RecruitingNot ApplicableNCT06293417

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

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


Sponsor

Korea University Anam Hospital

Enrollment

3,958 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this Randomized controlled trials is to assess in the long term efficacy and safety of ezefeno. The primary endpoint are: * major adverse cardiovascular events within 48 months of the trial duration * microvascular events within 48 months of the trial duration


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether a combination cholesterol medication (Ezefeno, combining ezetimibe and fenofibrate) safely lowers non-HDL cholesterol and triglycerides in people with Type 2 diabetes and high cardiovascular risk. **You may be eligible if...** - You have been diagnosed with Type 2 diabetes - You are 19 years or older - Your non-HDL cholesterol is 100 mg/dL or higher and your triglycerides are between 200–500 mg/dL while on moderate-intensity statin therapy - You have at least one cardiovascular risk factor **You may NOT be eligible if...** - You are pregnant or breastfeeding - Your blood sugar is very poorly controlled (HbA1c above 12%) - You have muscle disease (myopathy or rhabdomyolysis) - Your liver enzymes are more than 3 times the upper limit of normal - You have certain rare genetic conditions affecting sugar or lactose metabolism Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEzetimibe/fenofibrate (Ezefeno) and moderate-intensity statin

Treatment group

DRUGDose escalation of moderate-intensity statin

Control group


Locations(1)

Korea University Anam Hospital

Seoul, South Korea

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NCT06293417


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