedub, ARNP
(206) 768-5338