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NCT Number: NCT06293417

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

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

Recruiting

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Key information

Conditions

T2DM (Type 2 Diabetes Mellitus) Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Korea University Anam Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Sin Gon Kim, MD

CONTACT

Sin Gon Kim, MD, PHD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ezetimibe/fenofibrate (Ezefeno) and moderate-intensity statin

Drug

Treatment group

Dose escalation of moderate-intensity statin

Drug

Control group

Primary outcomes

  1. major adverse cardiovascular events and diabetic microvascular events for 48 months

    Time frame: 48month from baseline

    major adverse cardiovascular events and diabetic microvascular events for 48 months

Secondary outcomes

  1. proportion of patients achieving Non-HDL-C less than 100mg/dL

    Time frame: 48month from baseline

    proportion of patients achieving Non-HDL-C less than 100mg/dL

  2. proportion of patients achieving LDL less than 70mg/dL

    Time frame: 48month from baseline

    proportion of patients achieving LDL less than 70mg/dL

  3. change in Non-HDL-C at 48month from baseline

    Time frame: 48month from baseline

    change in Non-HDL-C at 48month from baseline

  4. change in LDL at 48month from baseline

    Time frame: 48month from baseline

    change in LDL at 48month from baseline

  5. change in HDL-C at 48month from baseline

    Time frame: 48month from baseline

    change in HDL-C at 48month from baseline

  6. change in TG at 48month from baseline

    Time frame: 48month from baseline

    change in TG at 48month from baseline

  7. change in LDL-C/HDL-C ratio at 48month from baseline

    Time frame: 48month from baseline

    change in LDL-C/HDL-C ratio at 48month from baseline

  8. change in TC/HDL-C ratio at 48month from baseline

    Time frame: 48month from baseline

    change in TC/HDL-C ratio at 48month from baseline

Study contacts

Contact information is provided by the study sponsor or research team.

SIN-GON KIM

CONTACT

[email protected]

8229205890

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Registry information

Official study title

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

Acronym: ENSEMBLE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 5, 2024
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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