To Assess With Ezefeno Tab. in Patients With Dyslipidemia and T2DM (ENSEMBLE)

Korea University

Status: Enrolling

Conditions: Dyslipidemias; T2DM (Type 2 Diabetes Mellitus)

Treatments: Drug: Dose escalation of moderate-intensity statin; Drug: Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin

Study type: Interventional

Funder types: Other

Identifiers

NCT06293417

HT-EF-01

Details and patient eligibility

About

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

Full description

A prospective, randomized, open-label, parallel, multicenter, active-drug-controlled clinical trial 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.

Enrollment: 3,958 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,958 participants in 2 patient groups

Treatment group

Experimental group

Description:

Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin

Treatment:

Drug: Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin

Control group

Active Comparator group

Description:

Dose escalation of moderate-intensity statin

Treatment:

Drug: Dose escalation of moderate-intensity statin