Assessing ezefeno for patients with dyslipidemia and type 2 diabetes
To Assess the Long-term Efficacy and Safety of Combined Therapy With Ezefeno Tab. in Patients With Dyslipidemia Who do Not Achieve Adequate Control of Non-HDL-C Levels Even With Moderate-intensity Monotherapy
This study is testing if a new combination treatment called ezefeno can help people with high cholesterol and type 2 diabetes lower their cholesterol levels and reduce heart risks when other medications aren't enough.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3958 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Korea University Anam Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06293417 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older with type 2 diabetes and elevated Non-HDL-C levels despite moderate-intensity statin therapy.
Not a fit: Patients with uncontrolled hyperglycemia, myopathy, or certain genetic disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve lipid control and reduce cardiovascular risks in patients with type 2 diabetes and dyslipidemia.
How similar studies have performed: Other studies have shown promise in using combination therapies for dyslipidemia and diabetes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.