This phase 3 clinical trial is investigating the effects of pemafibrate (Parmodia) on cardiovascular disease in people with type 2 diabetes (T2D). The main outcome to be measured will be the number of patients that experience a heart attack, stroke, death from cardiovascular causes, or who have to be hospitalized for unstable angina (severe chest pain that occurs even at rest).
The details
People with T2D are at increased risk of developing cardiovascular disease. Pemafibrate is a type of drug called a PPARα-agonist. PPARα-agonists can reduce the risk of heart disease by lowering triglycerides (a type of fat found in the blood).
This study will examine the safety and effectiveness of pemafibrate. The main outcome will be measured as the number of patients that experience a heart attack, stroke, death from cardiovascular causes, or who have to be hospitalized for unstable angina.
Who are they looking for?
This trial is looking for 10,000 adults with T2D and high triglycerides.
Participants may not use any PPARα-agonists in the 6 weeks before starting the trial. They may not start using a new triglyceride-lowering drug in the 3 months before starting the trial.
How will it work
The participants will be divided, randomly, into two groups. One group will receive a pemafibrate tablet twice a day. The other group will receive a placebo (drug with no active effect) tablet twice a day. The participants will be followed up for 4 years.
Cholesterol, triglycerides, and other fats in the blood will be measured after 3 weeks, and after 4 months. Any heart attacks, stroke, hospitalization for unstable angina, death, hospitalization for heart failure, or procedures performed on the blood vessels supplying the heart will be noted. Any disease that develops in the blood vessels of the arms and legs will be noted.
