To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM

Launched by KOREA UNIVERSITY ANAM HOSPITAL · Feb 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called ezefeno to see how effective and safe it is for people with type 2 diabetes and certain cholesterol issues known as dyslipidemia. The main focus is to find out if ezefeno can help reduce serious heart problems and other complications related to small blood vessels over a period of four years.

To participate in this trial, individuals must be at least 19 years old and have a diagnosis of type 2 diabetes. They should also have specific cholesterol levels while being treated with moderate-intensity statins, and have other factors that put them at risk for heart disease. However, pregnant or breastfeeding women, those with uncontrolled diabetes, and people with certain muscle or liver conditions cannot join the study. Participants will be monitored over time to see how well the medication works and if there are any side effects. This trial is currently recruiting individuals of all genders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with type 2 diabetes diagnosed by American Diabetes Association criteria
• • Age ≥ 19 years
• • Non-HDL-C ≥100 mg/dL, TG ≥200, \<500 mg/dL on moderate-intensity statins
• • with cardiovascular risk factor
• Exclusion Criteria:
• • Pregnant or breastfeeding women
• • Uncontrolled hyperglycemia(more than 12.0% for Subject treated with anti-diabetic treatment.)
• • Patient with myopathy and rhabdomyolysis
• • AST/ALT more than 3 ULN
• • Clinical evidence of genetic disorders such as galactose intolerance, Lapp lactose deficiency, and/or glucose-galactose malabsorption