Table of Contents
- Trial overview
- Conditions and patient groups
- Trial phases and study design
- Main endpoints and what they mean
- Trial-by-trial summary
- What patients should know from the trial data
Trial overview
These studies are testing Maridebart Cafraglutide in adults across several health problems, including weight management, type 2 diabetes, heart disease, heart failure, and obstructive sleep apnea.[1][2][3][4][5][6][7]
Most of the listed studies are interventional trials, which means the researchers give a study treatment or a comparison treatment and then measure results.[1][2][3][4][5][6][7]
The studies are mainly designed to see whether Maridebart Cafraglutide is better than placebo for important health outcomes.[1][2][3][4][5]
Conditions and patient groups
The trials include different adult groups, depending on the condition being studied.[1][2][3][4][5][6][7]
Adults with overweight or obesity: Several studies focus on chronic weight management in people who have overweight or obesity, with or without type 2 diabetes.[2][4][7]
Adults with type 2 diabetes: One Phase 2 study looks at adults with type 2 diabetes mellitus and checks how different doses affect glucose control.[4]
Adults with heart disease: One large Phase 3 study includes people with atherosclerotic cardiovascular disease and overweight or obesity.[1]
Adults with heart failure: Another Phase 3 study includes adults with heart failure with preserved or mildly reduced ejection fraction and obesity.[3]
Adults with obstructive sleep apnea: One Phase 3 study includes adults with moderate to severe obstructive sleep apnea who also live with overweight or obesity and are on positive airway pressure therapy.[5]
Trial phases and study design
There are Phase 3 and Phase 2 trials in the data.[1][2][3][4][5][6][7]
Phase 3 studies are the largest group here, including the trials for cardiovascular outcomes, chronic weight management, heart failure, type 2 diabetes with overweight or obesity, and obstructive sleep apnea.[1][2][3][4][5]
Phase 2 studies are smaller and include a dose-ranging study in type 2 diabetes and another dose-ranging study in overweight or obesity, with or without type 2 diabetes.[4][7]
One trial is listed as Completed, while the others are listed as Authorised.[1][2][3][4][5][6][7]
Main endpoints and what they mean
A primary outcome is the main result the researchers want to measure in a study.[1][2][3][4][5][6][7]
In the weight management studies, the main endpoint is percent change in body weight, usually measured at week 72 or week 52.[2][4][7]
In the type 2 diabetes dose-ranging study, the main endpoint is the change in HbA1c, which is a blood test that shows average blood sugar over time.[4]
In the cardiovascular outcomes study, the main endpoints are time to the first major adverse cardiac events, which include death from cardiovascular causes, heart attack, and ischemic stroke, and a second combined outcome that also includes all-cause death, coronary revascularization, and heart failure events.[1]
In the heart failure study, the main outcome is time to the first event in a combined endpoint of cardiovascular death, hospitalization for heart failure, or urgent heart failure visits.[3]
In the sleep apnea study, the main outcome is change in AHI, or Apnea-Hypopnea Index, which measures how often breathing stops or becomes shallow during sleep.[5]
Trial-by-trial summary
2024-516652-18-00: This Phase 3 study, called MARITIME-CV, includes participants with atherosclerotic cardiovascular disease and overweight or obesity. It is designed to compare Maridebart Cafraglutide with placebo and measure major heart and blood vessel events.[1]
2024-515524-36-00: This Phase 3 study, called MARITIME-1, includes adults without type 2 diabetes who have obesity or are overweight. It measures body weight change at week 72 and compares Maridebart Cafraglutide with placebo.[2]
2024-516654-22-00: This Phase 3 study, called MARITIME-HF, includes adults with heart failure with preserved or mildly reduced ejection fraction and obesity. It looks at heart failure hospitalizations, urgent visits, and cardiovascular death.[3]
NCT06858878: This Phase 3 study, called MARITIME-2, includes adults with type 2 diabetes mellitus who have obesity or are overweight. It measures percent change in body weight at week 72 and compares the study drug with placebo.[4]
NCT06660173: This Phase 2 dose-ranging study includes adults with type 2 diabetes mellitus. It measures change in HbA1c at week 24 and looks at the dose-response relationship, meaning how different doses affect the result.[4]
2025-522703-14-00: This Phase 3 study, called MARITIME-OSA-1, includes adults with moderate to severe obstructive sleep apnea and overweight or obesity who are on positive airway pressure therapy. It measures change in AHI at week 52.[5]
NCT05669599: This Phase 2 completed study included adults with overweight or obesity, with or without type 2 diabetes. It measured percent change in body weight at week 52 and compared several doses with placebo.[7]
What patients should know from the trial data
The trial data show that Maridebart Cafraglutide is being studied in several different adult populations, not just one disease area.[1][2][3][4][5][7]
Some studies are focused on weight loss, while others are focused on heart outcomes, blood sugar control, or sleep apnea severity.[1][2][3][4][5][7]
The large Phase 3 studies suggest that researchers are trying to find out whether the treatment can improve major health outcomes in bigger groups of patients, while the Phase 2 studies help explore dose and early effects.[1][4][7]
Across the listed trials, the comparison treatment is often placebo, which helps show whether any changes are linked to Maridebart Cafraglutide rather than chance alone.[1][2][3][4][5][7]
