Assessing ezefeno for patients with dyslipidemia and type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the long-term efficacy and safety of ezefeno, a combination therapy of ezetimibe and fenofibrate, in patients with dyslipidemia who have not achieved adequate control of their Non-HDL-C levels despite moderate-intensity statin therapy. It is a randomized, open-label, parallel, multicenter trial that aims to monitor major adverse cardiovascular and microvascular events over a 48-month period. The study will involve dose escalation of moderate-intensity statins alongside ezefeno treatment to determine its effectiveness in managing lipid levels and reducing cardiovascular risks.

Why it matters

Who can join: the full rules

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

Where it's running

• Korea University Anam Hospital
  Seoul, South Korea Recruiting

Study contacts

• Principal investigator: Sin-Gon Kim — Korea University Anam Hospital
• Study coordinator: Sin-Gon Kim
• Email: k50367@korea.ac.kr
• Phone: 8229205890

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.