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

Recruiting now · Not applicable

Conditions studied: T2DM (Type 2 Diabetes Mellitus), Dyslipidemias

In brief

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

Key facts

Study ID

NCT06293417

Run by

Korea University Anam Hospital

People needed

3958

Starts

2024-03-01

Expected to finish

2027-02-01

Last updated by the study team

2024-08-27

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Korea University Anam Hospital — Seoul, South Korea (enrolling)

Full record on ClinicalTrials.gov

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